J Oral Maxillofac Surg

55:25-30, 1997, Suppl 5

The Influence of O. 12% Chlorhexidine

Digluconate Rinses on the Incidence of
Infectious Complications
and Implant Success
PAUL M. LAMBERT, DDS,* HAROLD F. MORRIS, DDS, MS,t AND
SHIGERU OCHI, PHDt

The effect of perioperative chlorhexidine on the frequency of infectious com-

plications through stage II was examined. Chlorhexidine was used periopera-
tively in 54.6% of patients (52.5% of implants) in a Dental Implant Clinical
Research Group study with a database of 2,641 implants (595 patients). With
chlorhexidine, there was a significant reduction in the number of infectious
complications (4.1% vs 8.7%). Two percent of implants failed in the absence
of an infectious complication, whereas 12% with infectious complications
failed. This sixfold difference is highly significant. Chlorhexidine may reduce
microbial complications when used in the immediate perioperative period.

The causal relationship between tooth loss and peri-
odontal disease is widely recognized. Replacement of
lost teeth has always been one of the fundamental goals
of dental practice. Provision of fixed or removable
prostheses has long been the standard treatment for
this clinical problem. However, both modalities have
limitations to their usefulness and in their acceptance
by patients. Among these are instability, pain, de-
creased masticatory efficiency, and damage to other-
wise healthy teeth. In recent decades, osseointegrated
dental implants have been used with increasing fre-
quency to overcome these limitations. It has been esti-
mated that approximately 642,000 dental implants
* Chief, Dental Service. Department of Veterans Affairs Medical
Center, Dayton, OH; Assistant Professor, College of Dentistry. The
Ohio State University, Columbus, OH; Assistant Clinical Professor.
School of Medicine. Wright State University, Dayton, OH.
t Codirector, Dental Clinical Research Center; Project Codirector,
Dental Implant Clinical Research Group, Department of Veterans
*
Affairs Medical Center, Dental Research, Ann Arbor, MI.
Codirector, Dental Clinical Research Center; Project Codirector
and Biostatistician, Dental Implant Clinical Research Group. Depart-
ment of Veterans Affairs Medical Center, Dental Research, Ann
Arbor, MI.
Address correspondence and reprint requests to Dr Morris: Dental
Research (154), Department of Veterans Affairs Medical Center.
Ann Arbor, MI 48105.
This is a US government work. There are no restrictions on its
use.
0278-2391/97/5512-5006$0.00/0
were placed by private practicing dentists in the United
States during 1990.\
Although dental implant rehabilitation is an effec-
tive and predictable modality for replacement of miss-
ing dentition, it is not free of complications or failure.
One of the most common complications is peri-im-
plantitis. In fact, it has been shown that peri-implant
tissues are as vulnerable to destruction by the periodon-
tal pathogenic process as natural teeth.i" Of equal con-
cern is the finding that patients who have previously
had periodontal disease are at highest risk of devel-
oping further periodontal disease.'
Dental rehabilitation with osseointegrated implants
is highly successful, but failures can and do occur at
all stages of the process, from placement through resto-
ration and maintenance of the final prosthesis. The
causes of failure may be separated into three broad
categories: 1) poor surgical technique, 2) occlusal
overload, and 3) microbiologic factors.
Efforts to control microbiologic factors have most
often been directed toward establishing professional
and home care of implants after exposure to the oral
environment and placement of the final prosthesis. Es-
tablishment of effective preventive regimens to control
plaque by mechanical and chemotherapeutic means has
received considerable attention in recent literature.
However, little attention has been paid to preventive
strategies that can be used during the perioperative
periods at placement and uncovering.

25
26
In recent years, considerable attention has been fo-
cused on the role of topical antimicrobials as adjuncts
to therapy for and in prevention of periodontal dis-
ease.l" One agent in particular, 0.12% chlorhexidine
digluconate (CHX), has been shown to be an effective
aid in treatment of periodontal disease. In addition, it
has been shown to promote healing and reduce surgical
complications. Oral rinsing and irrigation with CHX
have been shown to reduce naturally occurring gingivi-
tis.6-9 Brownstein et al 6 reported significantly reduced
plaque accumulation, decreased gingival bleeding, and
lowered mean log of colony-forming units of Actino-
myces species with either twice-daily rinses or once-
a-day irrigation."
Beiswanger et al' studied the effect of a CHX rinse
on gingival healing after scaling and root planing."
After baseline measurements were recorded, test sub-
jects used '/2 ounce of chlorhexidine twice daily for
30 seconds, 2 weeks before and 2 weeks after scaling
and root planing of opposing quadrants on one side of
the mouth. The remaining quadrants were treated, and
an additional 2 weeks of CHX use was completed.
Compared with the placebo groups, chlorhexidine
rinses resulted in significantly better gingival healing.
Evidence for this improvement included 29% less gin-
givitis, 48% fewer bleeding sites, and 54% less plaque.
There was no significant difference between 2 or 4
weeks' duration of chlorhexidine rinses.
Perioperative rinses with 0.12% digluconate also
have been shown to be an effective adjunct that can
reduce or aid in reversal of complications in various
intraoral surgical procedures.'?"? Hammerle et al'" re-
ported reversal of severe peri-implantitis. Chlorhexi-
dine was used during debridement and after placement
of a polytetrafluoroethylene membrane around the
necks of two implants with up to 7.1 mm loss of sup-
porting bone. One year after membrane removal, bone
gain as great as 3.6 mm was seen, and both implants
were maintained.
Several investigators have shown that perioperative
chlorhexidine rinses can reduce the incidence of alveo-
lar osteitis ("dry socket"), one of the most perplexing
complications that can follow removal of impacted
mandibular molar teeth.":" Larsen!' reported a 73%
reduction of alveolar osteitis when impacted mandibu-
lar third molars were removed by an inexperienced
surgeon and 50% when removed by an identically
trained but. more experienced surgeon. Both results
were found to be statistically significant. In a double-
blind study of 160 surgical sites in 80 patients, Ragano
and Szkutnik 12 showed a statistically significant reduc-
tion (14/80 vs 29/80) in the incidence of dry socket
when patients rinsed with 0.12% chlorhexidine for 30
seconds before removal, after removal but before clo-
sure of the site, and twice daily for 7 days postopera-
tively." There is ample evidence suggesting that bacte-
CHLORHEXIDINE EFFECT ON IMPLANT SUCCESS
rial contamination is a major causative factor in
alveolar osteitis. Therefore, it should not be surprising
that an antimicrobial solution is effective in reducing
the incidence of a surgical complication in which mi-
crobes play a significant role.
Before the use of topical antimicrobials was advised
in this study, the literature was reviewed to determine
whether they might adversely affect implant surfaces.
Thomson-Neal et al" exposed several implant types,
including those used in this study (titanium and hy-
droxyapatite [HAl-coated), to the equivalent of 15
years of twice-daily 30-second rinses with 0.12%
chlorhexidine solution in vitro." They found no sur-
face alteration of any implant type that could be de-
tected by scanning electron microscopy. The authors
concluded that chlorhexidine mouth rinses could be
recommended for implant maintenance.
The purpose of this article is to report on the effec-
tiveness of perioperative chlorhexidine rinses in reduc-
ing the incidence of infectious complications and im-
plant failures during the closed healing period
associated with the placement of endosseous root-form
dental implants.
Materials and Methods
The analysis presented is generated from the data-
base of the Dental Implant Clinical Research Group
(DICRG), which in 1991 initiated a long-term, ran-
domized, prospective, multidisciplinary clinical study
with two distinct independent groups (study group A,
study group B) to investigate the influence of implant
design, application, and site of placement on clinical
success and crestal bone height. 19 Study group A com-
prises 17 clinical centers; study group B, 15 clinical
centers. Distinctions between the two groups include
amount of prior surgical experience with implants."
type of alloy for restorations (each assigned four
alloys), geographic regions from which patient sam-
pling was done, and home care regimen (manuai or
electric toothbrush with or without antimicrobial
rinses) (Table 1). Study patients are largely veterans
eligible for dental treatment at VA centers nationwide,
but also include patients from two dental schools. They
range in age from 20 years to more than 80 years and
are, for the most part, white and male. Initial screening
was done to ensure suitability for treatment with dental
implants; extensive medical and dental histories were
taken."
Implants included in these ongoing studies are as
follows: HA-coated endosseous implant with ledged
body design and internal hex-thread connection (HA-
coated grooved); endosseous implant with externally
threaded body and internal hex-thread connection, and
with three material options: commercially pure tita-
nium, titanium alloy, and HA-coated (Ti screw, Ti
LAMBERT ET AL
Table 1. DICRG Postoperative and Home Care Protocol for Toothbrushing and Antlmlcrobl.1 Rln...
A B
Stage
I-II Chlorhexidine rinses Chlorhexidine rinses
x 2 wk postoperatively x 2 wk postoperatively
III-IV Electric toothbrush but no Electric toothbrush and
chlorhexidine rinses chlorhexidine rinses
NOTE. Stage I starts with the placement surgery and continues until the time of surgical uncovering; stage II is the point of surgical
uncovering; stage 1II is the time between surgical uncovering and occlusal loading; and stage IV starts with occlusal loading.
alloy screw, HA-coated screw); HA-coated endosseous
implant with a cylindrical body and internal hex-thread
connection (HA-coated cylinder); titanium alloy en-
dosseous implant with a basket design, externally
threaded body, and internal hex-thread connection (Ti
alloy basket). All are available in two diameters except
the screw, which is available in one diameter, and in
four lengths, ranging from 7 or 8 mm to 16 mm. These
implant designs constitute the Spectra-System (Core-
Vent Corporation, Las Vegas, NV). The type of im-
plant used for a given location was determined by a
randomized assignment of implant design as described
in the study design; however, length and diameter were
chosen by the treatment team. 19 Chlorhexidine digluco-
nate 0.12% (Peridex, Proctor & Gamble, Cincinnati,
OH) was provided to the clinical investigators for use
by their study patients.
Clinical investigators in each study group were ori-
ented to the clinical protocols, evaluation criteria, and
data collection procedures. Although the study proto-
col recommended the use of chlorhexidine rinses im-
mediately before implant placement surgery and un-
covering surgery, and twice daily for 2 weeks after
surgery, clinical investigators were free, according to
their own practice pattern, to prescribe it or not to
prescribe it. Clinicians choosing to prescribe chlorhexi-
dine and those who chose not to prescribe it were
divided so that the number of implants in each group
was similar and sufficient for analysis. Standardized
forms were used to collect data. The prescribing of
chlorhexidine was documented for each study case on
the Implant Placement form (form 03) and on the Im-
plant Uncovering form (form 04). Once prescribed by
the surgeon, patient compliance was monitored by re-
quests for another bottle of chlorhexidine.
Mandibular implants were to be surgically uncov-
ered at least 4 months after placement and maxillary
implants at least 6 months after placement. At the time
of uncovering, the following were documented: the
status of the implant (osseointegrated, integrated/non-
functional, not osseointegrated); the distance between
top of implant and crest of bone; Periotest value of the
27
Group
2
Chlorhexidine rinses Chlorhexidine rinses
x 2 wk postoperatively x 2 wk postoperatively
Manual toothbrush but no Manual toothbrush and
chlorhexidine rinses chlorhexidine rinses
implant (Periotest, Siemens AG, Bensheim, Germany);
type of incision (crestal, remote, tissue-punched); and
medications prescribed.
Complications and their treatments were docu-
mented during all phases of treatment. For this analy-
sis, several fields on the Complication form were
combined to form the category "infectious complica-
tions." These fields were "peri-implant infection,"
"peri-implantitis," "infection of soft tissue extra-
orally," "systemic infection secondary to implant,"
"persistent febrile condition," "osteomyelitis-
acute," and "osteomyelitis-chronic." All reports of
infectious complications were based on clinical obser-
vations and not on microbiologic testing, with the ex-
ception of one report that did include the results of
such testing. No cases of systemic infection, persistent
febrile condition, or chronic osteomyelitis were re-
ported.
Data entry was done by staff of the data management
center, and analysis of data was done by the DICRG
study biostatistician. For the analyses presented,
"treatment" means use of perioperative chlorhexidine
rinses, and "control" means perioperative chlorhexi-
dine was not used. This clustering has no relation with
the home care groups (row 2 of Table 1) to which
clinical centers were randomized at entry into the study
and which were implemented after uncovering of the
implants. -
Results
The results for the treatment and control groups were
analyzed on an implant basis and a patient basis both
by study group (A and B) and by pooled data. The
varying number of implants in the different study
strata, and the fact that one patient could have several
study cases (prostheses), placed the results in matiy
different combinations for analysis. Although implants
could be considered independent experimental units
until uncovered, there is always a debate about whether
the experimental unit is the implant or the patient;
therefore, the results for both units are presented in
28
Table 2. Infectlou. Complication. of Implante
With and Without Chlorhexldlne U.e (A & B
Pooled)
Infection (%) No Infection Total
Treatment 57 (4.1) 1,330 1,387
Control 109 (8.7) 1,145 1,254
Total 166 2,475 2.641
this article. The first comparison focuses on the use of
chlorhexidine by each experimental unit and the rate
of infectious complications recorded. The second com-
parison is the influence of the presence of an infectious
complication on the failure of implants to integrate.
CHLORHEXIDINE AND INFECTIOUS COMPLICATIONS
Implants
Data collected on 2,847 implants placed and 2,641
uncovered in the DICRG database as of May 1995
form the basis for the statistics reported. Of the total
2,641 implants, study groups A and B placed and un-
covered 1,255 and 1,386 implants. respectively. Group
A investigators prescribed chlorhexidine rinses slightly
more frequently than did the investigators in group B.
Of the implants placed by group A, 60.8% (763/1,255)
were in the treatment group, and 39.2% (49211,255)
were in the control group. In group B, 45% of implants
(624/1,386) were in patients using chlorhexidine rinses
and 55% (762/1 ,386) were not. Investigator preference
created a treatment group and control group of almost
identical size when the data were pooled. A total of
2.641 implants were placed, and 52.5% (1,387/2,641)
were analyzed as the treatment group and 47.5%
(1,254/2,641) as the control group.
In group A, the rate of infectious complications was
2.8% (211763) for the treatment (chlorhexidine) group
versus 6.7% (33/492) in the control group. The control
group experienced a rate of infectious complications
more than twice that of the treatment group. This
difference was statistically significant (P = .001, chi-
square test). In group B, the rates of infectious compli-
cations for the control and treatment groups were simi-
lar to those in group A. The control group experienced
about twice the number of infectious complications
that the treatment group did, 10% (76/762) versus 5.8%
(36/624). This difference was statistically significant
(P = .004, chi-square test).
The relation between the use of chlorhexidine and
the incidence of infectious complications (pooled data)
is shown in Table 2. Chlorhexidine rinses were pre-
scribed perioperatively (implant placement surgery)
for 1,387 implants and not prescribed for 1,254 im-
plants. An infectious complication was reported for 57
CHLORHEXIDINE EFFECT ON IMPLANT SUCCESS
of 1,387 implants (4.1%) in which chlorhexidine was
used and 109 of 1,254 implants (8.7%) in which chlor-
hexidine was not used. These results indicate a highly
significant reduction in the number of infectious com-
plications in patients who received chlorhexidine dur-
ing the immediate postoperative period after stage I
surgery (P = .001 using the chi-square test).
Patients
During the accrual period, group A entered 290 pa-
tients and group B, 305. In group A, 177 (61 %) were
provided chlorhexidine, and 113 (39%) were not. In
group B, 148 (48.5%) patients were provided chlorhex-
idine and 157 (51.5%) were not.
In group A, an infectious complication was recorded
for the treatment group in 4.5% of the patients, which
was slightly more than half that of the 8% complica-
tions in the control group (P = .228, chi-square test).
The infectious complication rate for the patients in
group B was very similar to that of patients in group A.
The treatment group reported complications for 7.4%
compared with 10.2% for the control group. When the
data for the two groups were pooled (Table 3), the
patients in the treatment group had a 5.8% infectious
complication rate, compared with 9.3% in the control
group (P = .397, chi-square test).
Although infectious complications occurred less fre-
quently when chlorhexidine rinses were used, the same
held true for preoperative antibiotics. When preopera-
tive antibiotics were used, the rate of infectious compli-
cations was essentially the same whether or not chlor-
hexidine rinses were used (7.09% with CHX; 7.29%
without CHX). However, when preoperative antibiot-
ics were not used, there was a significant difference
between the two groups (8.29% with CHX; 14.62%
without CHX) (P = .001).
INFECTIOUS COMPLICATIONS AND IMPLANT FAILURE
Implants
When an infectious complication was recorded,
there was an increase in the probability of implant
failure. In study group A, when an infectious complica-
tion was reported, 7 of 54 implants (13%) failed to
integrate, compared with only 20 of 120 I (1.7%) when
Table 3. Patlente With Infectious
Complications (Pooled)
Infection (%) No Infection Total
Treatment 19 (5.8) 306 325
Control 25 (9.3) 245 270
Total 44 551 595
LAMBERT ET AL
no complication was present. This represented a 7.6
times greater probability of failure when a complica-
tion was reported (P = .001, chi-square test). In study
group B, the results were very similar. There was a
five times higher probability of failure to integrate (P =
.001, chi-square test) when a complication was present
(11.6%, n = 13/112) compared with those not associ-
ated with an infectious complication (2.3%, n = 29/
1,274). The pooled data from groups A and B showed
very similar results, with 12.0% (20/166) of the im-
plants associated with an infectious complication fail-
ing compared with only 2.0% (49/2,475) when no com-
plication was present (P = .001, chi-square test).
Patients
In the event that an infectious complication was re-
corded for a patient, there was an increased possibility
for an implant not to integrate. In study group A, when
an infectious complication was recorded, the failure
rate was 35.3% (6 of 17), compared with only 5.9%
(16 of 273) when such a complication was not present,
which is about 6 times greater than that without a
complication (P = .001, chi-square test). Patients in
study group B followed a similar trend, with a nearly
fivefold difference in failure rate. With an infectious
complication, 40.7% (11 of 27) of patients experienced
an implant failure, compared with 8.6% (24 of 278)
when an infectious complication was not present (P
= .001, chi-square test). For the pooled data, those
associated with an infection were about 5 times more
likely to fail to integrate (38.6%, n = 17 of 44) as
when no infection was encountered (7.3%, n = 40 of
551) (P = .001, chi-square test).
Discussion
The two independent study groups in the DICRG
had comparable subgroups for perioperative chlorhexi-
dine use at the time of implant placement surgery,
thereby allowing combining of the databases and
grouping of the chlorhexidine (treatment) subgroups
and nonchlorhexidine (control) subgroups. We found
that I) the use of perioperative chlorhexidine oral
rinses significantly reduced the incidence of infectious
complications occurring during the closed healing pe-
riod; and 2) the occurrence of infectious complications
was significantly associated with implant failure oc-
curring during the closed healing period. These results
suggest that chlorhexidine oral rinses may be beneficial
in reducing microbial-based complications when rou-
tinely used in the perioperative period. Reducing these
complications could reduce the number of failures at
stage II uncovering surgery.
The similarities between peri-implantitis and peri-
odontal disease are striking. The same pattern of de-
29
struction and population of microorganisms is seen in
both processes." Ong et al23 examined the microorgan-
isms found in the peri-implant space in 19 patients.
The study's specific purpose was to determine the oc-
currence of three organisms-Actinobacillus actino-
mycetemcomitans, Porphyromonas glnglvalis, and
Prevotella intermedia. These organisms represent
some of the major species found in periodontitis.f All
patients were healthy and had clinically sound titanium
implants that had abutments in place for at least 3
months before sampling. Thirty-seven sites were sam-
pled. Only A actinomycetemcomitans and P intermedia
were cultured. In contrast, Mombelli et al 22 recovered
P intermedia and P gingivalis, but not A actinomycet-
emcomitans.P Apse et al 2s found all three organisms;
however, the implant sulci were inflamed. George et
al 26 evaluated clinical and microbiologic parameters in
24 patients with 98 implants. They evaluated probing
depth (PD), plaque/calculus index, gingival bleeding
index (OBI), mobility, and crevicular fluid flow rate
(CFFR). The presence of A actinomycetemcomitans, P
gingivalis, and P intermedia in subgingival plaque was
identified by latex agglutination assays. The presence
of anyone of these microorganisms in subgingival
sites was associated with significantly greater PD, OBI,
and CFFR scores than noncolonized sites. 26 It is clear
that the so-called periodontal pathogens can be found
in the peri-implant space, and it is reasonable to assume
that they are present in the mouth at the time of implant
placement and abutment attachment. Therefore, reduc-
tion of the population of these pathogens immediately
before and during healing for both stage I and stage
II surgery should be considered as part of the treatment
plan.
Chlorhexidine has been shown to alter the bacterial
cell wall so that lysis occurs. It has high substantivity,
which gives it the ability to be retained in the oral
cavity and be released over an extended period without
significant loss of potency." Chlorhexidine is effective
in reducing microorganisms associated with periodon-
tal disease. It is known that oral rinsing with chlorhexi-
dine can reduce gingivitis and decrease the incidence
of complications in other intraoral surgical proce-
dures/,·9.ll
on
Lavigne et al 28 compared the effect of a single pro-
fessional irrigation with 0.12% chlorhexidine, sterile
solution, or no irrigation on the periodontal health of
patients with hydroxyapatite-coated dental implants,
reflected by standard indices, including probing depth,
bleeding index, pocket temperature, pathogens, and
beta-glucuronidase (BO) activity in gingival crevicular
fluid. There were no differences between any of the
treatment groups. Lack of significance might suggest
that a single professional irrigation does not improve
the periodontal status of implants. However, all of the
subjects in this study were healthy patients with no
30
bleeding sites, normal pocket temperature, no peri-
odontopathic microorganisms, and normal BG activity
at baseline. All of these parameters are consistent with
absence of disease, and it should not be surprising
that differences could not be detected. The authors
hypothesized that chlorhexidine irrigation may have
had a preventive effect, because no other professional
treatment was performed, and none of the indices
worsened over the 8 weeks of the study.
A major cause of tooth loss is periodontal disease.
and it has been shown that the risk of development of
further disease is highest in patients with a history of
periodontal disease. Therefore, successful dental im-
plant treatment must include strategies to reduce this
risk. Antimicrobial therapy with chlorhexidine has
been shown to reduce periodontal disease and surgical
complications. In this study we have shown that chlor-
hexidine rinses were beneficial in reducing infectious
complications when routinely used in the perioperative
period. In view of the potential for development of
resistant strains of microorganisms as a result of using
systemic antibiotics, it may be more prudent to protect
against infectious complications with topical antimi-
crobial therapy. Reducing these complications could
ultimately reduce the number of failures at stage II
uncovering. A well-controlled prospective clinical trial
is suggested to confirm these findings.
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