Consumer Information
Chlorhexidine (Implantation-Local)
VA CLASSIFICATION
Primary: OR900
Commonly used brand name(s): PerioChip.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antibacterial (dental)—
Indications
General considerations
In clinical studies, chlorhexidine periodontal implants were found to reduce the numbers of organisms thought to be periodontopathic, including Porphyromonas (Bacteroides) gingivalis , Prevotella (Bacteroides) intermedia , Bacteroides forsythus , and Campylobacter rectus (Wolinella recta) {01}. No overgrowth of opportunistic organisms or other adverse changes in the oral microbial ecosystem were noted {01}.
Accepted
Periodontitis (treatment)—Chlorhexidine periodontal implants are indicated as an adjunct to scaling and root planing procedures for the reduction of pocket depth in patients with adult periodontitis {01}. Chlorhexidine periodontal implants may be used as a part of a periodontal maintenance program, which includes good oral hygiene and scaling and root planing {01}.
Unaccepted
The use of chlorhexidine periodontal implants in acutely abscessed periodontal pockets has not been studied and is not recommended {01}.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
Chlorhexidine gluconate: 897.77 {02}
Mechanism of action/Effect:
Bactericidal. Because of its positive charge, the chlorhexidine molecule reacts with the microbial cell surface to destroy the integrity of the cell membrane. The chlorhexidine molecule penetrates into the cell and precipitates the cytoplasm, and the cell dies {01}.
Absorption:
An in vivo study in 18 adult patients found no detectable plasma or urine chlorhexidine concentrations following insertion of four periodontal implants under clinical conditions {01}.
Time to peak concentration:
In contrast to in vitro data, in vivo data indicate a high degree of individual variability in chlorhexidine release from the periodontal implant {01}.
In vitro, chlorhexidine is released in a biphasic manner, with approximately 40% released within the first 24 hours and the rest released in an almost linear fashion over 7 to 10 days. This release profile may be explained as an initial burst effect, dependent on diffusion of chlorhexidine from the periodontal implant, followed by a further release of chlorhexidine as a result of enzymatic degradation {01}.
In one in vivo study, the biphasic release profile for chlorhexidine was highly variable; mean chlorhexidine concentration in gingival crevicular fluid (GCF) 4 hours after insertion of the four periodontal implants was 1444 ± 783 mcg per mL (mcg/mL), followed by a second peak at 72 hours of 1902 ± 1073 mcg/mL {01}. In a second study, there was an initial peak in GCF chlorhexidine concentration at 4 hours after insertion of one periodontal implant, with a mean of 1088 ± 678 mcg/mL, followed by a highly erratic decline to 482 ± 447 mcg/mL at 72 hours without ever achieving a true second peak {01}.
Precautions to Consider
Carcinogenicity
Studies have not been done {01}.
Mutagenicity
Chlorhexidine was not found to be mutagenic in a chromosome aberration assay in CHO cells, in vitro in the Ames test, or in vivo in a micronucleus assay in mice {01}.
Pregnancy/Reproduction
Pregnancy—
Although clinical studies found that the insertion of four implants into periodontal pockets resulted in plasma concentrations of chlorhexidine that were at or below the limit of detection, it is not known whether chlorhexidine periodontal implants can cause fetal harm when used in pregnant women or can affect reproductive capacity. Risk-benefit should be considered before use of chlorhexidine periodontal implants in pregnant women {01}.
Studies in animals have not been done, because no animal models are available that would permit use of a clinically relevant route of administration. Studies in rats given chlorhexidine by gavage at doses of up to 68.5 mg per kg of body weight (mg/kg) per day did not produce harmful effects in the fetus. However, the relevance of these data is questionable because of very poor absorption of chlorhexidine from the gastrointestinal tract. {01}
FDA Pregnancy Category C {01}.
Breast-feeding
It is not known whether chlorhexidine is distributed into breast milk. However, problems in humans have not been documented {01}.
Pediatrics
Safety and efficacy have not been established {01}.
Geriatrics
No information is available on the relationship of age to the effects of chlorhexidine periodontal implants in geriatric patients.
Dental
Because of the risk of dislodging the implant, it is recommended that the use of dental floss be avoided at the site of insertion for 10 days after placement. All other oral hygiene may be continued as usual {01}.
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Except under special circumstances, this medication should not be used when the following medical problem exists:
» Sensitivity to chlorhexidine{01}
Side/Adverse Effects
Note: Unlike chlorhexidine oral rinse, the use of chlorhexidine periodontal implants did not appear to cause tooth staining and altered taste perception in two clinical studies and an additional study of 619 patients {01}.
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence less frequent
Bronchitis (cough, congestion or tightness in chest, or wheezing)
hyperplasia of gums{01} (bleeding, tender, or enlarged gums)
Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
Tooth, gum, or mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity, mild to moderate{01}
Note: Most oral pain or sensitivity occurs within the first week after insertion of the initial implant and resolves within a few days without further treatment. Incidence decreases with repeat implant insertions at 3 and 6 months {01}.
Incidence less frequent
Dyspepsia (indigestion or upset stomach)
pharyngitis{01} (sore throat)
stomatitis, ulcerative{01} (ulcers or sores in mouth)
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Chlorhexidine (Implantation-Dental)—Introductory Version .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to chlorhexidine
Proper use of this medication
» Proper dosing
Not necessary to remove implants; physician will want to check depth of pockets every 3 months to determine need for re-treatment
Precautions while using this medication
» Avoiding flossing for 10 days after insertion to avoid dislodging implant
» Telling dentist right away if implant is dislodged
Side/adverse effects
Signs of potential side effects, especially bronchitis or hyperplasia of gums
General Dosing Information
It is recommended that each treated periodontal pocket be isolated and the surrounding area dried prior to insertion of the implant. The implant should be grasped with forceps (so that the rounded end points away from the forceps) and inserted into the periodontal pocket to its maximum depth. If necessary, the tips of the forceps or a flat instrument can be used to further maneuver the implant into position. {01}
It is not necessary to remove the implant, since it biodegrades completely {01}.
If the implant becomes dislodged (an unlikely event): —7 or more days after placement: the patient can be considered to have received that full course of treatment {01}.
—within 48 hours after placement: a new implant should be inserted {01}.
—more than 48 hours after placement: the implant should not be replaced, but the dentist should evaluate the patient after 3 months and insert a new implant if the depth of the periodontal pocket has not been reduced to less than 5 mm {01}.
Patients should avoid dental floss at the site of insertion for 10 days after placement because flossing might dislodge the implant. All other oral hygiene may be continued as usual. No restrictions regarding dietary habits are needed. Dislodging the implant is uncommon; however, patients should be instructed to notify the dentist promptly if the implant dislodges {01}.
Patients should be advised that, although some mild to moderate sensitivity is normal during the first week after placement of the implant, they should notify the dentist promptly if pain, swelling, or other problems occur {01}.
Dental Dosage Forms
CHLORHEXIDINE GLUCONATE IMPLANTS (PERIODONTAL)
Usual adult dose
Periodontitis
Periodontal, 1 implant inserted into a periodontal pocket that has a probing pocket depth of ³ five millimeters (mm). Up to 8 implants may be inserted in a single visit. Treatment may be repeated every three months in pockets that still have a probing pocket depth of ³ five mm {01}.
Usual pediatric dose
Periodontitis
Safety and efficacy have not been established {01}.
Strength(s) usually available
U.S.—
2.5 mg (Rx) [PerioChip (in a biodegradable matrix of hydrolyzed gelatin [cross-linked with glutaraldehyde]) (glycerin) (purified water)]
Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F) {01}.
Additional information:
Chlorhexidine periodontal implants are supplied as small, orange-brown rectangular chips that are rounded at one end. Each chip is individually packed in a separate compartment of an aluminum blister pack that contains 10 chips {01}.
Developed: 11/10/1998
References
- PerioChip package insert (Astra—US), Issued 5/98, Rec 7/15/98.
- Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1997. p. 154.
