Periochip

Description

PerioChip® (chlorhexidine gluconate) is a small, orange-brown, rectangular chip with a rounded end, designed for insertion into periodontal pockets. Each chip has an approximate weight of 7.4 mg and contains 2.5 mg of chlorhexidine gluconate, which is embedded in a biodegradable matrix of hydrolyzed gelatin that is cross-linked with glutaraldehyde. The formulation also includes glycerin and purified water. Chlorhexidine gluconate serves as an antimicrobial agent, chemically identified as 1,1’-hexamethylenebis 5-(p-chlorophenyl)biguanide di-D-gluconate, with a molecular formula of C22H30Cl2N10.2C6H12O7 and a molecular weight of 897.8.

Uses and Indications

PerioChip is indicated as an adjunct to scaling and root planing procedures for the reduction of pocket depth in patients with adult periodontitis. This drug may also be utilized as part of a comprehensive periodontal maintenance program, which includes good oral hygiene practices alongside scaling and root planing.

There are no teratogenic or nonteratogenic effects associated with PerioChip.

Dosage and Administration

One PerioChip should be inserted into each periodontal pocket with a probing pocket depth (PD) of 5 mm or greater. A maximum of 8 PerioChips may be inserted during a single treatment visit. It is recommended that treatment be administered once every three months for pockets that continue to have a PD of 5 mm or greater.

Prior to the insertion of the PerioChip, the periodontal pocket must be isolated, and the surrounding area should be dried thoroughly. The PerioChip should be grasped using forceps, ensuring that the rounded end points away from the forceps, and then inserted into the periodontal pocket to its maximum depth. If necessary, the PerioChip can be further maneuvered into position using the tips of the forceps or a flat instrument.

The PerioChip is designed to biodegrade completely and does not require removal. In the event of dislodgement, the following guidelines should be followed:

• If dislodgement occurs 7 days or more after placement, the patient should be considered to have received a full course of treatment.

• If dislodgement occurs within 48 hours after placement, a new PerioChip should be inserted.

• If dislodgement occurs more than 48 hours after placement, do not replace the PerioChip; instead, reevaluate the patient at the three-month mark and insert a new PerioChip if the pocket depth has not reduced to less than 5 mm.

Contraindications

PerioChip is contraindicated in patients with a known sensitivity to chlorhexidine due to the potential for adverse reactions. Additionally, the use of PerioChip in acutely abscessed periodontal pockets has not been studied; therefore, its application in this condition is not recommended.

Warnings and Precautions

The use of PerioChip in an acutely abscessed periodontal pocket has not been studied; therefore, its application in such cases is not recommended. Healthcare professionals should exercise caution when considering the adjunctive placement of PerioChip following scaling and root planing, as there have been rare reports of infectious events, including abscesses and cellulitis, associated with this procedure.

In managing patients with periodontal disease, it is essential to consider any potentially contributing medical disorders. Conditions such as cancer, diabetes, and immunocompromised status may influence treatment outcomes and should be taken into account during patient assessment and management. Regular monitoring of these underlying conditions is advised to ensure optimal patient care and to mitigate risks associated with periodontal treatment.

Side Effects

Patients may experience a range of adverse reactions associated with the use of the product. The most common adverse reactions reported include toothache (50.7%), upper respiratory tract infection (28.4%), headache (27.1%), and sinusitis (13.8%). Other frequently observed reactions include influenza-like symptoms (7.6%), back pain (6.7%), tooth disorder (6.2%), bronchitis (6.2%), abscess (5.8%), and pain (4.9%). Additional common reactions include allergy (4.0%), myalgia (4.0%), gum hyperplasia (3.6%), pharyngitis (3.6%), arthralgia (3.1%), dysmenorrhea (3.1%), dyspepsia (3.1%), rhinitis (2.7%), coughing (2.7%), arthrosis (2.7%), hypertension (2.2%), stomatitis ulcerative (2.2%), and tendinitis (2.2%).

In clinical trials, it was noted that most oral pain or sensitivity occurred within the first week following the initial chip placement after scaling and root planing (SRP) procedures. These reactions were generally mild to moderate in nature and resolved spontaneously within a few days. Furthermore, it was observed that these reactions occurred less frequently with subsequent chip placements at 3 and 6 months.

Additional adverse reactions of note include gingival bleeding, which occurred at a rate of ≤ 1% in both treatment groups. Although rare, infectious events such as abscesses and cellulitis have been reported with the adjunctive placement of the PerioChip following SRP procedures.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Periochip (chlorhexidine gluconate), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The safety and effectiveness of PerioChip in pediatric patients have not been established. There are currently no data available to support its use in children, infants, or adolescents. Healthcare professionals should exercise caution when considering treatment options for this population.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, were included in clinical studies of PerioChip; however, the number of subjects in this age group was insufficient to ascertain whether they respond differently compared to younger patients. Despite this limitation, other reported clinical experiences have not indicated any differences in responses between elderly and younger patients.

Furthermore, overall differences in safety or effectiveness have not been identified between geriatric patients and their younger counterparts. As such, no specific dosage adjustments or additional safety considerations are recommended solely based on age. However, healthcare providers should continue to monitor elderly patients closely, as individual responses may vary.

Pregnancy

Pregnancy Category C has been assigned to PerioChip, indicating that risk to the fetus cannot be ruled out. Animal reproduction studies have not been conducted due to the lack of suitable animal models that would allow for a clinically relevant route of administration. However, studies involving chlorhexidine gluconate, the active ingredient in PerioChip, have shown that it did not induce harm to the fetus when administered to rats via gavage at dosages up to 68.5 mg/kg/day. It is important to note that chlorhexidine is known to be very poorly absorbed from the gastrointestinal tract; however, absorption may occur following placement within a periodontal pocket.

In clinical studies, the placement of four PerioChips within periodontal pockets resulted in plasma concentrations of chlorhexidine that were at or below the limit of detection. Despite this, it remains unclear whether these findings are applicable to the clinical use of PerioChip in pregnant patients. Consequently, it is not known if PerioChip can cause fetal harm or affect reproductive capacity when administered to a pregnant woman. Therefore, PerioChip should be used in pregnant patients only if clearly needed, and healthcare professionals should weigh the potential benefits against the risks before prescribing this treatment.

Lactation

It is not known whether PerioChip is excreted in human milk. Caution should be exercised when PerioChip is administered to lactating mothers.

There are no data on the presence of chlorhexidine in human milk, the effects on breastfed infants, or the effects on milk production.

Renal Impairment

Patients with renal impairment do not require specific dosage adjustments, as no alterations in dosing are indicated in the prescribing information. Additionally, there are no special monitoring or safety considerations outlined for patients with reduced kidney function. Healthcare professionals should continue to assess the overall clinical status of these patients, but the absence of specific recommendations suggests that standard dosing may be appropriate.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of PerioChip (chlorhexidine gluconate). As such, there are no dosage adjustments, special monitoring requirements, or precautions outlined for this population. Clinicians should exercise caution and consider the overall clinical context when prescribing PerioChip to patients with compromised liver function, as individual responses may vary.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

Chlorhexidine gluconate has not been evaluated for carcinogenic potential in connection with the PerioChip.

No evidence of genetic toxicity associated with chlorhexidine gluconate was observed in a comprehensive battery of mutagenicity studies. These studies included an in vitro Ames assay, a chromosome aberration assay conducted in Chinese hamster ovary (CHO) cells, and an in vivo micronucleus assay performed in mice.

Postmarketing Experience

Adverse effects associated with the use of PerioChip were primarily derived from voluntary reports and surveillance programs. Notably, tooth staining and altered taste perception were not reported following its use. In the two pivotal clinical trials, the most frequently observed adverse events included toothache, upper respiratory tract infection, and headache. Toothache was the only adverse reaction that occurred at a significantly higher rate (p = 0.042) in the PerioChip group compared to placebo.

Most instances of oral pain or sensitivity were reported within the first week following the initial chip placement after scaling and root planing (SRP) procedures. These reactions were generally mild to moderate in nature and resolved spontaneously within a few days. Subsequent chip placements at 3 and 6 months were associated with a lower frequency of these reactions.

In total, adverse events occurring in 1% or more of the 225 patients who received PerioChip were documented, as summarized in Table 3. The only dental adverse event reported at a rate of 1% or less in both groups was gingival bleeding. Among the adverse events reported with a frequency of 1% or greater in the PerioChip group from the two five-center U.S. clinical trials, the following were noted:

• All patients with adverse events: 193 (85.8%)

• Toothache: 114 (50.7%)

• Upper respiratory tract infection: 64 (28.4%)

• Headache: 61 (27.1%)

• Sinusitis: 31 (13.8%)

• Influenza-like symptoms: 17 (7.6%)

• Back pain: 15 (6.7%)

• Tooth disorder: 14 (6.2%)

• Bronchitis: 14 (6.2%)

• Abscess: 13 (5.8%)

• Pain: 11 (4.9%)

• Allergy: 9 (4.0%)

• Myalgia: 9 (4.0%)

• Gum hyperplasia: 8 (3.6%)

• Pharyngitis: 8 (3.6%)

• Arthralgia: 7 (3.1%)

• Dysmenorrhea: 7 (3.1%)

• Dyspepsia: 7 (3.1%)

• Rhinitis: 6 (2.7%)

• Coughing: 6 (2.7%)

• Arthrosis: 6 (2.7%)

• Hypertension: 5 (2.2%)

• Stomatitis ulcerative: 5 (2.2%)

• Tendinitis: 5 (2.2%)

These findings reflect the adverse events reported in the clinical trials without regard to causality.

Patient Counseling

Patients should be advised to avoid using dental floss at the site of PerioChip insertion for 10 days following placement, as flossing may dislodge the chip. They may continue all other oral hygiene practices as usual without any restrictions.

While there are no dietary restrictions associated with the use of PerioChip, patients should be informed that dislodging of the chip is uncommon. However, if the PerioChip does become dislodged, patients should notify their dentist promptly.

Additionally, patients may experience mild to moderate sensitivity during the first week after placement of the PerioChip. It is important for patients to understand that they should contact their dentist immediately if they experience any pain, swelling, or other concerning symptoms.

Storage and Handling

The product is supplied in aluminum blister packs, with each chip individually packed in a separate compartment. It is essential to store the product at a controlled room temperature between 15° and 25°C (59° and 77°F), in accordance with USP guidelines. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Periochip as submitted by Adrian Pharmaceuticals, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)