The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis

Phase 2

Completed

• Conditions: Peri-implantitis
• Interventions: Drug: Chlorhexidine 2.5 mg; Drug: Placebo chip

• Registration Number: NCT01079663
• Lead Sponsor: Dexcel Pharma Technologies Ltd.

Brief Summary

The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.

Detailed Description

This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Results First Submitted: 2021-04-29
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Results First Posted: 2021-06-15
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Signed and dated Informed Consent Form.
2. Good general health.
3. Male or female patients aged >21 years old.
4. Availability for the 25 week duration of the study.
5. Peri-implantitis is characterized by the presence of at least 1 implant with periodontal pockets of 6-10 mm in depth (potential target implant) demonstrating Bleeding on Probing without involving the apex of the implant and confirmed radiographically.
6. Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.

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Exclusion Criteria

1. Presence of oral local mechanical factors that could (in the opinion of the Investigator) influence the outcome of the study.
2. Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.
3. Presence of soft or hard tissue tumours of the oral cavity.
4. Horizontal inter implant distance ≤2 mm (if an adjacent implant exists).
5. Selection of the following dental implant types as target implant/s: hydroxylapatite (HA) and/or Titanium Plasma-sprayed (TPS).
6. History of allergy to Chlorhexidine.
7. Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
8. Patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration (excluding treatment of acetylsalicylic acid ≤100 mg /day).
9. Patients taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
10. Presence of any of the following conditions: Type 1 diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
11. The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
12. Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
13. Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine chip (Periochip®)	Chlorhexidine 2.5 mg	PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate PerioChips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm
Placebo chip	Placebo chip	Placebo Chip Placebo Chips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm

Primary Outcome Measures

Name	Time	Method
Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket	Baseline to Week 24	Pocket depth is the measurement of the distance from the coronal edge of the gingival margin to the base of the pocket. Measurements were taken with a standard 15-mm University of North Carolina (UNC) periodontal probe.; Change from baseline in PPD was calculated as Week 24 PPD minus Baseline PPD such that a negative difference indicates an improvement in condition

Secondary Outcome Measures

Name	Time	Method
Clinical Attachment Levels (CAL)	Baseline to Week 24	Loss of attachment is defined as the distance in millimetres that the base of the pocket has migrated apically from the gingival margin of the crown. CAL was calculated at the same site that PPD was measured
Bleeding on Probing (BOP)	Baseline to Week 24	BOP was measured at the same site after measuring the PPD. The scoring system used for recording the BOP was a dichotomous one: 0 = No bleeding; 1 = Bleeding on probing of the pocket base

Trial Locations

Locations (2)

Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center; 🇮🇱 Haifa, Israel

The Oral & Maxillofacial Surgery Unit of the Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel