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

NCT01079663 | Completed Phase 2 Results

• 1 other identifier: CLI/013P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Peri-implantitis

Outcome Measures

Primary Outcomes (1)

• Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket

  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

  Baseline to Week 24

Secondary Outcomes (2)

• Clinical Attachment Levels (CAL)

  Baseline to Week 24

• Bleeding on Probing (BOP)

  Baseline to Week 24

Study Arms (2)

Chlorhexidine chip (Periochip®)

EXPERIMENTAL

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

Drug: Chlorhexidine 2.5 mg

Placebo chip

PLACEBO COMPARATOR

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

Drug: Placebo chip

Interventions

Chlorhexidine 2.5 mg DRUG

Chlorhexidine chip (Periochip®)

Placebo chip DRUG

Placebo chip

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated Informed Consent Form.
• Good general health.
• Male or female patients aged \>21 years old.
• Availability for the 25 week duration of the study.
• 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.
• 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.

You may not qualify if:

• Presence of oral local mechanical factors that could (in the opinion of the Investigator) influence the outcome of the study.
• Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.
• Presence of soft or hard tissue tumours of the oral cavity.
• Horizontal inter implant distance ≤2 mm (if an adjacent implant exists).
• Selection of the following dental implant types as target implant/s: hydroxylapatite (HA) and/or Titanium Plasma-sprayed (TPS).
• History of allergy to Chlorhexidine.
• Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
• 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).
• Patients taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
• Presence of any of the following conditions: Type 1 diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
• 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.
• Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
• Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.

Sponsors & Collaborators

• Dexcel Pharma Technologies Ltd.: lead

Study Sites (2)

Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center

Haifa, Israel

Location

The Oral & Maxillofacial Surgery Unit of the Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Clinical Trial Department Manager
• Organization: Dexcel Pharma

sigalit.melcer@dexcel.com

972-4-6364000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

IL (2)