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

Peri-implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079663
• Other study ID #: CLI/013P
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: November 2011

Study information

• Verified date: May 2021
• Source: Dexcel Pharma Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Peri-implantitis

Intervention

Drug:
• Chlorhexidine 2.5 mg

• Placebo chip

Locations

Country	Name	City	State
Israel	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

Sponsors (1)

Lead Sponsor	Collaborator
Dexcel Pharma Technologies Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Attachment Levels (CAL)	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	Baseline to Week 24
Secondary	Bleeding on Probing (BOP)	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	Baseline to Week 24