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

Primary Purpose

Peri-implantitis

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Chlorhexidine 2.5 mg

Placebo chip

About this trial

This is an interventional treatment trial for Peri-implantitis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
The Oral & Maxillofacial Surgery Unit of the Tel Aviv Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chlorhexidine chip (Periochip®)

Placebo chip

Arm Description

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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT01079663

First Posted

March 2, 2010

Last Updated

May 20, 2021

Sponsor

Dexcel Pharma Technologies Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01079663

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dexcel Pharma Technologies Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peri-implantitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chlorhexidine chip (Periochip®)

Arm Type

Experimental

Arm Description

Arm Title

Placebo chip

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Chlorhexidine 2.5 mg

Intervention Type

Drug

Intervention Name(s)

Placebo chip

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to Week 24

Secondary Outcome Measure Information:

Title

Clinical Attachment Levels (CAL)

Description

Time Frame

Baseline to Week 24

Title

Bleeding on Probing (BOP)

Description

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

Time Frame

Baseline to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

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

City

Haifa

Country

Israel

Facility Name

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

City

Tel Aviv

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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