The Effect of Chlorohexidine Gel on Tissue Healing Following Surgical Exposure of Dental Implants

Phase 1

• Conditions: Implant Infection; Bone Loss
• Interventions: Drug: Corsodyl

• Registration Number: NCT03195582
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

The aim of this study is to evaluate the healing of peri-implat tissue following surgical uncovering with the adjunctive use of Chlorohexidine (CHX) gel.

Detailed Description

Patients who received implants in our department, and scheduled for surgical uncovering of the implants will be asked to participate in this clinical trial (40) Patients from Department of periodontology, Rambam Health campus, Haifa in Israel will be recruited to Randomized clinical trial; patients will be divided randomly in to 2 groups:

1. Control: following uncovering of the implant a 4 mm height healing abutment will be screwed to the implant (the standard treatment modality) without using Chlorohexidine gel or any other gel.

2. Test group: following implant exposure this group will receive Chlorohexidine 1% gel (Corsodyl®) the gel will be applied on the abutment as well as on the implant internal hex and then a 4 mm healing abutment will be connected.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-06-21
• Study First Posted: 2017-06-22
• Last Update Posted: 2017-06-22
• Study Start: 2017-08
• Primary Completion: 2018-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients who are willing to participate and willing to provide an informed consent.
2. Males and females between the ages 18-80
3. In good general health.
4. Patients who received dental implants and require implant uncovering (if there is more than 1 implant, a minimum radiographic distance of 3 mm will be required between implants).

Exclusion Criteria

1. Uncontrolled Type 1 or type 2 diabetes patients( HbA1C>7).
2. Subjects treated for at least 2 weeks with any medication known to affect soft tissue condition within one month prior to baseline examination (e.g., Phenytoin, Cyclosporine, and chronic use of Bisphosphonates).
3. Patients who underwent guided bone regeneration during implant placement.
4. Patients who used antibiotic during the study or 4 weeks prior to the baseline.
5. Active periodontitis patients.
6. Subjects with presence of active systemic infectious diseases such as: Hepatitis, HIV, history of tuberculosis.
7. Pregnant or lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Corsodyl	following local anesthesia buccal and lingual flaps will be raised minimally, the cover screw will be removed from the implant .In the test group, Corsodyl gel 1% Chlorohexidine will be applied on the implant and the healing abutment. Healing abutment of 4 mm height will be screwed to the implant and flap will be sutured with silk 4-0 sutures. Parallel radiograph will be taken after the surgery

Primary Outcome Measures

Name	Time	Method
Recession depth	3 MONTHS	Distance from the healing abutment top to the free gingival margin will be measured by periodontal probe at the mid-buccal aspect of the healing abutment. Recession (Rec) is defined as the difference in millimeters between baseline to to 3 months .

Secondary Outcome Measures

Name	Time	Method
PROBING DEPTH	3 MONTHS	The distance between the free gingival margin to the base of the pocket will be measured by periodontal probe in millimeters.
Width of the keratinized mucosa (WKM)	3 MONTHS	the distance in millimeters between the free gingival margin to the mucogingival line will be measured by periodontal probe .