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

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03195582
• Other study ID #: 0480-16-RMB
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: June 20, 2017
• Last updated: June 21, 2017
• Start date: August 2017
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Rambam Health Care Campus
• Contact: Hadar Zigdon, Dr.
• Phone: 972-544545477
• Email: h_zigdon[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss
• Implant Infection

Intervention

Drug:
• 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% CLOROHEXIDINE will be applied on the implant and the healing abutment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession depth	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 .	3 MONTHS
Secondary	PROBING DEPTH	The distance between the free gingival margin to the base of the pocket will be measured by periodontal probe in millimeters.	3 MONTHS
Secondary	Width of the keratinized mucosa (WKM)	the distance in millimeters between the free gingival margin to the mucogingival line will be measured by periodontal probe .	3 MONTHS