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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03195582
Other study ID # 0480-16-RMB
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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