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

Rambam Health Care Campus

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Implant Infection; Bone Loss

Treatments: Drug: Corsodyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03195582

0480-16-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Test group

Experimental group

Description:

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

Treatment:

Drug: Corsodyl

CONTROL group

No Intervention group

Description:

following local anesthesia buccal and lingual flaps will be raised minimally, the cover screw will be removed from the implant .In the control group, Corsodyl gel 1% Chlorohexidine will not 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