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

NCT ID: NCT03195582

Last Updated: 2017-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Implant Infection Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 CHX gel or any other gel.
2. Test group: following implant exposure this group will receive CHX 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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The study will be single blinded. The examiners of the clinical measurements, ELISA samples and the radiographs will be blinded to the patient's group.

Study Groups

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Test group

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

Group Type EXPERIMENTAL

Corsodyl

Intervention Type DRUG

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.

CONTROL group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Test group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Hadar Zigdon MD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hadar Zigdon, Dr.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Central Contacts

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Hadar Zigdon, Dr.

Role: CONTACT

972-544545477

Thabet Asbi, Dr.

Role: CONTACT

972-504449658

Other Identifiers

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0480-16-RMB

Identifier Type: -

Identifier Source: org_study_id

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