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

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ClinicalTrials.gov Identifier: NCT03195582
Recruitment Status : Unknown
Verified June 2017 by Hadar Zigdon MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Hadar Zigdon MD, 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.

Condition or disease Intervention/treatment Phase
Implant Infection Bone Loss Drug: Corsodyl Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: The Effect of Chlorohexidine Gel on Tissue Healing Following Surgical Exposure of Dental Implants
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: 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

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.
Other Name: Test group

No Intervention: 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




Primary Outcome Measures :
  1. Recession depth [ Time Frame: 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 :
  1. PROBING DEPTH [ Time Frame: 3 MONTHS ]
    The distance between the free gingival margin to the base of the pocket will be measured by periodontal probe in millimeters.

  2. Width of the keratinized mucosa (WKM) [ Time Frame: 3 MONTHS ]
    the distance in millimeters between the free gingival margin to the mucogingival line will be measured by periodontal probe .



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195582


Contacts
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Contact: Hadar Zigdon, Dr. 972-544545477 h_zigdon@rambam.health.gov.il
Contact: Thabet Asbi, Dr. 972-504449658 asbi_thabet@hotmail.com

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Hadar Zigdon, Dr. Rambam Health Care Campus

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Responsible Party: Hadar Zigdon MD, Dr., Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03195582     History of Changes
Other Study ID Numbers: 0480-16-RMB
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents