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

NCT03195582 | Unknown Phase 1

• 1 other identifier: 0480-16-RMB
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Implant Infection; Bone Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PROBING DEPTH

  3 MONTHS

• Width of the keratinized mucosa (WKM)

  3 MONTHS

Study Arms (2)

Test group

EXPERIMENTAL

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

CONTROL group

NO INTERVENTION

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

Interventions

Corsodyl 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.

Also known as: Test group

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are willing to participate and willing to provide an informed consent.
• Males and females between the ages 18-80
• In good general health.
• 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).

You may not qualify if:

• Uncontrolled Type 1 or type 2 diabetes patients( HbA1C\>7).
• 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).
• Patients who underwent guided bone regeneration during implant placement.
• Patients who used antibiotic during the study or 4 weeks prior to the baseline.
• Active periodontitis patients.
• Subjects with presence of active systemic infectious diseases such as: Hepatitis, HIV, history of tuberculosis.
• Pregnant or lactating females.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Hadar Zigdon, Dr.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadar Zigdon, Dr.

CONTACT

972-544545477; h_zigdon@rambam.health.gov.il

Thabet Asbi, Dr.

CONTACT

972-504449658; asbi_thabet@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share