CClinicalTrials.gg
Status unknownNCT03195582Updated Jun 22, 2017

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

A Phase 1/2 interventional study of Corsodyl in Implant Infection and Bone Loss, sponsored by Rambam Health Care Campus. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-22.

Sponsored by Rambam Health Care Campus · Phase 1/2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Implant Infection
  • Bone Loss
03

In context

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugCorsodyl

    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

06

What researchers measure

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 .

    Time frame: 3 MONTHS

Secondary outcomes

  1. PROBING DEPTH

    The distance between the free gingival margin to the base of the pocket will be measured by periodontal probe in millimeters.

    Time frame: 3 MONTHS

  2. 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 .

    Time frame: 3 MONTHS

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03195582
Lead sponsor
Rambam Health Care Campus
Responsible party
Hadar Zigdon MD (Dr., Rambam Health Care Campus) — Principal investigator
First posted
Jun 22, 2017
Start date
Aug 2017 (estimated)
Primary completion
Aug 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jun 22, 2017

Study contacts

Hadar Zigdon, Dr.
Contact
h_zigdon@rambam.health.gov.il
972-544545477
Thabet Asbi, Dr.
Contact
asbi_thabet@hotmail.com
972-504449658
Hadar Zigdon, Dr.
principal investigator · Rambam Health Care Campus

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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