Implant InfectionPhase 1/2NCT03195582
The Effect of Chlorohexidine Gel on Tissue Healing Following Surgical Exposure of Dental Implants
A Phase 1/2 study testing Corsodyl in people with Implant Infection and Bone Loss, run by Rambam Health Care Campus.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Infection, Bone Loss
- What is being tested?
- Corsodyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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:
- 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.
- 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
- Implant Infection, Bone Loss
- Being tested
- Corsodyl
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorsodylDrug
Also called 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% CLOROHEXIDINE will be applied on the implant and the healing abutment.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 3 MONTHS
Secondary outcomes (2)
PROBING DEPTH
The distance between the free gingival margin to the base of the pocket will be measured by periodontal probe in millimeters.
Measured: 3 MONTHS
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 .
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startAug 2017 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadar Zigdon MD, Rambam Health Care Campus
- Investigators
- Hadar Zigdon, Dr., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195582
- Sponsor's protocol ID
- 0480-16-RMB
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chlorohexidine Gel on Tissue Healing Following Surgical Exposure of Dental Implants
- ClinicalTrials.gov ID
- NCT03195582
- Acronym / sponsor ID
- 0480-16-RMB
- Conditions
- Implant Infection, Bone Loss
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Corsodylfollowing 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorsodylAlso: Test groupfollowing 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. | Drug | Test group |
Primary outcome
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 .
2 secondary outcomes
PROBING DEPTH
Time frame: 3 MONTHS
Width of the keratinized mucosa (WKM)
Time frame: 3 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Implant Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Prosthetic Joint Infection of Knee
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Arthroplasty, Arthroplasty Replacement, Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Zigdon, Dr. principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Corsodyl in people with Implant Infection and Bone Loss, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadar Zigdon, Dr. (972-544545477, h_zigdon@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession depth (time frame: 3 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.