Peri-ImplantitisPhase 4NCT03312582
Locally Delivered 1% Metformin Gel in Peri-implantitis
A Phase 4 study testing 1% local metformin gel in people with Peri-Implantitis, run by King Saud University.
Trial summary
This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel with manual debridement while the other half will receive a placebo with manual debridement. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- 1% local metformin gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2015to 24 Jul 2017
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus patients.
- Patients with peri-implantitis
Who cannot join
- History of any other systemic diseases
- Cigarette smokers
- Smokeless tobacco users
- Patients who underwent scaling in the last 1 year
- Patients who took antibiotics in tje past 6 months
About this study
Official title: Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial
This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel with manual debridement while the other half will receive a placebo with manual debridement.
Read the detailed description
Metformin is an oral hypoglycemic drug categorized under biguanide and are considered the most efficient agents widely used in the treatment of type 2 diabetes mellitus.The general clinical benefits observed in therapy with MF seem to be greater than expected. They induce osteoblast cells to promote early bone formation through AMP kinase (AMPK) activity. Moreover, in a recent in vitro study, MF facilitated in the proliferation of MG63 osteoblast like cells. Thus, their action in stimulating bone formation has justified their use in the treatment of perimplantitis.
- Conditions
- Peri-Implantitis
- Being tested
- 1% local metformin gel, Placebo
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% local metformin gelDrug
After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.
PlaceboProcedure or surgery
Also called After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Manual debridement and 1% metformin gel | Experimental | Not described Receives: Drug: 1% local metformin gel |
| Manual debridement and placebo | Placebo comparator | Not described Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.
Measured: 6 months
Peri-implant prpbing depth
Will be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start15 Mar 2015
- Primary completion14 Aug 2016
- Study completion24 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohaib Akram, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312582
- Sponsor's protocol ID
- FR-17-75
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Locally Delivered 1% Metformin Gel in the Treatment of Peri-implantitis in Type2 Diabetes Mellitus Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03312582
- Acronym / sponsor ID
- FR-17-75
- Conditions
- Peri-Implantitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 15 Mar 2015 (actual)
- Primary completion
- 14 Aug 2016 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 17 Oct 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.
This study evaluates the efficacy of 1% local metformin gel in deep periimplant pockets of type 2 diabetes mellitus patients. Half of the participants will receive 1% metformin gel with manual debridement while the other half will receive a placebo with manual debridement.
Detailed description
Metformin is an oral hypoglycemic drug categorized under biguanide and are considered the most efficient agents widely used in the treatment of type 2 diabetes mellitus.The general clinical benefits observed in therapy with MF seem to be greater than expected. They induce osteoblast cells to promote early bone formation through AMP kinase (AMPK) activity. Moreover, in a recent in vitro study, MF facilitated in the proliferation of MG63 osteoblast like cells. Thus, their action in stimulating bone formation has justified their use in the treatment of perimplantitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual debridement and 1% metformin gel | Experimental | Drug: 1% local metformin gel |
| Manual debridement and placebo | Placebo comparator | Procedure: Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes mellitus patients.
- Patients with peri-implantitis
Key exclusion criteria (5 listed)
- History of any other systemic diseases
- Cigarette smokers
- Smokeless tobacco users
- Patients who underwent scaling in the last 1 year
- Patients who took antibiotics in tje past 6 months
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 |
|---|---|---|
| 1% local metformin gelAfter providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied. | Drug | Manual debridement and 1% metformin gel |
| PlaceboAlso: After providing manual debridement in deep peri-implant probing depths, placebo gel will be applied. | Procedure or surgery | Manual debridement and placebo |
Primary outcome
Marginal bone loss
Time frame: 6 months
Marginal bone loss will be assessed on digital radiographs on calibrated computer screen.
Peri-implant prpbing depth
Time frame: 6 months
Will be measured with UNC-15 periodontal probe from crest of the gingival margin to the base of the peri-implant probing depth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1% local metformin gel in people with Peri-Implantitis, run by King Saud University.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 17 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss (time frame: 6 months). The study lists 2 primary outcomes in all. 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 17 Oct 2017.