PeriodontitisNCT06204185
Clinical and Biochemical Evaluation of 1% Metformin in Non-surgical Treatment of Periodontitis
A study testing Metformin in people with Periodontitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study to evaluate the clinical and biochemical efficacy of 1% Metformin gel in treatment of periodontitis patients Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 30 Nov 2022
- Phase
- Interventional
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with Stage III Grade A Periodontitis.
- Systemically free according to the modified Burkitt's health history questionnaire, Group I. (Glick et al., 2021).
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program.
Who cannot join
- Smokers
- Pregnant and lactating females.
- Vulnerable groups of patients' e.g (prisoners, handicapped patients and decisionally impaired individuals).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Biochemical Evaluation of the Use of Locally Delivered Metformin as an Adjunctive Therapy to Non Surgical Periodontal Treatment of Periodontitis Patients (Randomized Controlled Study)
The aim of the study to evaluate the clinical and biochemical efficacy of 1% Metformin gel in treatment of periodontitis patients
- Conditions
- Periodontitis
- Being tested
- Metformin, Placebo
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Locally delivered Metformin gel in the treatment of periodontitis patients
PlaceboDrug
Placebo gel consist of drug without the active component.
| Study group | Role | What they receive |
|---|---|---|
| 1% Metformin | Active comparator | 1% Metformin Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months. Receives: Drug: Metformin |
| Control Group | Placebo comparator | Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
RANKL and Osteoprotegrin levels in Gingival Crevicular Fluid before & after application of metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
Measured: Baseline and 1 month after the gel application
Secondary outcomes (4)
Plaque index (PI)
Measured: Baseline, 3 Months and 6 Months post operatively.
Gingival Index (GI)
Measured: Baseline, 3 Months and 6 Months post operatively.
Probing depth (PD)
Measured: Baseline, 3 Months and 6 Months post operatively.
Clinical attachment level (CAL)
Measured: Baseline, 3 Months and 6 Months post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Feb 2019
- Primary completion1 Jun 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluate the clinical parameters ( Probing Depth, Clinical Attachment Level, Gingival and Plaque Indices) before \& after the application of locally delivered metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Mohamed Magdy Abou El-Kheir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204185
- Sponsor's protocol ID
- FD-ASUREC.IM011967
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of the Use of Locally Delivered Metformin as an Adjunctive Therapy to Non Surgical Periodontal Treatment of Periodontitis Patients (Randomized Controlled Study)
- ClinicalTrials.gov ID
- NCT06204185
- Acronym / sponsor ID
- FD-ASUREC.IM011967
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 12 Jan 2024 (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 the study to evaluate the clinical and biochemical efficacy of 1% Metformin gel in treatment of periodontitis patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Evaluate the clinical parameters ( Probing Depth, Clinical Attachment Level, Gingival and Plaque Indices) before \& after the application of locally delivered metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
| Arm | Type | Receives |
|---|---|---|
| 1% Metformin | Active comparator | Drug: Metformin1% Metformin Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months. |
| Control Group | Placebo comparator | Drug: PlaceboPlacebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with Stage III Grade A Periodontitis.
- Systemically free according to the modified Burkitt's health history questionnaire, Group I. (Glick et al., 2021).
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program.
Key exclusion criteria (3 listed)
- Smokers
- Pregnant and lactating females.
- Vulnerable groups of patients' e.g (prisoners, handicapped patients and decisionally impaired individuals).
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 |
|---|---|---|
| MetforminLocally delivered Metformin gel in the treatment of periodontitis patients | Drug | 1% Metformin |
| PlaceboPlacebo gel consist of drug without the active component. | Drug | Control Group |
Primary outcome
RANKL and Osteoprotegrin levels in Gingival Crevicular Fluid before & after application of metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
Time frame: Baseline and 1 month after the gel application
4 secondary outcomes
Plaque index (PI)
Time frame: Baseline, 3 Months and 6 Months post operatively.
Gingival Index (GI)
Time frame: Baseline, 3 Months and 6 Months post operatively.
Probing depth (PD)
Time frame: Baseline, 3 Months and 6 Months post operatively.
Clinical attachment level (CAL)
Time frame: Baseline, 3 Months and 6 Months post operatively.
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 12 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Periodontitis, run by Ain Shams University at 1 site in Egypt.
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 3 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
RANKL and Osteoprotegrin levels in Gingival Crevicular Fluid before & after application of metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis. (time frame: Baseline and 1 month after the gel application). 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 12 Jan 2024.