Controlled Type 2 Diabetic Patients With PeriodontitisNCT07753317
Clinical and Radiographic Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to MINST of Intrabony Defects in Controlled Type 2 DM
A study testing All participants will receive MINST in people with Controlled Type 2 Diabetic Patients With Periodontitis, run by Cairo University.
Trial summary
The present randomized placebo-controlled trial aims to evaluate and compare the clinical and radiographic efficacy of subgingivally delivered 0.05% zoledronate gel and 1% metformin gel as adjuncts to minimally invasive nonsurgical treatment of intrabony defects in patients with controlled type 2 diabetes mellitus and… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Controlled Type 2 Diabetic Patients With Periodontitis
- What is being tested?
- All participants will receive MINST
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus, with HbA1c levels <7.0% (controlled).
- Diagnosis of chronic periodontitis (Stage III/IV, Grade B/C) with at least one intrabony defect of ≥3 mm depth, PPD ≥5 mm, and CAL ≥4 mm measured with a calibrated UNC-15 probe.
- Angular bone loss of ≥3 mm measured on digital intraoral periapical radiographs and having three walled intrabony defects without involving furcation confirmed on cone beam computed tomography (CBCT).
Who cannot join
- Smokers.
- Pregnant or lactating women.
- Patients on systemic bisphosphonate therapy or other medications known to affect bone metabolism.
- Uncontrolled diabetes (HbA1c >8%) or other systemic diseases that could affect periodontal status.
- History of radiation therapy to the head and neck
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Radiographic Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to Minimally Invasive Nonsurgical Treatment of Intrabony Defects in Controlled Type 2 Diabetic Patients With Periodontitis. A Placebo Randomized Controlled Trial.
The present randomized placebo-controlled trial aims to evaluate and compare the clinical and radiographic efficacy of subgingivally delivered 0.05% zoledronate gel and 1% metformin gel as adjuncts to minimally invasive nonsurgical treatment of intrabony defects in patients with controlled type 2 diabetes mellitus and periodontitis.
- Being tested
- All participants will receive MINST
- Keywords
- Metformin gel, Zoledronate gel, nonsurgical treatment, Intrabony Defects, type 2 diabetes, Periodontitis
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All participants will receive MINSTProcedure or surgery
using ultrasonic scalers and hand curettes over two sessions within 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Subgingival administration of 0.05% zoledronate gel | Active comparator | MINST will be performed followed by Subgingival administration of 0.05% zoledronate gel Receives: Procedure: All participants will receive MINST |
| Subgingival administration of 1% metformin gel | Active comparator | MINST will be performed followed by Subgingival administration of 1% metformin gel Receives: Procedure: All participants will receive MINST |
| Subgingival administration of placebo gel | Placebo comparator | MINST will be performed followed by Subgingival administration of placebo gel Receives: Procedure: All participants will receive MINST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic intra-bony defect depth
The radiographic IBD depth will be measured by computer-aided software program, IBD depth will be measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect
Measured: 6 months
Secondary outcomes (2)
Clinical attachment level
measured from the cementoenamel junction (CEJ) to the bottom of pocket.
Measured: 6 months
Periodontal pocket depth (PPD)
will be recorded from the gingival margin to the base of the pocket
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 posted7 Aug 2026
- Study start7 Aug 2026 (estimated)
- Primary completion7 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Controlled Type 2 Diabetic Patients With PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Egyptian Russian University
- Responsible party
- Principal investigator, Parryhan Mohamed Abdelsamie, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753317
- Sponsor's protocol ID
- MTIERU
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to Minimally Invasive Nonsurgical Treatment of Intrabony Defects in Controlled Type 2 Diabetic Patients With Periodontitis. A Placebo Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07753317
- Acronym / sponsor ID
- MTIERU
- Keywords
- Metformin gel, Zoledronate gel, nonsurgical treatment, Intrabony Defects, type 2 diabetes, Periodontitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Egyptian Russian University
- Study start
- 7 Aug 2026 (estimated)
- Primary completion
- 7 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 7 Aug 2026 (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 present randomized placebo-controlled trial aims to evaluate and compare the clinical and radiographic efficacy of subgingivally delivered 0.05% zoledronate gel and 1% metformin gel as adjuncts to minimally invasive nonsurgical treatment of intrabony defects in patients with controlled type 2 diabetes mellitus and periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subgingival administration of 0.05% zoledronate gel | Active comparator | Procedure: All participants will receive MINSTMINST will be performed followed by Subgingival administration of 0.05% zoledronate gel |
| Subgingival administration of 1% metformin gel | Active comparator | Procedure: All participants will receive MINSTMINST will be performed followed by Subgingival administration of 1% metformin gel |
| Subgingival administration of placebo gel | Placebo comparator | Procedure: All participants will receive MINSTMINST will be performed followed by Subgingival administration of placebo gel |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with type 2 diabetes mellitus, with HbA1c levels <7.0% (controlled).
- Diagnosis of chronic periodontitis (Stage III/IV, Grade B/C) with at least one intrabony defect of ≥3 mm depth, PPD ≥5 mm, and CAL ≥4 mm measured with a calibrated UNC-15 probe.
- Angular bone loss of ≥3 mm measured on digital intraoral periapical radiographs and having three walled intrabony defects without involving furcation confirmed on cone beam computed tomography (CBCT).
Key exclusion criteria (5 listed)
- Smokers.
- Pregnant or lactating women.
- Patients on systemic bisphosphonate therapy or other medications known to affect bone metabolism.
- Uncontrolled diabetes (HbA1c >8%) or other systemic diseases that could affect periodontal status.
- History of radiation therapy to the head and neck
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 |
|---|---|---|
| All participants will receive MINSTusing ultrasonic scalers and hand curettes over two sessions within 1 week. | Procedure or surgery | Subgingival administration of 0.05% zoledronate gel, Subgingival administration of 1% metformin gel, Subgingival administration of placebo gel |
Primary outcome
Radiographic intra-bony defect depth
Time frame: 6 months
The radiographic IBD depth will be measured by computer-aided software program, IBD depth will be measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect
2 secondary outcomes
Clinical attachment level
Time frame: 6 months
Periodontal pocket depth (PPD)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
Related trials for Controlled Type 2 Diabetic Patients With Periodontitis
RecruitingEarly Phase 1
Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
Periodontitis, Diabetes Mellitus Type 2
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.
Questions about this trial
What is this clinical trial studying?
A study testing All participants will receive MINST in people with Controlled Type 2 Diabetic Patients With Periodontitis, run by Cairo 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 3 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: opening soon, as of the sponsor's last update on 11 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Parryhan M Abdelsamie (01003082353, Parryhan.abdelsamie@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic intra-bony defect depth (time frame: 6 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 11 Aug 2026.