Stage II, Grade B PeriodontitisMET-CHX PerioNCT07215156
Metformin Versus Chlorhexidine Gel as Adjuncts to Scaling and Root Planing in Stage II Grade B Periodontitis
A study testing Arm 1 Scaling and Root Planing (SRP), Arm 2 Metformin Gel 1% (locally delivered) and Arm 3 Chlorhexidine Gel 0.2% (locally delivered) in people with Stage II, Grade B Periodontitis and Chronic Periodontitis, run by Kafrelsheikh University.
Trial summary
This clinical trial is designed to evaluate two locally delivered gels, metformin and chlorhexidine, as adjunctive therapies to scaling and root planing (SRP) in patients with Stage II, Grade B periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting tissues of the teeth. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stage II, Grade B Periodontitis, Chronic Periodontitis
- What is being tested?
- Arm 1 Scaling and Root Planing (SRP), Arm 2 Metformin Gel 1% (locally delivered) and Arm 3 Chlorhexidine Gel 0.2% (locally delivered)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2025to 1 Jun 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years.
- Diagnosis of Stage II, Grade B periodontitis.
- Probing pocket depths ≤ 5 mm with clinical attachment loss of 3-4 mm in selected sites.
- Generally healthy individuals without systemic conditions affecting periodontal health.
Who cannot join
- Current smokers or users of tobacco products.
- Pregnant or lactating women.
- Known allergy to metformin or chlorhexidine.
- Use of antibiotics or anti-inflammatory drugs within the past 3 months.
- History of periodontal therapy within the past 6 months.
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: Comparative Study Between Metformin and Chlorhexidine Gel as Adjunctive to Conventional Non-Surgical Treatment of Stage II Grade B Periodontitis: A Randomized Controlled Clinical Trial
This clinical trial is designed to evaluate two locally delivered gels, metformin and chlorhexidine, as adjunctive therapies to scaling and root planing (SRP) in patients with Stage II, Grade B periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting tissues of the teeth. Although SRP is the standard non-surgical treatment, it may not fully eliminate harmful bacteria or prevent disease recurrence.
Chlorhexidine is a widely used antimicrobial gel, while metformin, a medication commonly prescribed for diabetes, has shown anti-inflammatory and bone-supportive effects when used locally in the gums. This study will directly compare the effectiveness of 1% metformin gel and 0.2% chlorhexidine gel, both applied subgingivally after SRP, against SRP alone.
Read more
Sixty adult participants diagnosed with Stage II, Grade B periodontitis will be randomly assigned into three groups: SRP only (control), SRP plus metformin gel, and SRP plus chlorhexidine gel. Clinical outcomes (plaque index, gingival index, probing pocket depth, and clinical attachment level), inflammatory markers (MMP-8 in gingival crevicular fluid), and radiographic bone density will be measured at baseline, 1 month, 3 months, and 6 months.
The goal is to determine whether metformin gel or chlorhexidine gel provides superior improvements in periodontal healing when compared with SRP alone. Findings from this trial may guide evidence-based decisions on optimizing non-surgical periodontal therapy.
Read the detailed description
This is a randomized, controlled, single-blind clinical trial conducted at the Department of Oral Medicine, Periodontology, Oral Diagnosis, and Oral Radiology, Faculty of Dentistry, Kafrelsheikh University, Egypt. Sixty participants aged 18-60 years with Stage II, Grade B periodontitis will be enrolled. Participants will be randomly allocated (1:1:1) into three groups:
Group A (Control): SRP only
Group B (Test 1): SRP + 1% Metformin Gel
Group C (Test 2): SRP + 0.2% Chlorhexidine Gel
Subgingival gels will be applied after SRP using sterile syringes, followed by periodontal pack placement for one week. All patients will receive standardized oral hygiene instructions.
Outcome Measures:
Primary Outcomes: Clinical attachment level (CAL) changes, reduction in inflammatory markers (MMP-8), and radiographic bone density gain.
Secondary Outcomes: Probing pocket depth (PPD), plaque index (PI), and gingival index (GI).
Follow-up assessments will be performed at 1, 3, and 6 months. Data will be statistically analyzed using ANOVA and paired t-tests, with significance at p < 0.05.
The trial has been reviewed and approved by the Scientific Research Ethics Committee, Faculty of Dentistry, Kafrelsheikh University (Approval No. KFSIRB200-564, dated 24 February 2025).
- Being tested
- Arm 1 Scaling and Root Planing (SRP), Arm 2 Metformin Gel 1% (locally delivered), Arm 3 Chlorhexidine Gel 0.2% (locally delivered)
- Keywords
- Periodontitis, Stage II Grade B Periodontitis, Chronic Periodontitis, Scaling and Root Planing (SRP), Non-surgical Periodontal Therapy, Metformin Gel, Chlorhexidine Gel, Local Drug Delivery, Periodontal Regeneration, Inflammatory Markers (MMP-8)
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 Scaling and Root Planing (SRP)Procedure or surgery
Full-mouth supragingival and subgingival debridement performed with ultrasonic and hand instruments (Gracey curettes). SRP performed to remove plaque and calculus and root-surface decontamination. Standardized oral hygiene instruction is provided after the procedure.
Arm 2 Metformin Gel 1% (locally delivered)Drug
1% metformin hydrochloride formulated in a gellan-gum gel base (as per protocol). After SRP, gel is delivered subgingivally with a sterile syringe (23-gauge cannula) and left undisturbed for approximately 5 minutes; a periodontal dressing is placed for one week. Gingival crevicular fluid sampling and clinical follow-up at 1, 3, and 6 months.
Arm 3 Chlorhexidine Gel 0.2% (locally delivered)Drug
0.2% chlorhexidine digluconate gel prepared in carbopol base. After SRP, gel is delivered subgingivally with a sterile syringe and left undisturbed for approximately 5 minutes; a periodontal dressing is placed for one week. Clinical follow-up at 1, 3, and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Control: Scaling and Root Planing (SRP) Only | Active comparator | Participants receive conventional subgingival scaling and root planing (SRP) alone using hand and ultrasonic instruments, plus standardized oral hygiene instruction. No adjunctive local drug or gel is applied. Receives: Procedure: Arm 1 Scaling and Root Planing (SRP) |
| Arm 2 - Experimental: SRP + 1% Metformin Gel | Experimental | Participants receive conventional SRP followed by subgingival application of 1% metformin gel into selected periodontal pockets; a periodontal dressing is placed for one week. Participants receive standardized oral hygiene instruction. Receives: Drug: Arm 2 Metformin Gel 1% (locally delivered) |
| Arm 3 - Experimental: SRP + 0.2% Chlorhexidine Gel | Experimental | Participants receive conventional SRP followed by subgingival application of 0.2% chlorhexidine gel into selected periodontal pockets; a periodontal dressing is placed for one week. Participants receive standardized oral hygiene instruction. Receives: Drug: Arm 3 Chlorhexidine Gel 0.2% (locally delivered) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Crevicular Fluid MMP-8 Levels
Active MMP-8 concentrations will be quantified in gingival crevicular fluid using ELISA. PerioPaper strips will be used for collection. Reduction in MMP-8 indicates decreased periodontal inflammation.
Measured: Baseline, 1 month, and 3 months
Change in Clinical Attachment Level (CAL)
CAL will be measured from the cementoenamel junction to the base of the periodontal pocket using a UNC-15 probe. Improvement in CAL reflects periodontal tissue healing and attachment gain.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Alveolar Bone Density
Standardized periapical digital radiographs will be analyzed using Digora software to calculate mean gray-level values in the region of interest (1 mm below CEJ, 7 mm apically). An increase indicates bone density improvement.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (3)
Change in Probing Pocket Depth (PPD)
Probing depth will be measured at six sites per tooth using a UNC-15 probe. Reduction in pocket depth indicates clinical improvement in periodontal status.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Gingival Index (GI) Score
Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Decreased GI score reflects reduction in gingival inflammation.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Plaque Index (PI) Score
Oral hygiene status will be evaluated using the Silness and Löe Plaque Index. Reduction in PI indicates improved plaque control.
Measured: Baseline, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start6 Oct 2025 (estimated)
- Primary completion10 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II, Grade B PeriodontitisStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: SRP alone, SRP + Metformin gel, or SRP + Chlorhexidine gel.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duaa Luwai Osman Hashim, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215156
- Sponsor's protocol ID
- KFSIRB200-564
- Acronym
- MET-CHX Perio
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- 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 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Metformin and Chlorhexidine Gel as Adjunctive to Conventional Non-Surgical Treatment of Stage II Grade B Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07215156
- Acronym / sponsor ID
- MET-CHX Perio / KFSIRB200-564
- Keywords
- Periodontitis, Stage II Grade B Periodontitis, Chronic Periodontitis, Scaling and Root Planing (SRP), Non-surgical Periodontal Therapy, Metformin Gel, Chlorhexidine Gel, Local Drug Delivery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 6 Oct 2025 (estimated)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Oct 2025 (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 clinical trial is designed to evaluate two locally delivered gels, metformin and chlorhexidine, as adjunctive therapies to scaling and root planing (SRP) in patients with Stage II, Grade B periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting tissues of the teeth. Although SRP is the standard non-surgical treatment, it may not fully eliminate harmful bacteria or prevent disease recurrence.
Chlorhexidine is a widely used antimicrobial gel, while metformin, a medication commonly prescribed for diabetes, has shown anti-inflammatory and bone-supportive effects when used locally in the gums. This study will directly compare the effectiveness of 1% metformin gel and 0.2% chlorhexidine gel, both applied subgingivally after SRP, against SRP alone.
Sixty adult participants diagnosed with Stage II, Grade B periodontitis will be randomly assigned into three groups: SRP only (control), SRP plus metformin gel, and SRP plus chlorhexidine gel. Clinical outcomes (plaque index, gingival index, probing pocket depth, and clinical attachment level), inflammatory markers (MMP-8 in gingival crevicular fluid), and radiographic bone density will be measured at baseline, 1 month, 3 months, and 6 months.
The goal is to determine whether metformin gel or chlorhexidine gel provides superior improvements in periodontal healing when compared with SRP alone. Findings from this trial may guide evidence-based decisions on optimizing non-surgical periodontal therapy.
Detailed description
This is a randomized, controlled, single-blind clinical trial conducted at the Department of Oral Medicine, Periodontology, Oral Diagnosis, and Oral Radiology, Faculty of Dentistry, Kafrelsheikh University, Egypt. Sixty participants aged 18-60 years with Stage II, Grade B periodontitis will be enrolled. Participants will be randomly allocated (1:1:1) into three groups:
Group A (Control): SRP only
Group B (Test 1): SRP + 1% Metformin Gel
Group C (Test 2): SRP + 0.2% Chlorhexidine Gel
Subgingival gels will be applied after SRP using sterile syringes, followed by periodontal pack placement for one week. All patients will receive standardized oral hygiene instructions.
Outcome Measures:
Primary Outcomes: Clinical attachment level (CAL) changes, reduction in inflammatory markers (MMP-8), and radiographic bone density gain.
Secondary Outcomes: Probing pocket depth (PPD), plaque index (PI), and gingival index (GI).
Follow-up assessments will be performed at 1, 3, and 6 months. Data will be statistically analyzed using ANOVA and paired t-tests, with significance at p < 0.05.
The trial has been reviewed and approved by the Scientific Research Ethics Committee, Faculty of Dentistry, Kafrelsheikh University (Approval No. KFSIRB200-564, dated 24 February 2025).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: SRP alone, SRP + Metformin gel, or SRP + Chlorhexidine gel.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Control: Scaling and Root Planing (SRP) Only | Active comparator | Procedure: Arm 1 Scaling and Root Planing (SRP)Participants receive conventional subgingival scaling and root planing (SRP) alone using hand and ultrasonic instruments, plus standardized oral hygiene instruction. No adjunctive local drug or gel is applied. |
| Arm 2 - Experimental: SRP + 1% Metformin Gel | Experimental | Drug: Arm 2 Metformin Gel 1% (locally delivered)Participants receive conventional SRP followed by subgingival application of 1% metformin gel into selected periodontal pockets; a periodontal dressing is placed for one week. Participants receive standardized oral hygiene instruction. |
| Arm 3 - Experimental: SRP + 0.2% Chlorhexidine Gel | Experimental | Drug: Arm 3 Chlorhexidine Gel 0.2% (locally delivered)Participants receive conventional SRP followed by subgingival application of 0.2% chlorhexidine gel into selected periodontal pockets; a periodontal dressing is placed for one week. Participants receive standardized oral hygiene instruction. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-60 years.
- Diagnosis of Stage II, Grade B periodontitis.
- Probing pocket depths ≤ 5 mm with clinical attachment loss of 3-4 mm in selected sites.
- Generally healthy individuals without systemic conditions affecting periodontal health.
Key exclusion criteria (5 listed)
- Current smokers or users of tobacco products.
- Pregnant or lactating women.
- Known allergy to metformin or chlorhexidine.
- Use of antibiotics or anti-inflammatory drugs within the past 3 months.
- History of periodontal therapy within the 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 |
|---|---|---|
| Arm 1 Scaling and Root Planing (SRP)Full-mouth supragingival and subgingival debridement performed with ultrasonic and hand instruments (Gracey curettes). SRP performed to remove plaque and calculus and root-surface decontamination. Standardized oral hygiene instruction is provided after the procedure. | Procedure or surgery | Arm 1 - Control: Scaling and Root Planing (SRP) Only |
| Arm 2 Metformin Gel 1% (locally delivered)1% metformin hydrochloride formulated in a gellan-gum gel base (as per protocol). After SRP, gel is delivered subgingivally with a sterile syringe (23-gauge cannula) and left undisturbed for approximately 5 minutes; a periodontal dressing is placed for one week. Gingival crevicular fluid sampling and clinical follow-up at 1, 3, and 6 months. | Drug | Arm 2 - Experimental: SRP + 1% Metformin Gel |
| Arm 3 Chlorhexidine Gel 0.2% (locally delivered)0.2% chlorhexidine digluconate gel prepared in carbopol base. After SRP, gel is delivered subgingivally with a sterile syringe and left undisturbed for approximately 5 minutes; a periodontal dressing is placed for one week. Clinical follow-up at 1, 3, and 6 months. | Drug | Arm 3 - Experimental: SRP + 0.2% Chlorhexidine Gel |
Primary outcome
Change in Gingival Crevicular Fluid MMP-8 Levels
Time frame: Baseline, 1 month, and 3 months
Active MMP-8 concentrations will be quantified in gingival crevicular fluid using ELISA. PerioPaper strips will be used for collection. Reduction in MMP-8 indicates decreased periodontal inflammation.
Change in Clinical Attachment Level (CAL)
Time frame: Baseline, 1 month, 3 months, and 6 months
CAL will be measured from the cementoenamel junction to the base of the periodontal pocket using a UNC-15 probe. Improvement in CAL reflects periodontal tissue healing and attachment gain.
Change in Alveolar Bone Density
Time frame: Baseline, 3 months, and 6 months
Standardized periapical digital radiographs will be analyzed using Digora software to calculate mean gray-level values in the region of interest (1 mm below CEJ, 7 mm apically). An increase indicates bone density improvement.
3 secondary outcomes
Change in Probing Pocket Depth (PPD)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Gingival Index (GI) Score
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Plaque Index (PI) Score
Time frame: Baseline, 1 month, 3 months, and 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 10 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Stage II, Grade B Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Not yet recruiting
Spirulina Gel in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II
Not yet recruiting
Active Oxygen Gel vs Chlorhexidine Gel in Stage II Grade B Periodontitis
Stage II Grade B Periodontitis
Not yet recruiting
Locally Delivered Melatonin Gel in Management of Stage II Grade B Periodontitis
Periodontal Diseases
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 Arm 1 Scaling and Root Planing (SRP), Arm 2 Metformin Gel 1% (locally delivered) and Arm 3 Chlorhexidine Gel 0.2% (locally delivered) in people with Stage II, Grade B Periodontitis and Chronic Periodontitis, run by Kafrelsheikh 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 4 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 10 Oct 2025. 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.
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 Duaa Luwai Hashim, B.D.S (2011) NRU (+20 10 96329474, Doaaloai09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival Crevicular Fluid MMP-8 Levels (time frame: Baseline, 1 month, and 3 months). The study lists 3 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 10 Oct 2025.