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AzTrials

PeriodontitisNCT06027151

Comparing the Efficacy of Metronidazole and Minocycline Gels for the Treatment of Diabetic Periodontitis Patients

A study testing 1ml of 1% metronidazole gel, 1ml of 2% minocycline gel and 1ml of combination of 1% metronidazole gel and 2% minocycline in people with Periodontitis and Diabetes Mellitus, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical study randomized 380 diabetic chronic periodontitis patients into 4 groups: scaling and root planning alone (group I), scaling and root planning plus metronidazole gel (group II), scaling and root planning plus minocycline gel (group III), and scaling and root planning plus both metronidazole and… Read more about this study

Who is it for?
Any age
Conditions the study is for
Periodontitis, Diabetes Mellitus
What is being tested?
1ml of 1% metronidazole gel, 1ml of 2% minocycline gel and 1ml of combination of 1% metronidazole gel and 2% minocycline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
1 sitePakistan
Study dates
6 Oct 2022to 31 Jul 2023
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Previously diagnosed diabetic patients on either hypoglycemics or insulin therapy suffering from periodontitis

Who cannot join

  • Pregnant or nursing mothers Patients with gestational diabetes Alcoholics Patients under any anti-inflammatory or antibiotic drugs (daily for ˃7 consecutive days) within the last two months of elimination before entering the study.
  • Known allergy to minocycline, or metronidazole. Periodontal surgeries in the past Smoking

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Islamic International Medical Collège, IIMC

    Rawalpindi, Punjab Province, 44000

Other trials in Pakistan

About this study

This clinical study randomized 380 diabetic chronic periodontitis patients into 4 groups: scaling and root planning alone (group I), scaling and root planning plus metronidazole gel (group II), scaling and root planning plus minocycline gel (group III), and scaling and root planning plus both metronidazole and minocycline gels (group IV). Periodontal measurements including probing depth, gingival color and texture, bleeding on probing, clinical attachment level, and recession were recorded at baseline, 7 days, and 15 days.

Read the detailed description

It was a clinical trial with four arms. The research was carried out at the Pharmacology Department, IIMC Riphah University, Rawalpindi. The sample size was calculated to be 380 using the prevalence of disease, z-score, and 5% margin of error. Written informed consent was obtained from the participants. The patients being treated for chronic periodontitis were randomly divided into four groups (I, II, III, and IV). Patients in Group I were subjected to Scaling and root planning alone. Group II patients were given metronidazole gel following Scaling and root planning. Minocycline gel was locally applied subsequent to scaling and root planning in Group III patients. The combination of metronidazole gel and minocycline gel was administered after Scaling and root planning in Group IV patients. Scaling and root planning of all the patients was done. Periodontal probing depth, the color of the gingiva, texture of the gingiva, bleeding on probing, clinical attachment level, and recession were recorded for each patient at baseline visit, after 7 days, and after 15 days to determine and compare the efficacy of local administration of drugs.

Being tested
1ml of 1% metronidazole gel, 1ml of 2% minocycline gel, 1ml of combination of 1% metronidazole gel and 2% minocycline
Keywords
Chronic periodontitis, Minocycline gel, Scaling and root planning, Metronidazole gel, Efficacy of local administration, Diabetes mellitus
Medical subject headings
Periodontitis, Diabetes Mellitus, Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1ml of 1% metronidazole gelDrug

    Also called metronidazole

    Subgingivally at baseline visit

  • 1ml of 2% minocycline gelDrug

    Also called minocycline

    sub gingivally at baseline visit

  • 1ml of combination of 1% metronidazole gel and 2% minocyclineDrug

    Also called metronidazole/minocycline

    subgingivally at baseline visit

Study groups in NCT06027151
Study groupRoleWhat they receive
Scaling and root planningNo interventionOnce the patients fulfill the inclusion criteria and are randomly assigned to this group, they undergo scaling and root planning by the consultant. Baseline values are recorded, and patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.
Scaling and root planning plus metronidazole gelExperimentalAfter fulfilling the inclusion criteria and randomly assigning to this group, they undergo scaling and root planning by the consultant. Baseline values are recorded, and 1ml of 1% metronidazole gel is applied subgingivally. The patients are instructed not to spit or rinse for at least one hour. Then patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.
Receives: Drug: 1ml of 1% metronidazole gel
Scaling and root planning plus minocycline gelExperimentalAfter fulfilling the inclusion criteria and being randomly assigned to this group, the patients undergo scaling and root planning by the consultant. Baseline values are recorded, and 1ml of 2% minocycline gel is applied subgingivally. The patients are instructed not to spit or rinse for at least one hour. Then patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.
Receives: Drug: 1ml of 2% minocycline gel
Scaling and root planning plus combination of metronidazole and minocycline gelsExperimentalAfter fulfilling the inclusion criteria and being randomly assigned to this group, the patients undergo scaling and root planning by the consultant. Baseline values are recorded, 1ml of the combination of 1% metronidazole gel and 2% minocycline gel is applied subgingivally. The patients are instructed not to spit or rinse for at least one hour. Then patients are advised oral hygiene instructions i.e., proper brushing and flossing. They are recalled after 7 and 15 days and all clinical parameters are rerecorded.
Receives: Drug: 1ml of combination of 1% metronidazole gel and 2% minocycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PERIODONTAL POCKET DEPTH (PPD)

    Periodontal pocket depth was measured in mm using a WHO (CPITN) periodontal probe.

    Baseline periodontal probing depth was measured before application of drug. It was remeasured on 7th day and 15th day. Reduction in probing depth indicates improvement on follow up visits.

    Measured: 15 days

Secondary outcomes (5)

  1. COLOR OF GINGIVA

    Color of gingiva is observed at baseline visit, on 7th day and 15th day. Healthy gingiva is coral pink in color while diseased gingiva is erythematous cyanotic.

    Measured: 15 days

  2. TEXTURE OF GINGIVA

    Texture of gingiva is observed at baseline visit, on 7th day and 15th day. Healthy gingiva is matte and stippled. Diseased gingiva is smooth and shiny.

    Measured: 15 days

  3. BLEEDING ON PROBING (BOP)

    It was determined whether the site was bleeding on probing or not. Bleeding on probing is observed on the baseline visit, 7th day, and 15th day. If the gingiva is not bleeding then it is considered as normal.

    Measured: 15 days

  4. CLINICAL ATTACHMENT Level

    Distance from cementoenamel junction to depth of pocket is measured with the help of CPITN probe. Readings are taken on baseline visit, 7th day and 15th day. Severity index is as follows.

    Healthy gingiva- 0mm CAL Mild: 1- or 2-mm CAL Moderate: 3- or 4-mm CAL Severe: ≥ 5mm CAL

    Measured: 15 days

  5. RECESIION OF GINGIVAL MARGIN:

    Recession is measured from CEJ to margin of gingiva with the help of CPITN probe on baseline visit, 7th day and 15th day. Severity of disease is assessed as follows

    CLASS I:

    Marginal tissue recession that does not extend to the mucogingival junction. There is no loss of bone or soft tissue in the interdental area. This can be narrow or wide.

    CLASS II:

    Marginal tissue recession that extends to or beyond the mucogingival junction. There is no loss of bone or soft tissue in the interdental area. This can be narrow or wide.

    CLASS III:

    Marginal tissue recession that extends to or beyond the mucogingival junction. In addition, there is loss of bone and/or soft tissue in the interdental area or there is malpositioning of the tooth.

    CLASS IV:

    Marginal tissue recession that extends to or beyond the mucogingival junction with severe loss of bone and soft tissue interdentally and/or severe malpositioning of the tooth.

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2023
  2. Study start6 Oct 2022
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2023

Resources

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
Single blind
Who is masked
Participant
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06027151
Sponsor's protocol ID
Riphah/IIMC/IRC/22/2070
Status last verified
Sep 2025
First submitted
31 Aug 2023
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 1ml of 1% metronidazole gel, 1ml of 2% minocycline gel and 1ml of combination of 1% metronidazole gel and 2% minocycline in people with Periodontitis and Diabetes Mellitus, run by Riphah International University at 1 site in Pakistan.

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 1 inclusion and 2 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 1 Oct 2025. 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 Pakistan. 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. 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?

PERIODONTAL POCKET DEPTH (PPD) (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06027151.

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 1 Oct 2025.

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