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

NCT06027151 | Completed

• 1 other identifier: Riphah/IIMC/IRC/22/2070
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Periodontitis; Diabetes Mellitus

Keywords

Chronic periodontitis; Minocycline gel; Scaling and root planning; Metronidazole gel; Efficacy of local administration; Diabetes mellitus

Outcome Measures

Primary Outcomes (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.

  15 days

Secondary Outcomes (5)

• COLOR OF GINGIVA

  15 days

• TEXTURE OF GINGIVA

  15 days

• BLEEDING ON PROBING (BOP)

  15 days

• CLINICAL ATTACHMENT Level

  15 days

• RECESIION OF GINGIVAL MARGIN:

  15 days

Study Arms (4)

Scaling and root planning

NO INTERVENTION

Once 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 gel

EXPERIMENTAL

After 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.

Drug: 1ml of 1% metronidazole gel

Scaling and root planning plus minocycline gel

EXPERIMENTAL

After 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.

Drug: 1ml of 2% minocycline gel

Scaling and root planning plus combination of metronidazole and minocycline gels

EXPERIMENTAL

After 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.

Drug: 1ml of combination of 1% metronidazole gel and 2% minocycline

Interventions

1ml of 1% metronidazole gel DRUG

Subgingivally at baseline visit

Also known as: metronidazole

Scaling and root planning plus metronidazole gel

1ml of 2% minocycline gel DRUG

sub gingivally at baseline visit

Also known as: minocycline

Scaling and root planning plus minocycline gel

1ml of combination of 1% metronidazole gel and 2% minocycline DRUG

subgingivally at baseline visit

Also known as: metronidazole/minocycline

Scaling and root planning plus combination of metronidazole and minocycline gels

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Islamic International Medical Collège, IIMC

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus; Chronic Periodontitis

Interventions

Metronidazole; Minocycline

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Aeman Choudhary, BDS

  Riphah International University, Rawalpindi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind, patient was unaware of which drug they were administered. It was done by covering the syringes with colored tapes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: October 6, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)