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

Riphah International University

Status: Completed

Conditions: Periodontitis; Diabetes Mellitus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06027151

Riphah/IIMC/IRC/22/2070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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380 participants in 4 patient groups

Scaling and root planning

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Drug: 1ml of 1% metronidazole gel

Scaling and root planning plus minocycline gel

Experimental group

Description:

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.

Treatment:

Drug: 1ml of 2% minocycline gel

Scaling and root planning plus combination of metronidazole and minocycline gels

Experimental group

Description:

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.

Treatment:

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