Clinical trial NCT06027151: Comparing the Efficacy of Metronidazole and Minocycline Gels for the Treatment of Diabetic Periodontitis Patients
Official title: Comparing the Efficacy of Metronidazole and Minocycline Gels for the Treatment of Diabetic Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Diabetes Mellitus
Keywords: Chronic periodontitis
Minocycline gel
Scaling and root planning
Metronidazole gel
Efficacy of local administration
Diabetes mellitus
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 380
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PERIODONTAL POCKET DEPTH (PPD)
timeFrame: 15 days
Secondary outcomes:
measure: COLOR OF GINGIVA
timeFrame: 15 days
measure: TEXTURE OF GINGIVA
timeFrame: 15 days
measure: BLEEDING ON PROBING (BOP)
timeFrame: 15 days
measure: CLINICAL ATTACHMENT Level
timeFrame: 15 days
measure: RECESIION OF GINGIVAL MARGIN:
timeFrame: 15 days
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Islamic International Medical Collège, IIMC
state: Punjab
Study officials:
affiliation: Riphah International University, Rawalpindi
name: Aeman Choudhary, BDS
role: PRINCIPAL_INVESTIGATOR
References: