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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06027151
• Other study ID #: Riphah/IIMC/IRC/22/2070
• Status: Completed
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Periodontitis

Intervention

Drug:
• 1ml of 1% metronidazole gel
1ml of 1% metronidazole gel subgingivally at baseline visit
• 1ml of 2% minocycline gel
1ml of 2% minocycline gel sub gingivally at baseline visit
• 1ml of combination of 1% metronidazole gel and 2% minocycline
1ml of the combination of 1% metronidazole gel and 2% minocycline subgingivally at baseline visit

Locations

Country	Name	City	State
Pakistan	Islamic International Medical Collège, IIMC	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	15 days
Secondary	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.	15 days
Secondary	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.	15 days
Secondary	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	15 days
Secondary	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.	15 days