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

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT06027151

Collaborator

(none)

380

Enrollment

Location

Arms

9.8

Actual Duration (Months)

38.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Diabetes Mellitus	Drug: 1ml of 1% metronidazole gel Drug: 1ml of 2% minocycline gel Drug: 1ml of combination of 1% metronidazole gel and 2% minocycline	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

single blind, patient was unaware of which drug they were administered. It was done by covering the syringes with colored tapes

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 6, 2022

Actual Primary Completion Date :

Jul 31, 2023

Actual Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Scaling and root planning 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.
Experimental: Scaling and root planning plus metronidazole gel 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 1ml of 1% metronidazole gel subgingivally at baseline visit
Experimental: Scaling and root planning plus minocycline gel 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 1ml of 2% minocycline gel sub gingivally at baseline visit
Experimental: Scaling and root planning plus combination of metronidazole and minocycline gels 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 1ml of the combination of 1% metronidazole gel and 2% minocycline subgingivally at baseline visit

Outcome Measures

Primary Outcome Measures

PERIODONTAL POCKET DEPTH (PPD) [15 days]
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.

Secondary Outcome Measures

COLOR OF GINGIVA [15 days]
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.
TEXTURE OF GINGIVA [15 days]
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.
BLEEDING ON PROBING (BOP) [15 days]
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.
CLINICAL ATTACHMENT Level [15 days]
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
RECESIION OF GINGIVAL MARGIN: [15 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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