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

• ClinicalTrials.gov Identifier: NCT06027151
• Recruitment Status: Completed
• First Posted: September 7, 2023
• Last Update Posted: September 7, 2023
• Sponsor: Riphah International University
• Information provided by (Responsible Party): Riphah International University

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	Not Applicable

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 (Clinical Trial)
• 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: October 6, 2022
• Actual Primary Completion Date: July 31, 2023
• Actual Study Completion Date: July 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 :

1. PERIODONTAL POCKET DEPTH (PPD) [ Time Frame: 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 :

1. COLOR OF GINGIVA [ Time Frame: 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.
2. TEXTURE OF GINGIVA [ Time Frame: 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.
3. BLEEDING ON PROBING (BOP) [ Time Frame: 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.
4. CLINICAL ATTACHMENT Level [ Time Frame: 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

5. RECESIION OF GINGIVAL MARGIN: [ Time Frame: 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

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Pakistan

Islamic International Medical Collège, IIMC

Rawalpindi, Punjab, Pakistan, 44000

Sponsors and Collaborators

Riphah International University

Investigators

• Principal Investigator: Aeman Choudhary, BDS; Riphah International University, Rawalpindi

More Information

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT06027151
• Other Study ID Numbers: Riphah/IIMC/IRC/22/2070
• First Posted: September 7, 2023
• Last Update Posted: September 7, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Riphah International University:

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

Additional relevant MeSH terms:

Periodontitis; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Metronidazole; Minocycline; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents