Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes

NCT03374176 | Completed Phase 3 Results DMC

• 1 other identifier: CUT2017002
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Periodontitis is an inflammation of the supporting structures of the teeth, usually caused by specific or groups of microorganisms that results in the progressive destruction of the periodontal ligament and alveolar bone. the objective of periodontitis treatment is to reduce the number of periodontal pathogens. However, there is not an agreement in the use of systemic antibiotics in patients with diabetes. The purpose of the present study was to determine the efficacy of amoxicillin/metronidazole compared to clindamycin during non-surgical treatment of periodontitis in patients with type 2 diabetes mellitus. Patients and methods In this double-blind, randomized clinical trial, a total of 42 patients with chronic periodontitis and type 2 diabetes were included in a 24-months follow-up. Patients were randomly assigned to treatment with either amoxicillin/metronidazole or clindamycin every for 7 days. Clinical determinations (depth of probing, bleeding at the probe and plaque index) were performed to determine the extent and severity of periodontitis before and after the pharmacological treatment. The intra-group differences were calculated with Wilcoxon rank test. The inter-group differences were calculated with Mann-Whitney test. Sex, bacterial plaque, and bleed to the sounding were summarized using proportions and analyzed with the chi-square method. In all analyses, a P-value of \<0.05 (two tailed) was considered statistically significant

Conditions

Periodontitis; Periodontal Pocket; Diabetes Mellitus

Keywords

periodontitis; diabetes mellitus; systemic antimicrobials

Outcome Measures

Primary Outcomes (1)

• Probing Depth

  The size of the periodontal pocket

  7 days

Secondary Outcomes (3)

• Sites With Plaques

  7 days

• Sites With Bleeding on Probing

  7 days

• Total Count of All Teeth Lost Across All Participants

  2 years

Study Arms (2)

AMX-MET

ACTIVE COMPARATOR

AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules. 1 capsule tid during 7 days.

Drug: Amoxicillin 500 mg / Metronidazole 250 mg

Clindamycin

EXPERIMENTAL

Clindamycin Clindamycin 300 mg + placebo. Capsules. 1 capsule tid during 7 days.

Drug: Clindamycin 300 mg

Interventions

Amoxicillin 500 mg / Metronidazole 250 mg DRUG

Subjects were instructed to take a capsule three times a day for 7 days

AMX-MET

Clindamycin 300 mg DRUG

Subjects were instructed to take a capsule three times a day for 7 days

Clindamycin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes
• Age \>18 to 70 years
• Diagnosis of chronic periodontitis according to the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions
• History of type 2 diabetes
• HbA1C \< 8 %
• Fasting plasma glucose (FPG) \< 180 mg/dL.

You may not qualify if:

• Aggressive periodontitis
• Pregnant or lactating females,
• Required antibiotic pre-medication for the performance of periodontal examination and treatment or received antibiotic treatment in the previous 3 months were excluded.
• A history of anti-inflammatory therapy within preceding six months
• Had received a course of periodontal treatment within the last 6 months,
• Allergies to penicillin, metronidazole or clindamycin,
• Not able to provide consent to participate in the study

Sponsors & Collaborators

• Centro Universitario de Tonalá: lead

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket; Diabetes Mellitus

Interventions

Amoxicillin; Metronidazole; Clindamycin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates

Limitations and Caveats

The prin- cipal limitation of the present study was the absence of a group with SRP plus placebo. This study design, using a placebo group, could help us to evaluate the efficacy of clindamycin versus SRP alone.

Results Point of Contact

• Title: Dr. Arieh Roldán Mercado Sesma
• Organization: Centro Universitario de Tonalá, Universidad de Guadalajara

arieh.mercado@academicos.udg.mx

+52 (33) 20 00 23 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research professor associate B

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 15, 2017
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2017
• Last Updated: September 16, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share