Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 231 for:    clindamycin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03374176
Recruitment Status : Completed
First Posted : December 15, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Arieh Roldán Mercado Sesma, Centro Universitario de Tonalá

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


Condition or disease Intervention/treatment Phase
Periodontitis Periodontal Pocket Diabetes Mellitus Drug: Amoxicillin 500 mg / Metronidazole 250 mg Drug: Clindamycin 300 mg Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in the Treatment of Periodontitis in Patients With Diabetes
Actual Study Start Date : March 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2017


Arm Intervention/treatment
Active Comparator: AMX-MET

AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules.

1 capsule tid during 7 days.

Drug: Amoxicillin 500 mg / Metronidazole 250 mg
Subjects were instructed to take a capsule three times a day for 7 days

Experimental: Clindamycin

Clindamycin Clindamycin 300 mg + placebo. Capsules.

1 capsule tid during 7 days.

Drug: Clindamycin 300 mg
Subjects were instructed to take a capsule three times a day for 7 days




Primary Outcome Measures :
  1. Probing depth [ Time Frame: 7 days ]
    The size of the periodontal pocket


Secondary Outcome Measures :
  1. Bacterial plaque [ Time Frame: 7 days ]
    Percentage of total tooth surfaces that revealed the presence of plaque detected

  2. Bleeding in probing [ Time Frame: 7 days ]
    Presence of bleeding on probing from the bottom of the pocket when probing with a manual probe with a force of 0.3n

  3. Loss of teeth [ Time Frame: 2 years ]
    The count of loss of teeth



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Layout table for additonal information
Responsible Party: Arieh Roldán Mercado Sesma, Research professor associate B, Centro Universitario de Tonalá
ClinicalTrials.gov Identifier: NCT03374176     History of Changes
Other Study ID Numbers: CUT2017002
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arieh Roldán Mercado Sesma, Centro Universitario de Tonalá:
periodontitis
diabetes mellitus
systemic antimicrobials
Additional relevant MeSH terms:
Layout table for MeSH terms
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Periodontitis
Periodontal Pocket
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action