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Clinical Trial Details

Trial ID: L1977
Source ID: NCT03374176
Associated Drug: Amoxicillin 500 Mg / Metronidazole 250 Mg
Title: Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03374176/results
Conditions: Periodontitis|Periodontal Pocket|Diabetes Mellitus
Interventions: DRUG: Amoxicillin 500 mg / Metronidazole 250 mg|DRUG: Clindamycin 300 mg
Outcome Measures: Primary: Probing Depth, The size of the periodontal pocket, 7 days | Secondary: Sites With Plaques, 0: no plaque 1. separate flecks of plaque at the cervical margin of the tooth 2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth 3. a continuous band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth 4. plaque covering at least one-third but less than two-thirds of the crown of the tooth 5. plaque covering two-thirds or more of the crown of the tooth. A higher scores mean a worse outcome, 7 days|Sites With Bleeding on Probing, Refers to bleeding on probing 0: absence of inflammation 1. mild inflammation; a slight change in color, little change in the texture of any portion of but not the entire marginal or papillary gingival unit 2. mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit 3. moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4; severe inflammation; marked redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration, 7 days|Total Count of All Teeth Lost Across All Participants, The total count of all teeth lost in all participants., 2 years
Sponsor/Collaborators: Sponsor: Centro Universitario de Tonalá
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 42
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-03
Completion Date: 2017-09
Results First Posted: 2020-06-23
Last Update Posted: 2020-09-16
Locations:
URL: https://clinicaltrials.gov/show/NCT03374176