Clinical Trial Details
| Trial ID: | L5736 |
| Source ID: | NCT02800252 |
| Associated Drug: | Placebo |
| Title: | Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus|Chronic Periodontitis |
| Interventions: | DRUG: Placebo|DRUG: 3g omega-3 plus 100mg aspirin daily for 60 days|DRUG: omega-3 plus aspirin before periodontal therapy |
| Outcome Measures: | Primary: Periodontal pockets with mean probing depth (PD) ≥5mm, Baseline, 90 days, 180 days | Secondary: Probing depth (mm), Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA), Baseline, 90 days, 180 days|Clinical attachment level (mm), Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA), Baseline, 90 days, 180 days|Gingival recession (mm), Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA), Baseline, 90 days, 180 days|Bleeding on probing (%), Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA), Baseline, 90 days, 180 days|Plaque index (%), Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA), Baseline, 90 days, 180 days | Other: Glycated hemoglobin, Baseline, 180 days |
| Sponsor/Collaborators: | Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho | Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 75 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2016-06 |
| Completion Date: | 2018-12 |
| Results First Posted: | |
| Last Update Posted: | 2016-11-23 |
| Locations: | UNESP, São José dos Campos, SP, 12245-000, Brazil |
| URL: | https://clinicaltrials.gov/show/NCT02800252 |
