Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
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2015
INTERVENTION: Periodontitis patients were randomized using a coin toss into 4 months supplementation with omega‐3 or placebo in a parallel double‐blinded design. All patients received non‐surgical periodontal treatment which consisted of oral hygiene instructions and supra‐ and sub‐gingival scaling and root planing (SRP) under local anesthesia. The treatment was performed by an experienced periodontist (GLM) with manual (Gracey and McCall curettes, Hu‐Friedy, Chicago, IL, USA) and ultrasonic (Cavitron select, Dentsply, York, PA, USA) instruments. On average, the treatment required four 50‐min sessions. The intervention group received omega‐3 dietary supplementation (3 capsules of 300 mg omega‐3 (180 mg EPA/120 mg DHA)/day), and the control group received placebo (3 capsules of 450 mg gelatin/day) (Quintaessencia, Rio de Janeiro, Brazil). Patients of both groups received three containers of 30 capsules/month. Compliance was assessed by the return of empty containers, and assessed weekly at visits to the clinic or by telephone calls. The bottles were not decoded until follow‐up evaluations and analyses had been performed to ensure a proper double‐blind study protocol. CONDITION: Periodontal diseases, gingivitis and periodontitis ; Digestive System ; Gingivitis and periodontal diseases PRIMARY OUTCOME: Periodontal examination included bleeding on probing (BOP), O'Leary's plaque index (PI), probing depth (PD), and clinical attachment level (CAL). The PD and CAL were recorded at 6 sites per tooth (mesio‐buccal, mid‐buccal, disto‐buccal, mesio‐lingual, mid‐lingual, and disto‐lingual), excluding the third molars, using a periodontal computerized probe (Florida Probe, Gainesville, FL, USA). The intra‐examiner concordance was 98% within the interval of ± 0.5 mm for PD and CAL. Timepoints: baseline, 4th month and 12th month SECONDARY OUTCOME: Gingival crevicular fluid was collected between 8 h and 12 h as previously described [Figueredo and Gustafsson 1998]. Measurements of a panel of cytokines and chemokines in GCF were performed using a Luminex 200 analyzer (Alameda, CA, USA) with Milliplex kits (Millipore, Billerica, MA, USA) according to the manufacturer’s instructions. Fifty µL of GCF was used to analyze the levels of IL‐1ß, IL‐2, IL‐4, IL‐6, IL‐8, IL‐10, interferon (IFN)‐?, osteocalcin (OC), osteoprotegerin (OPG) and RANK‐L. Timepoints: baseline, 4th month and 12th month INCLUSION CRITERIA: 1. Adults aged over 18 with generalized chronic periodontitis seeking treatment at the dental school of the Rio de Janeiro State University (UERJ), Rio de Janeiro, Brazil between 2010 and 2011. An experienced specialist in periodontology diagnosed patients according to the criteria of the American Academy of Periodontology (AAP). 2. Having moderate‐severe periodontitis (attachment loss = 3 mm and periodontal pocket = 5 mm) in at least 4 interproximal sites from different teeth, and having at least 15 own teeth 3. A group of plaque‐induced gingivitis patients was used as controls: at least 20 own teeth with no interproximal attachment loss and presence of bleeding in = 30% of sites
Epistemonikos ID: 88fa173f81e5ed533fa0c8cd061f1409a4a558d1
First added on: Aug 23, 2024