Authors
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Boariu, Marius -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2019
INTERVENTION: All patients were investigated clinically and radiographically at baseline (before therapy). The following clinical parameters were assessed: periodontal pocket depth (PPD), clinical attachment level (CAL), full mouth bleeding score (FMBS), and full‐mouth plaque score (FMPS). The evaluation of the periodontal parameters was recorded in the periodontal chart (http://www.periodontalchart‐online.com/uk/), saved in a .pdf format, printed and attached to each patient’s observation file, at baseline and at the three months reevaluation by measuring the PPD and the CAL at six sites per tooth (mesio‐buccal, buccal, disto‐buccal, disto‐lingual, lingual and mesio‐lingual) at all teeth, excluding third molars, to the nearest millimeter, with a periodontal probe (PCPUNC 15, Hu‐Friedy, Chicago, IL, USA), using the cement–enamel junction (CEJ) as a reference point for the CAL. When CEJ was missing (prosthodontic restoration), measurements was made using as reference point the most apically located margin of the restoration. Tooth mobility was recorded based on the Miller classification (Miller 1985), and the furcation involvement (FI) was classified according to Hamp et al. 1975, using a Nabers probe #2N hdl #7, markings: 3‐6‐9‐12mm, (Hu‐Friedy®, Chicago, IL, USA). After the measurements, all pockets with PPD=4 mm were scaled and root planed under local anesthesia by the same clinician (SB) with Gracey curettes (Hu‐Friedy®, Chicago, IL, USA) and ultrasonic instruments (Piezon®250, Electro Medical Systems SA, Nyon, Switzerland), following the protocol of One‐Stage‐Full‐Mouth‐Disinfection (OSFMD, Quirynen et al. 1995). As home care, patients were advised to rinse twice daily for 2 min. with a 0.2% Chlorhexidine digluconate solution (Dentaton, Ghimas S.p.A., Casalecchio di Reno, Bologna, Italy) for 14 days. At the end of the non‐surgical therapy session, one investigator (the randomizer, SIS) allocated each patient to one of the th CONDITION: Chronic periodontitis ; Oral Health ; Chronic periodontitis PRIMARY OUTCOME: Periodontal pocket depth measured with a periodontal probe (PCPUNC 15, Hu‐Friedy, Chicago, IL, USA) at baseline (initial evaluation) and after three months INCLUSION CRITERIA: 1. Men and women >25 years of age 2. No periodontal therapy or antibiotic intake in the previous 6 months 3. At least 10 natural teeth present in the oral cavity clinically distributed in all four quadrants 4. Bleeding on probing 5. At least 6 teeth with at least one site each with pocket depth (PD) = 5 mm at baseline 6. Clinic and radiographic signs of generalized chronic periodontitis (Armitage 1999) SECONDARY OUTCOME: ; Measured at baseline (initial evaluation) and after three months:; 1. Clinical attachment level measured at six sites per tooth (mesio‐buccal, buccal, disto‐buccal, disto‐lingual, lingual and mesio‐lingual) at all teeth, excluding third molars, to the nearest millimeter with a periodontal probe (PCPUNC 15, Hu‐Friedy, Chicago, IL, USA), using the cement–enamel junction as a reference point for the clinical attachment level.; 2. Plaque assessed with the full‐mouth plaque score (FMPS); 3. Bleeding assessed with the full‐mouth bleeding score (FMBS); 4. Number of sites with PPD =6 mm (considered deep periodontal pockets) measured with a periodontal probe (PCPUNC 15, Hu‐Friedy, Chicago, IL, USA); 5. Microbiological parameters evaluated through polymerase chain reaction (PCR) testing using the commercial micro‐Ident® kit (Hain Lifescience GmbH, Nehren, Germany) and microbial resistance using the Epsilometer technique (E‐test®, AB Biodisk, Solna, Sweden); 6. Biochemical parameters assessed from plasma samples, analyzing the reactive oxygen metabolites and the biological antioxidant potential through photometric methods (Diacron International®, Grosseto, Italy);
Epistemonikos ID: 2f9ce2c0114d1486a2f1633d645f78f778cfdfd5
First added on: Aug 24, 2024