Mechanical-chemical Gingival Therapy in Diabetics and/or Obese
关键词
抽象
日期
| 最后验证: | 03/31/2014 |
| 首次提交: | 04/08/2014 |
| 提交的预估入学人数: | 04/22/2014 |
| 首次发布: | 04/24/2014 |
| 上次提交的更新: | 04/22/2014 |
| 最近更新发布: | 04/24/2014 |
| 实际学习开始日期: | 05/31/2012 |
| 预计主要完成日期: | 05/31/2013 |
| 预计完成日期: | 08/31/2013 |
状况或疾病
干预/治疗
Other: Ultrason Essential oils rinse
Other: Ultrason Placebo rinse
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Ultrason Essential oils rinse Ultrasonic debridement followed by twice daily home use of an essential-oils mouth rinse (20mL, 30 seconds for each rinse) for 3 months | Other: Ultrason Essential oils rinse Test treatment strategy combined mechanical and chemical procedures. Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing. Toothbrush, dental floss and fluoride dentifrice were monthly provided. Within the same visit participants performed at the study center the first supervised rinse. Other rinses were performed at home unsupervised. A diary card was used to register times of rinsing. Participants rinsed twice a day a commercially available non-prescription essential-oils solution (20mL, 30 seconds for each rinse) for 3 months. This solution is composed of eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%, zinc chloride and sodium fluoride 0.0221%. |
| Placebo Comparator: Ultrason Placebo rinse Ultrasonic debridement followed by twice daily home use of a placebo rinse (20mL, 30 seconds for each rinse) for 3 months | Other: Ultrason Placebo rinse Comparative treatment strategy combined mechanical and chemical procedures. Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing. Toothbrush, dental floss and fluoride dentifrice were monthly provided. Within the same visit participants performed at the study center the first supervised rinse. Other rinses were performed at home unsupervised. A diary card was used to register times of rinsing. Participants rinsed twice a day a placebo solution (20mL, 30 seconds for each rinse) for 3 months. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - plaque-related gingivitis (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of more than 30%) - periodontally healthy group (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of less than 30%) - at least 20 natural teeth - diabetes group: controlled type II diabetes (with a blood glycated hemoglobin level between 6.5 and 7%) that was diagnosed at least 3 years but no more than 5 years prior to the study - normal salivary flow - obesity group: obesity level I - body mass index: 30 to 34.99 kg/m2 or obesity level II - body mass index: 35 to 39.99 kg/m2 - normal weight group: body mass index: 20 to 24.99 kg/m2; Exclusion Criteria: - gingival overgrowth - orthodontic devices - extended prosthetic fixed devices - removable partial dentures or overhanging restorations - systemic diseases or other conditions that could influence the periodontal status (other than diabetes within the diabetic group) - overweight - BMI 25 to 29.99 kg/m2 and obesity level III or morbid obesity - ≥ 40 kg/m2 (obesity group) - alcohol abuse - pregnancy or breast-feeding - history of sensitivity or suspected allergies following the use of oral hygiene products - the need for antibiotic prophylaxis; antibiotics and/or anti-inflammatory drug use in the six months prior to the beginning of the study - regular use of chemotherapeutic antiplaque/antigingivitis products - periodontal treatment performed within six months prior to study initiation - unwillingness to return for follow-up |
结果
主要结果指标
1. plaque and gingival indices [3 months]
