Effect of periodontal therapy with splinting of posterior teeth on masticatory muscles activity and quality of life in stage II, III periodontitis - a prospective randomised control trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- changes in masticatory muscle activity in individuals with Generalised stage II, III Periodontitis after periodontal therapy along with splinting of Premolars & Molars.
研究概览
简要总结
This is a prospective randomized controlled trial with the primary aim to compare the changes in masticatory muscle activity and Quality of life in individuals with Generalised stage II, and III Periodontitis before and after periodontal therapy along with splinting of Premolars and Molars. the hypothesis behind the study there is a difference in masticatory muscle activity in individuals with Generalised stage II, and III Periodontitis after periodontal therapy and splinting of Premolars and Molars. The primary outcome will be the changes in masticatory muscle activity and an improvement in the Quality of an individual’s life with Generalised stage II, and III Periodontitis after periodontal therapy along with splinting of Premolars and Molars. the secondary outcome will be the advantage of splinting of molars and premolars on masticatory muscles activity because of the summation of PDL mechanoreceptors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with Generalised Stage II, III Periodontitis with the following criteria will be selected for the study and control group.
- •i)Age 30 to 60 years.
- •ii)Individuals with more than 20 vital teeth with the presence of upper and lower premolars and first, and second molars.
- •iii)None of the molars & premolars will have a crown, FPD, or endodontic lesion.
- •iv)With probing pocket depth (PPD) > 4mm and Clinical attachment loss (CAL) > 3mm i.e. Stage II, III Periodontitis.
排除标准
- •i)Systemic conditions that affect the periodontium and muscles of mastication.
- •ii)Patients with Temporomandibular joint disorders and Myofunctional Pain Dysfunction Syndrome, Bruxism.
- •iii)Pregnancy and lactation.
- •iv)Central nervous system disorders.
- •v)Individuals with dental implants.
- •v)History of periodontal or orthodontic treatment in the last 6 months.
- •Individuals taking antihistamines, sedatives, Homoeopathic medical medicines, or central nervous system depressants, which may interfere with muscular activity.
结局指标
主要结局
changes in masticatory muscle activity in individuals with Generalised stage II, III Periodontitis after periodontal therapy along with splinting of Premolars & Molars.
时间窗: 3 years
次要结局
- An improvement in Quality of individual’s life with Generalised stage II, III Periodontitis after periodontal therapy along with splinting of Premolars & Molars.(3 years)
研究者
Dr Manish A Ashtankar
VYWS Dental College & Hospital Amravati