Impact of MINST With and Without Splinting on Clinical Periodontal Parameters and OHRQoL in Periodontitis Patients With Mobile Anterior Teeth: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Changes in Clinical Attachment Level (CAL)
研究概览
简要总结
The goal of this clinical trial is to evaluate impact of Minimally Invasive Non-Surgical Therapy (MINST) with and without splinting on clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) in periodontitis patients with mobile anterior teeth. The main questions it aims to answer are:
- Does splinting provide additional benefit to MINST alone for improving the clinical periodontal parameters ?
- Does splinting provide additional benefit to MINST alone for improving OHRQoL ?
详细描述
The increased mobility of a periodontally affected tooth can be caused by a shift of centre of rotation of the tooth apically due to clinical attachment loss (CAL) and alveolar bone loss (ABL) and/or due to secondary occlusal trauma.
Tooth splinting continues to be a topic of controversy. It remains one of the most poorly understood and controversial areas of dental therapy.
Minimally invasive non-surgical periodontal therapy (MINST) has been introduced for minimizing tissue trauma and enhancing clinical outcomes by the adjunctive use of magnification devices .
This study aims to compare clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) following Minimally Invasive Non-Surgical Therapy (MINST), both with and without splinting, in patients with Stage III and Stage IV periodontitis who have mobile anterior teeth.
Patients will be screened and enrolled based on specific eligibility criteria. Baseline measurements of outcome parameters will be taken, followed by supragingival scaling, and patients will be recalled after one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria at the patient level: systemically healthy patient with presence of stage III or IV periodontitis, age ≥ 18 years.
- •Tooth-related inclusion criteria: presence of at least one anterior tooth with mobility in combination with a clinical attachment loss (CAL) ≥ 5 mm and a relative alveolar bone loss (ABL) of ≥ 50% at the affected tooth.
- •Dentition with at least 3 antagonistic contact zones opposing posterior teeth, that is Eichner Class A1, A2, A3, B1
排除标准
- •Patients with anterior cross bite
- •Bruxism or signs of parafunction
- •Implant in Anterior teeth
- •Any active periodontal therapy in last 1 year
- •Mobility of teeth due to acute trauma
- •Pulpal or periapical pathology in anterior teeth
- •Patient requiring any emergency dental procedure
- •Patient on antibiotic therapy in last 1 month
- •If patient want to undergo surgical treatment for management of periodontitis.
研究组 & 干预措施
MINST with Splinting
Minimally Invasive Non-Surgical Therapy will be done along with splinting of mobile anterior teeth
干预措施: Splinting (Procedure)
MINST without Splinting
Minimally Invasive Non-Surgical Therapy will be done without splinting of mobile anterior teeth
干预措施: MINST alone (Procedure)
结局指标
主要结局
Changes in Clinical Attachment Level (CAL)
时间窗: 12 - 14 months
Clinical attachment level is the distance between the cemento-enamel junction and the base of pocket.
Changes in Oral Health Related Quality of Life (OHRQoL)
时间窗: 12 - 14 months
OHRQoL will be measured using a validated version of Oral Health Index Profile (OHIP)
次要结局
未报告次要终点