The Clinical Effects of Minimally Invasive NonSurgical Therapy (MINST) as an Alternative of Conventional NonSurgical Periodontal Therapy for Stage III Grade C Periodontitis in Molar Teeth- A 6-month Pilot Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Probing Pocket Depth (PPD)
研究概览
简要总结
This single-center, split-mouth, randomized controlled clinical trial aims to evaluate the clinical effectiveness of Minimally Invasive Non-Surgical Therapy (MINST) as an adjunct to conventional non-surgical periodontal therapy in patients with Stage III/IV periodontitis. Twenty-three systemically healthy adults presenting with bilateral molar teeth exhibiting periodontal pockets ≥5 mm with bleeding on probing will be enrolled. In each participant, molar teeth will be randomly allocated to receive either conventional subgingival scaling and root planing (SRP) using ultrasonic instruments alone (control) or conventional SRP followed by MINST using Mini-Five Gracey curettes under magnification loupes (test). Clinical periodontal parameters, including Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL), will be evaluated at baseline, 3 months, and 6 months after treatment. The study will investigate whether MINST provides superior clinical outcomes compared with conventional non-surgical periodontal therapy.
详细描述
Periodontitis is a chronic inflammatory disease characterized by the destruction of the tooth-supporting tissues. Conventional non-surgical periodontal therapy based on scaling and root planing (SRP) is considered the first-line treatment for periodontal pockets. However, complete removal of subgingival biofilm and calculus may be difficult in deep pockets, furcation areas, and root concavities because of limited access.
Minimally Invasive Non-Surgical Therapy (MINST) has been introduced to improve access to deep periodontal defects while minimizing soft tissue trauma. The technique combines magnification loupes with Mini-Five Gracey curettes to allow more precise instrumentation and preservation of soft tissues during periodontal debridement.
This prospective, single-center, split-mouth randomized controlled clinical trial will include 23 patients diagnosed with Stage III/IV periodontitis. Bilateral molar teeth with probing pocket depth ≥5 mm and bleeding on probing will be randomly assigned to either the test or control intervention within each participant.
The control sites will receive conventional subgingival scaling and root planing using ultrasonic instruments. The test sites will receive conventional ultrasonic instrumentation followed by MINST performed with Mini-Five Gracey curettes under magnification loupes.
All participants will receive oral hygiene instructions and full-mouth supragingival periodontal therapy before subgingival treatment. Scaling and root planing will be completed over two treatment sessions separated by one week. Professional supportive periodontal therapy will be provided during follow-up according to the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 35 years.
- •Diagnosed with Stage III or Stage IV periodontitis.
- •Systemically healthy.
- •Presence of at least two bilateral molar teeth with probing pocket depth (PPD) ≥5 mm and bleeding on probing (BOP).
- •At least 20 remaining teeth.
- •Radiographic evidence of periodontal bone loss.
- •Non-smokers and non-users of tobacco or alcohol.
- •Not pregnant or breastfeeding.
- •Not receiving medications known to affect periodontal healing.
- •Willing and able to provide written informed consent and comply with study procedures.
排除标准
- •Individuals who do not meet the inclusion criteria.
- •Pregnancy or breastfeeding.
- •Presence of systemic diseases or medical conditions affecting periodontal status or healing.
- •Current use of medications that may influence periodontal healing.
- •Current smokers or users of tobacco or alcohol.
- •Individuals unwilling or unable to provide informed consent.
研究组 & 干预措施
MINST Group
Participants assigned to the experimental arm will receive conventional non-surgical periodontal therapy with ultrasonic scaling and root planing followed by Minimally Invasive Non-Surgical Therapy (MINST) using Mini-Five Gracey curettes under magnification loupes. Treatment will be performed over two sessions separated by one week.
干预措施: Minimally Invasive Non-Surgical Therapy (MINST) (Procedure)
Conventional SRP Group
Participants assigned to the control arm will receive conventional non-surgical periodontal therapy consisting of subgingival scaling and root planing using ultrasonic instruments. Treatment will be performed over two sessions separated by one week.
干预措施: Conventional Scaling and Root Planing (Procedure)
结局指标
主要结局
Probing Pocket Depth (PPD)
时间窗: Baseline, 3 months, and 6 months
Change in probing pocket depth (PPD) measured in millimeters using a UNC-15 periodontal probe.
次要结局
- Clinical Attachment Level (CAL)(Baseline, 3 months, and 6 months)
- Bleeding on Probing (BOP)(Baseline, 3 months, and 6 months)
- Plaque Index (PI)(Baseline, 3 months, and 6 months)
- BANA Test(Baseline, 3 months, and 6 months)
研究者
Alparslan Dilsiz
Professor of Periodontology
Ataturk University