Clinical Efficacy of Three Different Full Mouth Disinfection Protocols for the treatment of Halitosis and Periodontitis- A Comparative Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Periodontal parameters like Gingival index (GI), Plaque Index (PI), Pocket probing depth (PPD), clinical attachment level (CAL) and severity of halitosis using Organoleptic Scoring, Tongue Coating index (TCI) will also be assessed pre and postoperatively at 45 days and 90 days respectively.
研究概览
简要总结
Background: Halitosis (bad breath) and Periodontitis are prevalent oral health conditions with multifactorial causes, significantly impacting individuals’ quality of life and oral health. Traditional treatment methods involve quadrant wise scaling and root planning, conventional full mouth disinfection protocol, but advancements in dental research explore alternative protocols like Herbal Full Mouth Disinfection and Photodynamic Full Mouth Disinfection to enhance outcomes and minimize side effects.
Primary Purpose:
The primary purpose of this study is to evaluate and compare the effectiveness of three full mouth disinfection protocols—Conventional, Herbal, and Photodynamic—in treating Halitosis and Periodontitis. By investigating these approaches, the study aims to identify potentially more effective treatment options that could enhance patient outcomes and minimize side effects associated with traditional methods.
Study Hypothesis:
The hypothesis posits that the Herbal and Photodynamic Full Mouth Disinfection protocols will demonstrate superior efficacy in reducing periodontal pocket depth, improving gingival health, and sustaining malodor reduction compared to the Conventional method, thereby offering more effective alternatives for managing Halitosis and Periodontitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged between 18-65 years and diagnosed with Halitosis and Stage II/III/IV of periodontitis.
- •Halitosis will be confirmed by organoleptic scoring method and by using portable volatile sulfur compound monitor Tanita HC-312F Fitscan Portable Breath Checker.
- •The red code indicates high levels of VSCs suggesting malodor or bad breath.
- •Periodontitis will be classified using AAP 2017 Classification of Periodontal & Peri-implant diseases.
- •Subjects with willingness to participate and provide informed consent.
排除标准
- •Patients with systemic conditions, medications affecting periodontal health and production of volatile sulfur compounds.
- •Subjects with ENT infections, upper and lower respiratory tract infections, GERD, renal diseases, liver disorders
- •Subjects with adverse oral habits like smoking, tobacco or gutkha chewing
- •Individuals with contraindications to specific protocols (e.g., allergies to chemical antiseptics, photosensitizers, herbal components).
- •Pregnant or lactating women.
结局指标
主要结局
Periodontal parameters like Gingival index (GI), Plaque Index (PI), Pocket probing depth (PPD), clinical attachment level (CAL) and severity of halitosis using Organoleptic Scoring, Tongue Coating index (TCI) will also be assessed pre and postoperatively at 45 days and 90 days respectively.
时间窗: Improvements in periodontal health and reduction in halitosis following treatment offered in three treatment groups as evidenced by improvements in outcome variables assessed pre and post operatively (at Baseline, 45 days and 90 days post treatment respectively).
次要结局
- Economic Outcomes: Cost-effectiveness of the treatment, including direct & indirect costs.
研究者
Sameer Anil Zope
School of Dental Sciences, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad