A Randomized Controlled Trial on the Effect of Different Types of Mouthwash on the Healing of Extraction Sockets
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Extraction socket soft tissue healing
研究概览
简要总结
The goal of this clinical trial is to assess the effect of four different types of mouthwash on socket healing after surgical extractions in male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar indicated for extraction. The main questions it aims to answer are:
The effect of Bone Bioactive Liquid (BBL) mouthwash, Hyaluronic Acid (HA) mouthwash, the Chlorhexidine digluconate (CHX) mouthwash and Warm Saline Mouth Rinse (WSMR) on socket healing after surgical extractions.
The effect of BBL mouthwash, HA mouthwash, the CHX mouthwash and WSMR on patient related factors and their quality of life.
Recruited Participants will be randomized into four intervention groups:
- First group will receive BBL mouthwash.
- The second group will receive CHX mouthwash.
- The third group will be prescribed HA mouthwash.
- The fourth group will receive Warm Saline Mouth Rinse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar that is indicated for extraction with bone removal and the presence of an adjacent second molar.
排除标准
- •Soft tissue impaction that will not need any bone removal.
- •Presence of any acute oral infection including active Pericoronitis.
- •Patients who have undergone radiotherapy in the head and neck region, chemotherapy or systemic long-term corticosteroid treatment.
- •Patients receiving medications known to induce gingival hyperplasia; anticonvulsant (phenytoin), immunosuppressant (cyclosporine A), and various calcium channel blockers (nifedipine, verapamil, diltiazem).
- •Patients who have taken systemic antibiotics less than 3 months prior to baseline.
- •Presence of uncontrolled diabetes, severe nutritional deficiencies and endocrine disturbances.
- •Presence of immune deficiency or any immune disease.
- •Intravenous bisphosphonates or Oral bisphosphonate intake for more than 3 years.
- •Smokers and alcoholics.
- •Pregnant or lactating females.
- •Hypersensitivity to one of the ingredients listed in any of the mouthwashes, especially chlorhexidine as reactions to this has been reported in the literature.
研究组 & 干预措施
Bone Bioactive Liquid
Bone bioactive liquid (BBL) is a saline solution used as a mouthwash that contains calcium chloride (CaCl2) and magnesium dichloride hexahydrate (MgCl2-6H2O) with a net negative charge.
干预措施: Bone Bioactive Liquid (Drug)
Warm Saline Mouth Rinse
Prescribing WSMR as a prophylactic postoperatively is due to the fact that the heat of the solution results in a therapeutic increase in blood flow to the extraction socket.
干预措施: Warm Saline Mouth Rinse (Drug)
Chlorhexidine Gluconate
It is a strong bisbiguanide base, with cationic structure at physiological pH (positively charged), and has a broad-spectrum antibacterial activity that works against Gram-positive and Gram- negative bacteria and certain mycetes.
干预措施: Chlorhexidine Gluconate (Drug)
Hyaluronic Acid mouthwash
It is a high molecular weight non-sulphated polysaccharide. It is biocompatible, non-immunogenic, biodegradable, viscoelastic that make it a preferable biomaterial for medical and pharmaceutical applications without adverse events.
干预措施: Hyaluronic Acid mouthwash (Drug)
结局指标
主要结局
Extraction socket soft tissue healing
时间窗: Measured at 3, 7, 14 days, 3 and 6 months postoperatively.
Using a new socket wound healing scale that is a combination of the gingival healing index of Landry et al. and the wound healing scale used by Cervelli et al. to assess the post-extraction wounds in terms of wound dehiscence, epithelialization, quality of granulation tissue filling the post-extraction socket, and depth between early granulation tissue and wound margin. A blunt periodontal probe with millimetric markers will be used for this assessment to score a number between 0 (best) and 4 (worst) for the healing socket.
次要结局
- Extraction socket Bone healing(Radiographs will be taken at baseline and at 6 months after extraction.)
- Quality of life of the patients (QOL) after extraction(At 3, 7, 14 days, 3 and 6 months postoperatively.)
- Pain at the extraction side(At 3, 7, 14 days, 3 and 6 months postoperatively.)
- Trismus(Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.)
- Facial swelling at the extraction side(Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.)
- Socio-demographic factors and medical history(Once preoperatively.)
- Pre-operative factors(Once preoperatively.)
- The resulting periodontal defect of the adjacent second molar(Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months)
- Peri-operative factors(During the surgical procedure.)
研究者
Ahmad Abdel-Salam Hamdan
Associate Professor, Periodontology
University of Jordan