The Effects of Natural Enzyme-Containing Mouthwash in Wound Healing After Surgical Removal of Impacted Mandibular Third Molar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
研究概览
简要总结
This clinical study investigates whether a natural enzyme-containing mouthwash (ORAL7®) can improve healing, pain and mouth opening after the surgical removal of impacted lower wisdom teeth (mandibular third molars), compared to a commonly used antiseptic mouthwash (0.2% chlorhexidine gluconate).
Wisdom tooth removal is a routine dental surgery, but it can lead to common postoperative problems such as pain, swelling, difficulty in opening the mouth, and delayed healing of the surgical wound. After surgery, patients are usually advised to use an antiseptic mouthwash to reduce bacteria in the mouth and support healing. Chlorhexidine mouthwash is widely used for this purpose, but it may cause side effects such as tooth staining, taste disturbance, and irritation in some patients.
ORAL7® is a newer type of mouthwash that contains natural enzymes similar to those found in saliva, including lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase. These enzymes help the mouth's natural defense system by reducing harmful bacteria, controlling inflammation, and supporting tissue repair. Because of these properties, ORAL7® may offer a gentler alternative to chlorhexidine while still promoting good healing.
The study will involve patients undergoing surgical removal of impacted lower wisdom teeth. After surgery, participants will be randomly assigned to use either ORAL7® mouthwash or 0.2% chlorhexidine mouthwash for one week. Neither group will know which mouthwash they are using in order to reduce bias. The researchers will then monitor healing by measuring wound recovery, pain levels, and how easily patients can open their mouths during the first week after surgery.
The main outcome being studied is how well the surgical wound heals after one week. Additional outcomes include the level of pain experienced each day and the degree of mouth opening after surgery.
Study Hypothesis
The study hypothesis is that patients using ORAL7® mouthwash will have similar or better wound healing, less postoperative pain, and improved mouth opening compared to patients using 0.2% chlorhexidine mouthwash after wisdom tooth surgery.
详细描述
This study is a single-blinded, randomized controlled clinical trial designed to evaluate the effects of a natural enzyme-containing mouthwash (ORAL7®) on postoperative outcomes following the surgical removal of impacted mandibular third molars, in comparison with 0.2% chlorhexidine gluconate (CHX) mouthwash.
Postoperative management following third molar surgery typically includes antiseptic mouth rinses to reduce microbial load and support soft tissue healing. While chlorhexidine remains the standard adjunctive mouthwash due to its broad-spectrum antimicrobial activity, its use is associated with well-documented adverse effects, including tooth staining, taste alteration, and potential cytotoxic effects on oral tissues. These limitations have prompted increasing interest in alternative agents that can support oral wound healing while maintaining antimicrobial efficacy.
ORAL7® is an enzyme-based oral rinse formulated to mimic components of the innate salivary defense system. It contains lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase, which collectively contribute to antimicrobial activity through enhancement of the lactoperoxidase-thiocyanate-hydrogen peroxide system. This enzymatic system supports microbial homeostasis, limits pathogenic bacterial growth, and may contribute to a more favorable environment for tissue repair without disrupting normal oral microflora to the same extent as conventional antiseptics.
The biological rationale for this intervention is based on the role of salivary enzymes in regulating inflammation, microbial colonization, and tissue regeneration. Lactoperoxidase generates antimicrobial hypothiocyanite ions, lysozyme disrupts bacterial cell walls and modulates inflammatory activity, lactoferrin regulates iron availability while supporting immune modulation and tissue repair, and glucose oxidase contributes to controlled hydrogen peroxide production that sustains enzymatic antimicrobial activity. Collectively, these mechanisms may influence early wound healing dynamics, postoperative discomfort, and functional recovery.
Eligible participants undergoing surgical extraction of impacted mandibular third molars under local anesthesia will be allocated into either the ORAL7® group or the CHX group using a randomized allocation method with allocation concealment. Postoperative care will be standardized across both groups except for the assigned mouthwash regimen.
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
- Triple (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
- 是
入选标准
- •18 years old and older until required number of samples has been obtained
- •Impacted mandibular third molar required bone removal
- •Absence of acute infection in impacted mandibular third molar
- •Absence of deep caries in the adjacent tooth
- •No known medical illness
- •No known drug allergy
- •Not on medication (prescribed or over the counter)
排除标准
- •1 Mandibular third molar with soft tissue impaction only
- •Distoangulated tooth with deep impaction.
- •Active smoker
- •Pregnant women
- •Patients undergoing removal of impacted mandibular third molar due to trauma justification, such as the impacted tooth is at the fractured site.
- •Mentally challenged patient
研究组 & 干预措施
ORAL7® Enzyme-Containing Mouthwash Group
ORAL7® Enzyme-Containing Mouthwash Group
Participants in this arm will receive ORAL7® mouthwash as the postoperative rinse following surgical removal of impacted mandibular third molars. ORAL7® is an enzyme-based oral rinse containing lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase, which support the natural salivary antimicrobial system. Participants will be instructed to rinse with approximately 10 mL of the mouthwash for 30 seconds, three times daily for 7 days starting on the first postoperative day.
干预措施: ORAL7® Mouthwash (Drug)
0.2% Chlorhexidine Gluconate Mouthwash Group
0.2% Chlorhexidine Gluconate Mouthwash Group
Participants in this arm will receive 0.2% chlorhexidine gluconate mouthwash as the postoperative rinse following surgical removal of impacted mandibular third molars. Chlorhexidine is a broad-spectrum antiseptic commonly used in oral surgery to reduce microbial load and support wound healing. Participants will be instructed to rinse with approximately 10 mL of the solution for 30 seconds, three times daily for 7 days starting on the first postoperative day.
干预措施: 0.2% Chlorhexidine Gluconate Mouthwash (Drug)
研究者
Dr. Nabeel Reza
Principle Investigator
MBD MARKETING SDN. BHD.