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Completed
NCT07627945
Natural Enzyme Mouthwash After Third Molar Surgery
Conditions: Impacted Third Molar, Postoperative Pain, Trismus, Wound Healing
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 58
Sponsor: MBD MARKETING SDN. BHD.
Location: Oral and Maxillofacial Surgery Unit, School of Dental Sciences, Universiti Sains Malaysia Kota Bharu Kelantan
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07627945). StuddyBuddy aggregates publicly available trial information.