Natural Enzyme Mouthwash After Third Molar Surgery

NCT07627945 | Completed DMC

• 1 other identifier: GAL007-0000000619-M206
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Impacted Third Molar; Postoperative Pain; Trismus; Wound Healing

Keywords

impacted mandibular third molar; ORAL7®; Chlorhexidine; wound healing; pain score; mouth opening

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain Score

  Assessment of postoperative pain intensity using the Visual Analogue Scale (VAS) ranging from 0 to 10 following surgical removal of impacted mandibular third molars.

  Daily from Postoperative Day 1 to Postoperative Day 7

• Landry Wound Healing Index Score

  Assessment of postoperative soft tissue healing using the Landry Wound Healing Index following surgical removal of impacted mandibular third molars. Healing will be evaluated based on tissue color, bleeding on palpation, granulation tissue, incision margin condition, and suppuration.

  Postoperative Day 7

• Postoperative Mouth Opening

  Assessment of postoperative mouth opening measured in millimeters between the maxillary and mandibular incisal reference points following surgical removal of impacted mandibular third molars.

  Preoperative baseline and Postoperative Day 7

Secondary Outcomes (1)

• Analgesic Consumption

  Daily from Postoperative Day 1 to Postoperative Day 7

Study Arms (2)

ORAL7® Enzyme-Containing Mouthwash Group

EXPERIMENTAL

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.

Drug: ORAL7® Mouthwash

0.2% Chlorhexidine Gluconate Mouthwash Group

ACTIVE COMPARATOR

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.

Drug: 0.2% Chlorhexidine Gluconate Mouthwash

Interventions

ORAL7® Mouthwash DRUG

Enzyme-containing mouthwash used postoperatively after surgical removal of impacted mandibular third molars. Contains lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase. Used as a 10 mL rinse for 30 seconds, three times daily for 7 days starting from postoperative day 1.

ORAL7® Enzyme-Containing Mouthwash Group

0.2% Chlorhexidine Gluconate Mouthwash DRUG

Standard antiseptic mouth rinse used following oral surgery. Participants rinse with 10 mL for 30 seconds, three times daily for 7 days starting from postoperative day 1.

0.2% Chlorhexidine Gluconate Mouthwash Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• MBD MARKETING SDN. BHD.: lead

Study Sites (1)

Oral and Maxillofacial Surgery Unit, School of Dental Sciences, Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Pain, Postoperative; Trismus

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 4, 2026
• Study Start: October 6, 2025
• Primary Completion: May 20, 2026
• Study Completion: May 20, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)