Natural Enzyme Mouthwash After Third Molar Surgery

The Effects of Natural Enzyme-Containing Mouthwash in Wound Healing After Surgical Removal of Impacted Mandibular Third Molar

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Trismus; Wound Healing; Impacted Third Molar
• Intervention / Treatment: Drug: ORAL7® Mouthwash; Drug: 0.2% Chlorhexidine Gluconate Mouthwash

Detailed Description

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.

Participants will be instructed to use the allocated mouthwash for a fixed period following surgery, and postoperative recovery will be monitored over the first week. Clinical assessments will focus on soft tissue healing status at the surgical site, patient-reported pain intensity, and functional limitation related to mouth opening. These outcomes reflect key domains of postoperative recovery in oral surgery, including tissue repair, inflammation-related discomfort, and functional impairment.

The study is designed to generate comparative clinical evidence regarding whether an enzyme-based oral rinse can provide equivalent or improved postoperative outcomes compared to chlorhexidine, particularly in terms of wound healing quality, pain reduction, and recovery of mandibular function. Findings may contribute to optimizing postoperative oral care protocols and reducing reliance on antiseptic agents with known side-effect profiles.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Oral and Maxillofacial Surgery Unit, School of Dental Sciences, Universiti Sains Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: ORAL7® Mouthwash; 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.
Active Comparator: 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.	Drug: 0.2% Chlorhexidine Gluconate Mouthwash; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic Consumption	Assessment of the total number of analgesic medications consumed following surgical removal of impacted mandibular third molars. Analgesic use will include prescribed celecoxib and rescue paracetamol intake recorded daily by participants.	Daily from Postoperative Day 1 to Postoperative Day 7

Collaborators and Investigators

• Sponsor: MBD MARKETING SDN. BHD.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2025
• Primary Completion (Actual): May 20, 2026
• Study Completion (Actual): May 20, 2026

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: wound healing; Chlorhexidine; pain score; mouth opening; impacted mandibular third molar; ORAL7®
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Postoperative Complications; Pathologic Processes; Spasm; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Trismus
• Other Study ID Numbers: GAL007-0000000619-M206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No