Natural Enzyme Mouthwash After Third Molar Surgery

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.

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