The Effect of Topical Application of Hyaluronic Acid and Melatonin Mixture Following Surgical Extraction of Impacted Mandibular Third Molars .

NCT07735806 | Active Not Recruiting

• 1 other identifier: KFSIRB200-170
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to evaluate the clinical and radiographical effects of the application of a mixture of hyaluronic acid and melatonin after surgical extraction of impacted mandibular third molars. Participants are randomly allocated to receive either gel foam loaded with a topical mixture of hyaluronic acid and melatonin ( intervention group ) or gel foam alone ( control group ) following surgical extraction. Clinical outcomes, including postoperative pain, facial swelling, and maximum mouth opening, are assessed on postoperative days 1, 3, and 7. Radiographic bone healing is evaluated using cone-beam computed tomography (CBCT), with a baseline scan obtained within one week after surgery and a follow-up scan performed 6 months postoperatively to assess changes in bone density. The clinical and radiographic outcomes of both groups are compared to determine whether the combined treatment improves postoperative healing following surgical extraction of impacted mandibular third molars

Conditions

Impacted Mandibular Third Molar

Keywords

Impacted mandibular third molar; Third molar extraction; Hyaluronic acid; Melatonin; Bone healing; Bone density; CBCT; Postoperative pain; Facial swelling; Maximum mouth opening

Outcome Measures

Primary Outcomes (1)

• Alveolar bone density changes after surgical extraction of impacted mandibular third molars .

  Assessment of bone density within the extraction socket using cone beam computed tomography ( CBCT) . Bone density values expressed as Hounsfield units (HU) are measured at baseline and at 6 months postoperatively .

  Baseline ( within 1 week after surgery ) and 6 months after surgery .

Secondary Outcomes (3)

• Postoperative pain intensity assessed by Visual Analog Scale (VAS).

  Postoperative days 1 , 3 , and 7

• Maximum Mouth Opening ( MMO) after surgery

  Preoperative baseline and postoperative days 1,3, and 7

• Postoperative facial swelling

  Preoperative baseline and postoperative days 1,3, and 7

Study Arms (2)

Hyaluronic Acid + Melatonin Group ( Experimental )

EXPERIMENTAL

Participants receive a mixture of hyaluronic acid and melatonin into the extraction socket following surgical extraction of impacted mandibular third molars using gel foam as a carrier .

Drug: Hyaluronic acid and Melatonin mixture

Gel foam control group ( control )

ACTIVE COMPARATOR

Participants receive gel foam only applied into the extraction socket following surgical extraction of impacted mandibular third molars .

Other: Gel foam

Interventions

Hyaluronic acid and Melatonin mixture DRUG

A topical mixture of 0.2 % hyaluronic acid gel combined with 3 mg melatonin is applied into the extraction socket following surgical extraction of impacted mandibular third molars using a gel foam carrier .

Hyaluronic Acid + Melatonin Group ( Experimental )

Gel foam OTHER

Gel foam is applied alone into the extraction socket following surgical extraction of mandibular third molars .

Gel foam control group ( control )

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-35 years.
• patients requiring surgical extraction of impacted mandibular third molars classified as Pell and Gregory class II, position B, irrespectiver of the impaction type.
• Patients with normal moueh opening at the time of extraction.
• Surgical site free of active infections.
• Patients free from systemic diseases that may affect the healing process.
• Patients without known allergy for melatonin, local anesthetic agents, amoxicillin, or acetaminophen (paracetamol ) .

You may not qualify if:

• Heavy smokers (\>cigarettes / day) .
• Pregnant patients.
• Patients with local infections ('e.g pericoronitis) .
• Patients who used melatonin for more than 6 months prior to the study.
• Patients with poor oral hygiene or active periodontal disease.
• Patients with limited mouth opening
• Surgical procedures exceeding 30 minutes.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hyaluronic Acid; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator , Department of Oral and Maxillofacial Surgery , Faculty of Dentistry , Kafrelsheikh University

Model Details: participants are randomly assigned to two parallel groups . the test group receives a hyaluronic acid and melatonin mixture applied to the extraction socket using a gel foam carrier , while the control group receives gel foam only .

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start: July 22, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

EG (1)