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NCT Number: NCT07735806

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

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

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Key information

Conditions

Impacted Mandibular Third Molar Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Kafrelsheikh University

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

About this study

Impacted mandibular third molars are the most frequently impacted teeth and their surgical extraction is one of the most common procedures performed in oral and maxillofacial surgery. Despite being a routine procedure, surgical extraction is commonly associated with postoperative pain, facial swelling, limited mouth opening, and delayed bone healing, which may negatively affect patients' quality of life during the recovery period.

Several approaches have been investigated to minimize postoperative complications and improve tissue healing. Hyaluronic acid is a naturally occurring glycosaminoglycan with well-established anti-inflammatory, bacteriostatic, and wound-healing properties. It promotes tissue repair by enhancing granulation tissue formation, angiogenesis, and re-epithelialization. In oral surgery, topical hyaluronic acid has shown promising results in reducing postoperative inflammation and improving healing following mandibular third molar extraction.

Melatonin is an endogenous hormone with potent antioxidant, anti-inflammatory, and osteogenic properties. It reduces oxidative stress and inflammatory mediators while stimulating osteoblast activity and bone formation. Although melatonin has demonstrated beneficial effects on bone regeneration and tissue healing, evidence regarding the local application of melatonin following impacted mandibular third molar surgery remains limited.

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 or gel foam alone following surgical extraction. The clinical and radiographic outcomes of both groups will be compared to determine whether this combined topical therapy enhances postoperative recovery and bone healing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 ) .

Exclusion criteria

  • 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.

Treatment and study plan

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 .

Gel foam

Other

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

Primary outcomes

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

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

    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 .

Secondary outcomes

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

    Time frame: Postoperative days 1 , 3 , and 7

    Pain intensity is assessed using a 10-point Visual Analog Scale ( VAS) , where 0 indicates no pain and 10 indicates the most severe pain .

  2. Maximum Mouth Opening ( MMO) after surgery

    Time frame: Preoperative baseline and postoperative days 1,3, and 7

    Maximum mouth opening is measured in millimeters using a manual caliper as the distance between the maxillary and mandibular central incisors during maximum mouth opening .

  3. Postoperative facial swelling

    Time frame: Preoperative baseline and postoperative days 1,3, and 7

    Facial swelling is assessed by measuring changes in facial dimensions using a flexible tape measure . vertical and horizontal facial measurements are recorded and the mean facial measurement is calculated . postoperative facial edema is calculated as a percentage change from baseline measurements .

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

The Effect of Topical Application of Hyaluronic Acid and Melatonin Mixture Following Surgical Extraction of Impacted Mandibular Third Molars ( A Randomized Clinical Trial )

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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