The Effect of Topical Application of Hyaluronic Acid and Melatonin Mixture Following Surgical Ext… (NCT07735806) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Topical Application of Hyaluronic Acid and Melatonin Mixture Following Surgical Extraction of Impacted Mandibular Third Molars .
Egypt40 participantsStarted 2024-07-22
Plain-language 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
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Alveolar bone density changes after surgical extraction of impacted mandibular third molars .
Timeframe: Baseline ( within 1 week after surgery ) and 6 months after surgery .