Effect of Injectable Hyaluronic Acid (HYADENT BG (HA)) on Bone Healing in Extraction Sockets (NCT07318298) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Injectable Hyaluronic Acid (HYADENT BG (HA)) on Bone Healing in Extraction Sockets
Jordan20 participantsStarted 2024-08-01
Plain-language summary
Complications such as postoperative pain and delayed socket healing are relatively common following surgical extraction of mandibular third molars. Various biomaterials have been investigated to enhance wound healing and reduce postoperative morbidity. Hyaluronic acid (HA) has demonstrated anti-inflammatory and regenerative properties that may improve both soft and hard tissue healing.
The aim of this study is to evaluate the effect of topical hyaluronic acid on postoperative pain and alveolar socket bone healing following surgical extraction of mandibular third molars. A prospective, randomized, controlled clinical trial with a split-mouth design will be conducted. Twenty patients requiring bilateral mandibular third molar surgical extraction will be enrolled. In each patient, one extraction socket will receive hyaluronic acid combined with a collagen sponge, while the contralateral socket will receive a collagen sponge alone, according to random allocation. Postoperative pain will be assessed using a visual analogue scale, and socket healing will be evaluated radiographically and histologically.
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:
Male and female participants aged 18 to 35 years
Presence of bilateral impacted mandibular third molars classified as Pell and Gregory Class II, Position B
Classified as American Society of Anesthesiologists (ASA) Physical Status I
Absence of active local infection at the surgical site (e.g., no swelling, trismus, hyperthermia)
Ability to maintain adequate oral hygiene
Ability to understand and provide written informed consent
Ability to read and understand Arabic or English
Willingness to comply with study procedures and follow-up visits
Exclusion Criteria:
History of systemic diseases such as diabetes mellitus, hypertension, gastric ulcer, or other significant medical conditions
Presence of severe or chronic illness requiring frequent hospitalization
Pregnant or breastfeeding individuals
History of cognitive or motor impairment that may interfere with study participation
Use of anti-inflammatory or analgesic medications within two weeks before surgery
Known allergy or hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs)
Current smoker
Use of anticoagulant therapy
Any condition that, in the investigator's judgment, may interfere with healing or study outcomes
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
Postoperative Pain Intensity
Timeframe: 12 hours (postoperative day 1), postoperative day 3, and postoperative day 7. Units of measure is VAS score (1-10).
2
Alveolar Socket Bone Healing
Timeframe: 6 weeks after tooth extraction. units of measure is percentage of woven bone area (%)
Trial details
NCT IDNCT07318298
SponsorJordan University of Science and Technology