Effect of Injectable Hyaluronic Acid (HYADENT BG (HA)) on Bone Healing in Extraction Sockets
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorJordan University of Science and Technology
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Surgical extraction of wisdom teeth
Procedure/SurgeryA standardized surgical procedure was performed by a single experienced surgeon (ZA). Under strict aseptic conditions, an inferior alveolar nerve block with buccal infiltration, was given using lidocaine HCl 2% with epinephrine 1:100,000 (Cook-Waite, Rochester, NY). A mucoperiosteal envelope flap was utilized for all surgeries. Bone removal and tooth sectioning were performed as deemed necessary using a low-speed handpiece under copious saline irrigation. After tooth removal, HA gel (Hyadent) was placed inside the extraction socket and covered with collagen sponge in the test sockets, while only coverage with collagen sponge was placed in the control sockets. Subsequently, flap closure was achieved using 3-0 silk sutures
bone biobsy
Procedure/SurgeryAfter 6 weeks, core biopsies are taken from both sides. Under local anesthesia, the core biopsies sre taken without reflection of a flap, using a graded trephine bur (MCT, Korea) of 3 mm diameter (which is not invasive or having any complication) for later histological evaluation. Specimens harvested from each patient are fixed in 10% formalin, then decalcified using 10% hydrochloric acid. After processing, 5 micrometer sections are prepared and stained with hematoxylin and eosin stain (H\&E). Digital images are acquired from each section at a magnification of × 40. ImageJ 1.52a software (National Institute of Health, Bethesda, Maryland, USA) is used to calculate the percentage of woven bone area within selected regions of interest (ROI) in each image, utilizing the color thresholding feature. To ensure that measurements are valid, 3 measurements are made for each of the hard tissue and soft tissue components, and for the total area of the ROI in pixels.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: placebo extraction sidePlacebo comparator 2 interventions
Group B: experimental extraction sideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using a visual analogue scale (VAS) ranging from 1 (no pain) to 10 (worst pain imaginable). Participants will record pain scores at standardized time points following mandibular third molar extraction.
Time frame
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
Alveolar socket bone healing will be evaluated histologically by quantifying the percentage of woven bone formation within the extraction socket. Core biopsies will be obtained six weeks post-extraction and analyzed using digital histomorphometry. The percentage of woven bone area within predefined regions of interest will be calculated using ImageJ software.
Time frame
6 weeks after tooth extraction. units of measure is percentage of woven bone area (%)Other outcomes
1
Radiographic Assessment of Socket Healing
Radiographic socket healing will be assessed descriptively using orthopantomogram (OPG) imaging. Standardized radiographs will be obtained preoperatively and approximately six to eight weeks post-extraction to evaluate changes in socket radiodensity.
Time frame
Preoperative baseline and 6-8 weeks post-extractionSponsors and contacts
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Source ClinicalTrials.gov