Effect of Injectable Hyaluronic Acid (HYADENT BG (HA)) on Bone Healing in Extraction Sockets

NCT07318298 | Recruiting

• 2 other identifiers: 35/175/2024644/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

The Application of Hyaluronic Acid on Teeth Bone Healing. Hyaluronic Acid Which is Widely Used in Medicine for Joint, Eye Care, Wound Healing

Keywords

hyauronic acid, wisdom teeth extraction, bone healing

Outcome Measures

Primary Outcomes (2)

• 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.

  12 hours (postoperative day 1), postoperative day 3, and postoperative day 7. Units of measure is VAS score (1-10).

• 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.

  6 weeks after tooth extraction. units of measure is percentage of woven bone area (%)

Other Outcomes (1)

• Radiographic Assessment of Socket Healing

  Preoperative baseline and 6-8 weeks post-extraction

Study Arms (2)

placebo extraction side

PLACEBO COMPARATOR

Surgical extraction of wisdom tooth with placebo administration inside the extraction site using collagen sponge

Procedure: Surgical extraction of wisdom teeth; Procedure: bone biobsy

experimental extraction side

EXPERIMENTAL

Surgical extraction of wisdom tooth with placebo administration inside the extraction site using hyaluronic acid gel

Procedure: Surgical extraction of wisdom teeth; Procedure: bone biobsy

Interventions

Surgical extraction of wisdom teeth PROCEDURE

A 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

experimental extraction side; placebo extraction side

bone biobsy PROCEDURE

After 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.

experimental extraction side; placebo extraction side

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Higher specialty training center

Irbid, 11196, Jordan

RECRUITING

Related Publications (1)

• Domic D, Bertl K, Lang T, Pandis N, Ulm C, Stavropoulos A. Hyaluronic acid in tooth extraction: a systematic review and meta-analysis of preclinical and clinical trials. Clin Oral Investig. 2023 Dec;27(12):7209-7229. doi: 10.1007/s00784-023-05227-4. Epub 2023 Nov 15.

  PMID: 37963982 BACKGROUND

Study Officials

• Rola Habashneh, Professor

  Jordan University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Tamimi

CONTACT

00962795036670; zztamimi@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: application of Hyaluronic acid

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: January 5, 2026
• Study Start: August 1, 2024
• Primary Completion: February 26, 2026
• Study Completion: April 30, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)