An interventional study of 0.2% Hyaluronic Acid Gel in Impacted Mandibular Third Molar Extraction, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Supportive care
Surgical removal of impacted lower wisdom teeth can cause pain, facial swelling, difficulty opening the mouth, and discomfort during wound healing. This study evaluates whether placing a gel containing 0.2% hyaluronic acid into the tooth socket immediately after removal improves recovery compared with standard care alone.
Adults requiring removal of similarly impacted lower wisdom teeth on both sides of the mouth undergo two separate operations at least 28 days apart. Each participant receives hyaluronic acid gel in one socket, while the other socket receives no additional material. Both sockets are closed with stitches. The order of surgery and the side receiving the gel are randomly assigned. Participants are not told which side receives the gel.
Recovery is compared between the two sides of each participant. Pain and perceived swelling are recorded on days 1, 3, and 7 after each operation. Facial measurements and mouth opening are assessed before surgery and on days 3 and 7. Gum healing is assessed on days 3 and 7, and any complications are recorded. Participants receive the same routine postoperative care after both operations.
This single-center, randomized, controlled, participant-blinded trial uses a split-mouth design to evaluate a single intra-socket application of 0.2% hyaluronic acid gel following surgical removal of impacted mandibular third molars. The study is conducted at the Specialized Dental Clinic, University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam.
Each participant requires bilateral removal of impacted mandibular third molars with comparable surgical difficulty. The teeth must have the same Pell and Gregory class and depth, with an angulation difference of no more than 15 degrees. The split-mouth design allows each participant to serve as their own control.
Randomization is performed by drawing lots to determine the side operated on first and whether the first extraction socket receives hyaluronic acid gel or no additional material. The contralateral socket receives the alternative treatment during the second operation, performed at least 28 days later. Participants are blinded to treatment allocation; the surgeon and outcome examiner are not blinded.
A single experienced surgeon performs all extractions using a standardized surgical technique under local anesthesia. After tooth removal, socket curettage, smoothing of bone edges, and irrigation with sterile saline, 2 mL of 0.2% hyaluronic acid gel (Gengigel, Ricerfarma, Milan, Italy) is placed directly into the intervention socket immediately before closure. No carrier material is used. The control socket is allowed to fill with a blood clot without placement of an additional material. Both sites are closed with interrupted 3-0 silk sutures. Postoperative medications and instructions are standardized for both procedures.
Patient-reported pain and subjective swelling are recorded on postoperative days 1, 3, and 7 using six-level scales ranging from 0 to 5, with higher scores indicating greater symptom severity. Objective swelling is assessed at baseline and on days 3 and 7 using three facial distances: tragus to soft-tissue pogonion, tragus to labial commissure, and lateral canthus to gonial angle. Swelling is calculated as the postoperative distance minus the baseline distance.
Maximum mouth opening is measured between the incisal edges of the same upper and lower central incisors at baseline and on days 3 and 7, and is also expressed as a percentage of baseline. Soft-tissue healing is assessed on days 3 and 7 using the Landry healing index, ranging from 1 (very poor) to 5 (excellent). Surgical duration and adverse events, including alveolar osteitis, surgical-site infection, prolonged bleeding, and local allergic reactions, are recorded.
Between-treatment comparisons account for the paired observations within each participant. Repeated assessments are used to compare the course of postoperative recovery between the two treatments.
University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 121 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
In each participant, one randomly assigned mandibular third molar extraction socket receives 2 mL of 0.2% hyaluronic acid gel immediately after surgical extraction and socket irrigation, before closure with interrupted 3-0 silk sutures. The gel is applied once, without a carrier material.
Other: 0.2% Hyaluronic Acid Gel
The contralateral mandibular third molar extraction socket in the same participant receives no hyaluronic acid gel or other additional socket material. After surgical extraction and socket irrigation, the socket is allowed to fill with a blood clot and is closed with interrupted 3-0 silk sutures. The same standard postoperative care is provided. The two surgical procedures are performed at least 28 days apart.
A single application of 2 mL of 0.2% hyaluronic acid gel (Gengigel, Ricerfarma, Milan, Italy) is delivered directly into the extraction socket after surgical removal of the impacted mandibular third molar and irrigation with sterile saline, immediately before suturing. No carrier material is used, and no repeat application is performed.
Postoperative pain
Participants rate pain on a six-level descriptive scale ranging from 0 to 5: 0, no pain; 1, pain not noticed unless attended to; 2, pain noticed while concentrating on other tasks; 3, marked discomfort but able to continue daily activities; 4, pain requiring cessation of all activities; and 5, pain requiring cessation of all activities and bed rest. Higher scores indicate greater pain severity. Assessments are completed in the evening.
Time frame: Postoperative days 1, 3, and 7 after each surgical procedure.
Subjective swelling
Participants rate perceived swelling on a six-level descriptive scale ranging from 0 (no swelling) to 5 (marked swelling with limited mouth opening). Intermediate categories reflect the degree of interference with chewing and swallowing. Higher scores indicate greater perceived swelling. Assessments are completed in the evening
Time frame: Postoperative days 1, 3, and 7 after each surgical procedure.
Soft-tissue healing
Healing of the soft tissue at the extraction site is assessed using the Landry healing index. The index evaluates tissue color, bleeding on palpation, granulation tissue, epithelialization of incision margins, and suppuration. Scores range from 1 (very poor healing) to 5 (excellent healing), with higher scores indicating better healing.
Time frame: Postoperative days 3 and 7 after each surgical procedure.
Maximum Mouth Opening
Maximum mouth opening is measured in millimeters using a digital caliper between the incisal edges of the same upper and lower central incisors. Postoperative measurements are compared with the preoperative baseline for each surgical procedure and are also expressed as a percentage of baseline. Lower postoperative values indicate greater limitation of mouth opening.
Time frame: Preoperatively and on postoperative days 3 and 7 after each surgical procedure.
Objective swelling
Facial swelling is assessed using three distances measured with a flexible tape: segment A, tragus to soft-tissue pogonion; segment B, tragus to labial commissure; and segment C, lateral canthus to gonial angle. Measurements are obtained with the teeth in occlusion, rounded to the nearest millimeter, and reported in centimeters. Change is calculated separately for each segment as the postoperative distance minus its preoperative baseline value. Larger positive changes indicate greater swelling.
Time frame: Baseline before each surgical procedure and postoperative days 3 and 7.
Plan to share: Yes
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