Impacted Mandibular Third Molar ExtractionNCT07890272
Hyaluronic Acid Gel After Impacted Mandibular Third Molar Surgery
A study testing 0.2% Hyaluronic Acid Gel in people with Impacted Mandibular Third Molar Extraction, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction
- What is being tested?
- 0.2% Hyaluronic Acid Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Indication for surgical removal of bilateral, symmetrically impacted mandibular third molars.
- Both mandibular third molars have the same Pell and Gregory class and depth, with an angulation difference of no more than 15 degrees.
Who cannot join
- Acute inflammation or infection at either mandibular third molar site.
- Systemic conditions contraindicating oral surgery.
- Known allergy to local anesthetics.
- Pregnancy or breastfeeding.
- Alcohol dependence, long-term smoking, or poor oral hygiene.
- Clinical or radiographic findings suggestive of a cystic lesion or a benign or malignant neoplasm at or near either extraction site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-socket Hyaluronic Acid Gel After Impacted Mandibular Third Molar Surgery: A Split-Mouth Randomized Clinical Trial
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.
Read the detailed description
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.
- Being tested
- 0.2% Hyaluronic Acid Gel
- Keywords
- hyaluronic acid, third molar extraction, healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.2% Hyaluronic Acid GelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid | Experimental | 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. Receives: Other: 0.2% Hyaluronic Acid Gel |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Postoperative days 3 and 7 after each surgical procedure.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline before each surgical procedure and postoperative days 3 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Sep 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- split-mouth design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lam Cu Phong, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890272
- Sponsor's protocol ID
- 4278/QĐ-ĐHYD
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-socket Hyaluronic Acid Gel After Impacted Mandibular Third Molar Surgery: A Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07890272
- Acronym / sponsor ID
- 4278/QĐ-ĐHYD
- Keywords
- hyaluronic acid, third molar extraction, healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid | Experimental | Other: 0.2% Hyaluronic Acid GelIn 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Indication for surgical removal of bilateral, symmetrically impacted mandibular third molars.
- Both mandibular third molars have the same Pell and Gregory class and depth, with an angulation difference of no more than 15 degrees.
Key exclusion criteria (6 listed)
- Acute inflammation or infection at either mandibular third molar site.
- Systemic conditions contraindicating oral surgery.
- Known allergy to local anesthetics.
- Pregnancy or breastfeeding.
- Alcohol dependence, long-term smoking, or poor oral hygiene.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.2% Hyaluronic Acid GelA 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. | Other | Hyaluronic Acid |
Primary outcome
Postoperative pain
Time frame: Postoperative days 1, 3, and 7 after each surgical procedure.
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.
Subjective swelling
Time frame: Postoperative days 1, 3, and 7 after each surgical procedure.
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
Soft-tissue healing
Time frame: Postoperative days 3 and 7 after each surgical procedure.
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.
2 secondary outcomes
Maximum Mouth Opening
Time frame: Preoperatively and on postoperative days 3 and 7 after each surgical procedure.
Objective swelling
Time frame: Baseline before each surgical procedure and postoperative days 3 and 7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.2% Hyaluronic Acid Gel in people with Impacted Mandibular Third Molar Extraction, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Postoperative days 1, 3, and 7 after each surgical procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.