The Application of Hyaluronic Acid on Teeth Bone Healing. Hyaluronic Acid Which is Widely Used in Medicine for Joint, Eye Care, Wound HealingNCT07318298
Effect of Injectable Hyaluronic Acid (HYADENT BG (HA)) on Bone Healing in Extraction Sockets
A study testing Surgical extraction of wisdom teeth and bone biobsy in people with The Application of Hyaluronic Acid on Teeth Bone Healing. Hyaluronic Acid Which is Widely Used in Medicine for Joint, Eye Care, Wound Healing, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- The Application of Hyaluronic Acid on Teeth Bone Healing. Hyaluronic Acid Which is Widely Used in Medicine for Joint, Eye Care, Wound Healing
- What is being tested?
- Surgical extraction of wisdom teeth and bone biobsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJordan
- Study dates
- 1 Aug 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Current smoker
- Use of anticoagulant therapy
- Any condition that, in the investigator's judgment, may interfere with healing or study outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Higher specialty training center
Irbid, 11196
rola Habashneh, Professor, 0096227201000, raalhabashneh@just.edu.jo
About this study
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.
Read the detailed description
This study is designed as a prospective, randomized, controlled clinical trial with a split-mouth design to assess the effect of topical hyaluronic acid on postoperative pain and alveolar socket bone healing following surgical extraction of mandibular third molars. The study will be conducted at the Oral and Maxillofacial Surgery and Preventive Dentistry clinics, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.
A total of 20 patients requiring bilateral surgical extraction of mandibular third molars will be enrolled. All participants will receive verbal and written information regarding the study procedures, and written informed consent will be obtained prior to participation. Randomization will be performed using a closed-envelope method. In each patient, one extraction site will be randomly allocated to receive hyaluronic acid gel combined with a collagen sponge (test site), while the contralateral site will receive a collagen sponge alone (control site).
The hyaluronic acid used in this study is a low-molecular weight sodium hyaluronate gel (Hyadent®, BioScience GmbH, Ransbach-Baumbach, Germany), supplied in sterile 1 mL syringes with blunt angulated cannulas. Each syringe contains sodium hyaluronate (14.0 mg), sodium chloride (6.9 mg), and water for injection. The formulation has modified viscosity and a short resorption time, allowing rapid absorption by the surrounding tissues.
All surgical procedures will be performed by a single experienced oral surgeon under standardized conditions. Preoperative evaluation includes medical and dental history, clinical examination, and panoramic radiography. Local anesthesia will be administered using an inferior alveolar nerve block with buccal infiltration of 2% lidocaine with 1:100,000 epinephrine. A standardized mucoperiosteal envelope flap will be raised for all procedures. Bone removal and tooth sectioning will be carried out when necessary using a low-speed handpiece under copious sterile saline irrigation.
After tooth removal, hyaluronic acid gel will be placed into the extraction socket at the test site and covered with a collagen sponge. Control sites will receive a collagen sponge alone. Primary closure will be achieved using 3-0 silk sutures. All patients will receive standardized postoperative instructions and medications. Sutures will be removed on postoperative day seven.
Postoperative pain 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: 12 hours after surgery (postoperative day 1), postoperative day 3, and postoperative day 7.
Radiographic assessment of socket healing will be performed using orthopantomogram (OPG) imaging in a randomly selected subgroup of participants approximately eight weeks after extraction. Radiographs will be obtained using standardized exposure parameters and processed under controlled conditions to ensure consistency.
Histological evaluation of socket healing will be conducted six weeks after extraction. Core biopsies will be obtained from both extraction sites under local anesthesia without flap reflection using a 3 mm diameter graded trephine bur. Harvested specimens will be fixed in formalin, decalcified, processed, and stained with hematoxylin and eosin. Digital images will be analyzed using image analysis software to calculate the percentage of woven bone within predefined regions of interest.
Statistical analysis will be performed using Statistical Package for the Social Sciences (SPSS) software. Descriptive statistics will be calculated for all variables. Comparative analyses will be conducted to evaluate differences in postoperative pain and woven bone formation between test and control sites, as well as changes in pain intensity over time.
- Being tested
- Surgical extraction of wisdom teeth, bone biobsy
- Keywords
- hyauronic acid, wisdom teeth extraction, bone healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical extraction of wisdom teethProcedure or surgery
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
bone biobsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| placebo extraction side | Placebo comparator | Surgical extraction of wisdom tooth with placebo administration inside the extraction site using collagen sponge Receives: 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 Receives: Procedure: Surgical extraction of wisdom teeth; Procedure: bone biobsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks after tooth extraction. units of measure is percentage of woven bone area (%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Aug 2024
- Primary completion26 Feb 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Application of Hyaluronic Acid on Teeth Bone Healing. Hyaluronic Acid Which is Widely Used in Medicine for Joint, Eye Care, Wound HealingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- application of Hyaluronic acid
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rola Habashneh, Professor, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318298
- Sponsor's protocol ID
- 35/175/2024
- Other IDs
- 644/2024
- Status last verified
- Jan 2026
- First submitted
- 25 Aug 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the participants collected are clinical and we should take their consent for any future studies. As our IRB approval is limited to this study, we cant share these data.
Publications
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.
PubMed 37963982
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Injectable Hyaluronic Acid (HYADENT BG (HA)) on Bone Healing in Extraction Sockets
- ClinicalTrials.gov ID
- NCT07318298
- Acronym / sponsor ID
- 35/175/2024
- Keywords
- hyauronic acid, wisdom teeth extraction, bone healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 26 Feb 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 5 Jan 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.
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.
Detailed description
This study is designed as a prospective, randomized, controlled clinical trial with a split-mouth design to assess the effect of topical hyaluronic acid on postoperative pain and alveolar socket bone healing following surgical extraction of mandibular third molars. The study will be conducted at the Oral and Maxillofacial Surgery and Preventive Dentistry clinics, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.
A total of 20 patients requiring bilateral surgical extraction of mandibular third molars will be enrolled. All participants will receive verbal and written information regarding the study procedures, and written informed consent will be obtained prior to participation. Randomization will be performed using a closed-envelope method. In each patient, one extraction site will be randomly allocated to receive hyaluronic acid gel combined with a collagen sponge (test site), while the contralateral site will receive a collagen sponge alone (control site).
The hyaluronic acid used in this study is a low-molecular weight sodium hyaluronate gel (Hyadent®, BioScience GmbH, Ransbach-Baumbach, Germany), supplied in sterile 1 mL syringes with blunt angulated cannulas. Each syringe contains sodium hyaluronate (14.0 mg), sodium chloride (6.9 mg), and water for injection. The formulation has modified viscosity and a short resorption time, allowing rapid absorption by the surrounding tissues.
All surgical procedures will be performed by a single experienced oral surgeon under standardized conditions. Preoperative evaluation includes medical and dental history, clinical examination, and panoramic radiography. Local anesthesia will be administered using an inferior alveolar nerve block with buccal infiltration of 2% lidocaine with 1:100,000 epinephrine. A standardized mucoperiosteal envelope flap will be raised for all procedures. Bone removal and tooth sectioning will be carried out when necessary using a low-speed handpiece under copious sterile saline irrigation.
After tooth removal, hyaluronic acid gel will be placed into the extraction socket at the test site and covered with a collagen sponge. Control sites will receive a collagen sponge alone. Primary closure will be achieved using 3-0 silk sutures. All patients will receive standardized postoperative instructions and medications. Sutures will be removed on postoperative day seven.
Postoperative pain 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: 12 hours after surgery (postoperative day 1), postoperative day 3, and postoperative day 7.
Radiographic assessment of socket healing will be performed using orthopantomogram (OPG) imaging in a randomly selected subgroup of participants approximately eight weeks after extraction. Radiographs will be obtained using standardized exposure parameters and processed under controlled conditions to ensure consistency.
Histological evaluation of socket healing will be conducted six weeks after extraction. Core biopsies will be obtained from both extraction sites under local anesthesia without flap reflection using a 3 mm diameter graded trephine bur. Harvested specimens will be fixed in formalin, decalcified, processed, and stained with hematoxylin and eosin. Digital images will be analyzed using image analysis software to calculate the percentage of woven bone within predefined regions of interest.
Statistical analysis will be performed using Statistical Package for the Social Sciences (SPSS) software. Descriptive statistics will be calculated for all variables. Comparative analyses will be conducted to evaluate differences in postoperative pain and woven bone formation between test and control sites, as well as changes in pain intensity over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- application of Hyaluronic acid
| Arm | Type | Receives |
|---|---|---|
| placebo extraction side | Placebo comparator | Procedure: Surgical extraction of wisdom teeth, Procedure: bone biobsySurgical extraction of wisdom tooth with placebo administration inside the extraction site using collagen sponge |
| experimental extraction side | Experimental | Procedure: Surgical extraction of wisdom teeth, Procedure: bone biobsySurgical extraction of wisdom tooth with placebo administration inside the extraction site using hyaluronic acid gel |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Surgical extraction of wisdom teethA 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 | Procedure or surgery | experimental extraction side, placebo extraction side |
| bone biobsyAfter 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. | Procedure or surgery | experimental extraction side, placebo extraction side |
Primary outcome
Postoperative Pain Intensity
Time frame: 12 hours (postoperative day 1), postoperative day 3, and postoperative day 7. Units of measure is VAS score (1-10).
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.
Alveolar Socket Bone Healing
Time frame: 6 weeks after tooth extraction. units of measure is percentage of woven bone area (%)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 37963982Domic 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.
- Individual participant dataSharing planned: No. The data of the participants collected are clinical and we should take their consent for any future studies. As our IRB approval is limited to this study, we cant share these data.
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.
Rola Habashneh, Professor study chair
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical extraction of wisdom teeth and bone biobsy in people with The Application of Hyaluronic Acid on Teeth Bone Healing. Hyaluronic Acid Which is Widely Used in Medicine for Joint, Eye Care, Wound Healing, run by Jordan University of Science and Technology at 1 site in Jordan.
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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Jan 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 Jordan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamimi (00962795036670, zztamimi@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 12 hours (postoperative day 1), postoperative day 3, and postoperative day 7. Units of measure is VAS score (1-10).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07318298, which also lists 1 linked publication.
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 28 Jan 2026.