Impacted Mandibular Third MolarNCT07735806
The Effect of Topical Application of Hyaluronic Acid and Melatonin Mixture Following Surgical Extraction of Impacted Mandibular Third Molars .
A study testing Hyaluronic acid and Melatonin mixture and Gel foam in people with Impacted Mandibular Third Molar, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate the clinical and radiographical effects of the application of a mixture of hyaluronic acid and melatonin after surgical extraction of impacted mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Impacted Mandibular Third Molar
- What is being tested?
- Hyaluronic acid and Melatonin mixture and Gel foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2024to 2 Aug 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-35 years.
- patients requiring surgical extraction of impacted mandibular third molars classified as Pell and Gregory class II, position B, irrespectiver of the impaction type.
- Patients with normal moueh opening at the time of extraction.
- Surgical site free of active infections.
- Patients free from systemic diseases that may affect the healing process.
- Patients without known allergy for melatonin, local anesthetic agents, amoxicillin, or acetaminophen (paracetamol ) .
Who cannot join
- Heavy smokers (>cigarettes / day) .
- Pregnant patients.
- Patients with local infections ('e.g pericoronitis) .
- Patients who used melatonin for more than 6 months prior to the study.
- Patients with poor oral hygiene or active periodontal disease.
- Patients with limited mouth opening
- Surgical procedures exceeding 30 minutes.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
About this study
Official title: The Effect of Topical Application of Hyaluronic Acid and Melatonin Mixture Following Surgical Extraction of Impacted Mandibular Third Molars ( A Randomized Clinical Trial )
This randomized controlled clinical trial aims to evaluate the clinical and radiographical effects of the application of a mixture of hyaluronic acid and melatonin after surgical extraction of impacted mandibular third molars. Participants are randomly allocated to receive either gel foam loaded with a topical mixture of hyaluronic acid and melatonin ( intervention group ) or gel foam alone ( control group ) following surgical extraction. Clinical outcomes, including postoperative pain, facial swelling, and maximum mouth opening, are assessed on postoperative days 1, 3, and 7. Radiographic bone healing is evaluated using cone-beam computed tomography (CBCT), with a baseline scan obtained within one week after surgery and a follow-up scan performed 6 months postoperatively to assess changes in bone density. The clinical and radiographic outcomes of both groups are compared to determine whether the combined treatment improves postoperative healing following surgical extraction of impacted mandibular third molars
Read the detailed description
Impacted mandibular third molars are the most frequently impacted teeth and their surgical extraction is one of the most common procedures performed in oral and maxillofacial surgery. Despite being a routine procedure, surgical extraction is commonly associated with postoperative pain, facial swelling, limited mouth opening, and delayed bone healing, which may negatively affect patients' quality of life during the recovery period.
Several approaches have been investigated to minimize postoperative complications and improve tissue healing. Hyaluronic acid is a naturally occurring glycosaminoglycan with well-established anti-inflammatory, bacteriostatic, and wound-healing properties. It promotes tissue repair by enhancing granulation tissue formation, angiogenesis, and re-epithelialization. In oral surgery, topical hyaluronic acid has shown promising results in reducing postoperative inflammation and improving healing following mandibular third molar extraction.
Melatonin is an endogenous hormone with potent antioxidant, anti-inflammatory, and osteogenic properties. It reduces oxidative stress and inflammatory mediators while stimulating osteoblast activity and bone formation. Although melatonin has demonstrated beneficial effects on bone regeneration and tissue healing, evidence regarding the local application of melatonin following impacted mandibular third molar surgery remains limited.
This randomized controlled clinical trial aims to evaluate the clinical and radiographical effects of the application of a mixture of hyaluronic acid and melatonin after surgical extraction of impacted mandibular third molars. Participants are randomly allocated to receive either gel foam loaded with a topical mixture of hyaluronic acid and melatonin or gel foam alone following surgical extraction. The clinical and radiographic outcomes of both groups will be compared to determine whether this combined topical therapy enhances postoperative recovery and bone healing.
- Conditions
- Impacted Mandibular Third Molar
- Being tested
- Hyaluronic acid and Melatonin mixture, Gel foam
- Keywords
- Impacted mandibular third molar, Third molar extraction, Hyaluronic acid, Melatonin, Bone healing, Bone density, CBCT, Postoperative pain, Facial swelling, Maximum mouth opening
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid and Melatonin mixtureDrug
A topical mixture of 0.2 % hyaluronic acid gel combined with 3 mg melatonin is applied into the extraction socket following surgical extraction of impacted mandibular third molars using a gel foam carrier .
Gel foamOther
Gel foam is applied alone into the extraction socket following surgical extraction of mandibular third molars .
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid + Melatonin Group ( Experimental ) | Experimental | Participants receive a mixture of hyaluronic acid and melatonin into the extraction socket following surgical extraction of impacted mandibular third molars using gel foam as a carrier . Receives: Drug: Hyaluronic acid and Melatonin mixture |
| Gel foam control group ( control ) | Active comparator | Participants receive gel foam only applied into the extraction socket following surgical extraction of impacted mandibular third molars . Receives: Other: Gel foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar bone density changes after surgical extraction of impacted mandibular third molars .
Assessment of bone density within the extraction socket using cone beam computed tomography ( CBCT) . Bone density values expressed as Hounsfield units (HU) are measured at baseline and at 6 months postoperatively .
Measured: Baseline ( within 1 week after surgery ) and 6 months after surgery .
Secondary outcomes (3)
Postoperative pain intensity assessed by Visual Analog Scale (VAS).
Pain intensity is assessed using a 10-point Visual Analog Scale ( VAS) , where 0 indicates no pain and 10 indicates the most severe pain .
Measured: Preoperatively, and on postoperative days 1 , 3 , and 7
Maximum Mouth Opening ( MMO) after surgery
Maximum mouth opening is measured in millimeters using a manual caliper as the distance between the maxillary and mandibular central incisors during maximum mouth opening .
Measured: Preoperative baseline and postoperative days 1,3, and 7
Postoperative facial swelling
Facial swelling is assessed by measuring changes in facial dimensions using a flexible tape measure . vertical and horizontal facial measurements are recorded and the mean facial measurement is calculated . postoperative facial edema is calculated as a percentage change from baseline measurements .
Measured: Preoperative baseline and postoperative days 1,3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start22 Jul 2024
- Primary completion2 Aug 2026
- Study completion2 Aug 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 MolarStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- participants are randomly assigned to two parallel groups . the test group receives a hyaluronic acid and melatonin mixture applied to the extraction socket using a gel foam carrier , while the control group receives gel foam only .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Mohamed Hassan, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735806
- Sponsor's protocol ID
- KFSIRB200-170
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Application of Hyaluronic Acid and Melatonin Mixture Following Surgical Extraction of Impacted Mandibular Third Molars ( A Randomized Clinical Trial )
- ClinicalTrials.gov ID
- NCT07735806
- Acronym / sponsor ID
- KFSIRB200-170
- Conditions
- Impacted Mandibular Third Molar
- Keywords
- Impacted mandibular third molar, Third molar extraction, Hyaluronic acid, Melatonin, Bone healing, Bone density, CBCT, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 2 Aug 2026 (actual)
- Study completion
- 2 Aug 2026 (actual)
- First posted
- 30 Jul 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.
This randomized controlled clinical trial aims to evaluate the clinical and radiographical effects of the application of a mixture of hyaluronic acid and melatonin after surgical extraction of impacted mandibular third molars. Participants are randomly allocated to receive either gel foam loaded with a topical mixture of hyaluronic acid and melatonin ( intervention group ) or gel foam alone ( control group ) following surgical extraction. Clinical outcomes, including postoperative pain, facial swelling, and maximum mouth opening, are assessed on postoperative days 1, 3, and 7. Radiographic bone healing is evaluated using cone-beam computed tomography (CBCT), with a baseline scan obtained within one week after surgery and a follow-up scan performed 6 months postoperatively to assess changes in bone density. The clinical and radiographic outcomes of both groups are compared to determine whether the combined treatment improves postoperative healing following surgical extraction of impacted mandibular third molars
Detailed description
Impacted mandibular third molars are the most frequently impacted teeth and their surgical extraction is one of the most common procedures performed in oral and maxillofacial surgery. Despite being a routine procedure, surgical extraction is commonly associated with postoperative pain, facial swelling, limited mouth opening, and delayed bone healing, which may negatively affect patients' quality of life during the recovery period.
Several approaches have been investigated to minimize postoperative complications and improve tissue healing. Hyaluronic acid is a naturally occurring glycosaminoglycan with well-established anti-inflammatory, bacteriostatic, and wound-healing properties. It promotes tissue repair by enhancing granulation tissue formation, angiogenesis, and re-epithelialization. In oral surgery, topical hyaluronic acid has shown promising results in reducing postoperative inflammation and improving healing following mandibular third molar extraction.
Melatonin is an endogenous hormone with potent antioxidant, anti-inflammatory, and osteogenic properties. It reduces oxidative stress and inflammatory mediators while stimulating osteoblast activity and bone formation. Although melatonin has demonstrated beneficial effects on bone regeneration and tissue healing, evidence regarding the local application of melatonin following impacted mandibular third molar surgery remains limited.
This randomized controlled clinical trial aims to evaluate the clinical and radiographical effects of the application of a mixture of hyaluronic acid and melatonin after surgical extraction of impacted mandibular third molars. Participants are randomly allocated to receive either gel foam loaded with a topical mixture of hyaluronic acid and melatonin or gel foam alone following surgical extraction. The clinical and radiographic outcomes of both groups will be compared to determine whether this combined topical therapy enhances postoperative recovery and bone healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- participants are randomly assigned to two parallel groups . the test group receives a hyaluronic acid and melatonin mixture applied to the extraction socket using a gel foam carrier , while the control group receives gel foam only .
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid + Melatonin Group ( Experimental ) | Experimental | Drug: Hyaluronic acid and Melatonin mixtureParticipants receive a mixture of hyaluronic acid and melatonin into the extraction socket following surgical extraction of impacted mandibular third molars using gel foam as a carrier . |
| Gel foam control group ( control ) | Active comparator | Other: Gel foamParticipants receive gel foam only applied into the extraction socket following surgical extraction of impacted mandibular third molars . |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18-35 years.
- patients requiring surgical extraction of impacted mandibular third molars classified as Pell and Gregory class II, position B, irrespectiver of the impaction type.
- Patients with normal moueh opening at the time of extraction.
- Surgical site free of active infections.
- Patients free from systemic diseases that may affect the healing process.
Key exclusion criteria (7 listed)
- Heavy smokers (>cigarettes / day) .
- Pregnant patients.
- Patients with local infections ('e.g pericoronitis) .
- Patients who used melatonin for more than 6 months prior to the study.
- Patients with poor oral hygiene or active periodontal disease.
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 |
|---|---|---|
| Hyaluronic acid and Melatonin mixtureA topical mixture of 0.2 % hyaluronic acid gel combined with 3 mg melatonin is applied into the extraction socket following surgical extraction of impacted mandibular third molars using a gel foam carrier . | Drug | Hyaluronic Acid + Melatonin Group ( Experimental ) |
| Gel foamGel foam is applied alone into the extraction socket following surgical extraction of mandibular third molars . | Other | Gel foam control group ( control ) |
Primary outcome
Alveolar bone density changes after surgical extraction of impacted mandibular third molars .
Time frame: Baseline ( within 1 week after surgery ) and 6 months after surgery .
Assessment of bone density within the extraction socket using cone beam computed tomography ( CBCT) . Bone density values expressed as Hounsfield units (HU) are measured at baseline and at 6 months postoperatively .
3 secondary outcomes
Postoperative pain intensity assessed by Visual Analog Scale (VAS).
Time frame: Preoperatively, and on postoperative days 1 , 3 , and 7
Maximum Mouth Opening ( MMO) after surgery
Time frame: Preoperative baseline and postoperative days 1,3, and 7
Postoperative facial swelling
Time frame: Preoperative baseline and postoperative days 1,3, 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 8 Sep 2026.
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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 Hyaluronic acid and Melatonin mixture and Gel foam in people with Impacted Mandibular Third Molar, run by Kafrelsheikh University at 1 site in Egypt.
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 6 inclusion and 7 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 8 Sep 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 Egypt. 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?
Alveolar bone density changes after surgical extraction of impacted mandibular third molars . (time frame: Baseline ( within 1 week after surgery ) and 6 months after surgery .). 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 8 Sep 2026.