Impact MolarNCT07374536
Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes After Surgical Removal of Impacted Mandibular Third Molar
A study testing Melatonin gel in people with Impact Molar, run by Suez Canal University at 1 site in Egypt.
Trial summary
Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes after Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Impact Molar
- What is being tested?
- Melatonin gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 15 Aug 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Pregnant \& lactating women.
- Smoker patients.
- Patients with poor oral hygiene.
- Patients with bad oral habits as bruxism.
- Patients with periapical or peri coronal lesions.
- Patients with aggressive gingivitis or periodontitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes After Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study
Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes after Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study
Read the detailed description
of all impacted teeth. The frequency of impaction of the mandibular third molar ranges from 33% to 58.7%. A tooth is considered to be impacted when its eruption time has passed or when the eruption interferes with the normal functional occlusion with other teeth or the overlying bone or soft tissues in the oral cavity.
The surgical removal of an impacted third molar is an everyday procedure in oral surgery clinics. However, it is known to disturb the quality of life of the patient by restricting the ability to chew food, open the mouth, and speak. Furthermore, there is a danger of periodontal damage on the distal root of the adjacent molar which could affect healing, 43% of the patients had a periodontal pocket depth of 7 mm or more at the distal root of the mandibular second molar 2 years post extraction of an impacted mandibular third molar.
The healing of periodontal defects related to the distal root of the adjacent molar may be compromised by intra-bony defects and bone loss after the removal of the impacted tooth. Alternative strategies, such as different flap designs, soft-tissue suturing, socket preservation, and tissue regeneration techniques with autologous bone, allografts, xenografts, or alloplastic grafts, have been proposed to prevent periodontal defects and physiological bone resorption after the surgical extraction of the mandibular third molar.
Melatonin is a growth hormone secreted mainly by the pineal gland and other structures, such as the retina, skin, gastrointestinal tract, lymphocytes, and bone marrow.It has antioxidant and anti inflammatory properties. It inhibits the production of reactive oxidants by reducing the expression of cyclooxygenase-2 and prostaglandin. In addition, it attracts polymorphonuclear cells to the site of injury.
- Conditions
- Impact Molar
- Being tested
- Control, Melatonin gel
- Keywords
- Impaction, Melatonin, Mandibular 3rd Molars, Radiographic evaluation, Clinical Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDiagnostic test
the extraction socket will be left empty followed by suture of the socket after extraction
Melatonin gelDietary supplement
3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction
| Study group | Role | What they receive |
|---|---|---|
| Control without Melatonin | Placebo comparator | (the extraction socket will be left empty followed by suture of the socket after extraction Receives: Diagnostic Test: Control; Dietary Supplement: Melatonin gel |
| Study with Melatonin | Experimental | 3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction Receives: Diagnostic Test: Control; Dietary Supplement: Melatonin gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Assess relative bone density at the center of the extracted socket using digital periapical radiograph in the center of the socket.
Measured: 1 and 4 months postoperatively
Secondary outcomes (4)
Post-operative pain levels
Post-operative pain levels by VAS (Visual Analog Scale) Minimum Score: 0 (no pain) Maximum Score: 10 (severe pain that completely prevent daily activities)
Measured: 1, 3 and 7 days Postoperatively
Measure Edema scale
Measure Edema scale using flexible ruler (It depends on the patient's own facial measurements and returning to normal measurements).
Measured: 1, 3 and 7 days Postoperatively
Measure Maximal Mouth opening (MMO)
Measure Maximal Mouth opening (MMO) using digital caliper.
Measured: 1, 3 and 7 days Postoperatively
Measure the incidence of post-operative complications
Measure the incidence of post-operative complications (e.g., dry socket, infection) in both groups.
Measured: 1, 3 and 7 days Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Sep 2025
- Primary completion15 Jun 2026
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact MolarStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374536
- Sponsor's protocol ID
- 2025/1006
- Status last verified
- Jul 2026
- First submitted
- 20 Jan 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes After Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07374536
- Acronym / sponsor ID
- 2025/1006
- Conditions
- Impact Molar
- Keywords
- Impaction, Melatonin, Mandibular 3rd Molars, Radiographic evaluation, Clinical Evaluation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 28 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.
Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes after Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study
Detailed description
of all impacted teeth. The frequency of impaction of the mandibular third molar ranges from 33% to 58.7%. A tooth is considered to be impacted when its eruption time has passed or when the eruption interferes with the normal functional occlusion with other teeth or the overlying bone or soft tissues in the oral cavity.
The surgical removal of an impacted third molar is an everyday procedure in oral surgery clinics. However, it is known to disturb the quality of life of the patient by restricting the ability to chew food, open the mouth, and speak. Furthermore, there is a danger of periodontal damage on the distal root of the adjacent molar which could affect healing, 43% of the patients had a periodontal pocket depth of 7 mm or more at the distal root of the mandibular second molar 2 years post extraction of an impacted mandibular third molar.
The healing of periodontal defects related to the distal root of the adjacent molar may be compromised by intra-bony defects and bone loss after the removal of the impacted tooth. Alternative strategies, such as different flap designs, soft-tissue suturing, socket preservation, and tissue regeneration techniques with autologous bone, allografts, xenografts, or alloplastic grafts, have been proposed to prevent periodontal defects and physiological bone resorption after the surgical extraction of the mandibular third molar.
Melatonin is a growth hormone secreted mainly by the pineal gland and other structures, such as the retina, skin, gastrointestinal tract, lymphocytes, and bone marrow.It has antioxidant and anti inflammatory properties. It inhibits the production of reactive oxidants by reducing the expression of cyclooxygenase-2 and prostaglandin. In addition, it attracts polymorphonuclear cells to the site of injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control without Melatonin | Placebo comparator | Diagnostic Test: Control, Dietary Supplement: Melatonin gel(the extraction socket will be left empty followed by suture of the socket after extraction |
| Study with Melatonin | Experimental | Diagnostic Test: Control, Dietary Supplement: Melatonin gel3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Pregnant \& lactating women.
- Smoker patients.
- Patients with poor oral hygiene.
- Patients with bad oral habits as bruxism.
- Patients with periapical or peri coronal lesions.
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 |
|---|---|---|
| Controlthe extraction socket will be left empty followed by suture of the socket after extraction | Diagnostic test | Control without Melatonin, Study with Melatonin |
| Melatonin gel3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction | Dietary supplement | Control without Melatonin, Study with Melatonin |
Primary outcome
Bone density
Time frame: 1 and 4 months postoperatively
Assess relative bone density at the center of the extracted socket using digital periapical radiograph in the center of the socket.
4 secondary outcomes
Post-operative pain levels
Time frame: 1, 3 and 7 days Postoperatively
Measure Edema scale
Time frame: 1, 3 and 7 days Postoperatively
Measure Maximal Mouth opening (MMO)
Time frame: 1, 3 and 7 days Postoperatively
Measure the incidence of post-operative complications
Time frame: 1, 3 and 7 days Postoperatively
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 13 Jul 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 Melatonin gel in people with Impact Molar, run by Suez Canal 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 0 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 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. 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?
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?
Bone density (time frame: 1 and 4 months postoperatively). 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 13 Jul 2026.