Bone LossPhase 2NCT07921355
Melatonin in Posterior Mandible Extraction Socket
A Phase 2 study testing Melatonin group in people with Bone Loss, run by Cairo University.
Trial summary
This study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. It will include patients aged 18-30 years presenting with non-restorable mandibular molars indicated for extraction and delayed implant placement. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Bone Loss
- What is being tested?
- Melatonin group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 10 Nov 2027
- Phase
- Phase 2
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-30 years
- Presence of non-restorable mandibular molars indicated for extraction
- Patients with good general health
- Adequate oral hygiene
- Patients willing to undergo implant placement after 4 months
- Patients who provide informed consent
Who cannot join
- Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis)
- Patients receiving medications affecting bone metabolism (e.g., corticosteroids, bisphosphonates)
- Heavy smokers
- Presence of acute infection or pathological lesions at the extraction site
- Pregnant or lactating females
About this study
Official title: Effect of Local Melatonin Gel Versus Placebo Gel Application on Bone Regeneration in Mandibular Posterior Teeth Extraction Sockets With Radiographic and Histopathological Evaluation: A Randomized Clinical Trial
This study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. It will include patients aged 18-30 years presenting with non-restorable mandibular molars indicated for extraction and delayed implant placement.
Eligible patients will be randomly allocated into two equal groups:
Read more
- Group I (Intervention group): Extraction sockets will be filled with locally applied melatonin gel.
- Group II (Control group): Extraction sockets will be filled with placebo gel. All patients will undergo atraumatic tooth extraction under local anesthesia, followed by socket curettage, saline irrigation, application of the allocated gel, collagen membrane coverage, and primary wound closure.
Postoperative care will include standardized medications and oral hygiene instructions. Patients will be followed up clinically and radiographically. CBCT will be used to assess the primary outcome, which is the dimensional change in vertical alveolar bone height (ΔH). At 12 weeks, core biopsy specimens will be obtained for histopathological assessment of bone quality, including newly formed bone, bone maturation, trabecular architecture, and osteoblastic activity.
Sample size: The total sample size will be determined based on the primary outcome (ΔH), using an appropriate statistical power calculation, with equal allocation between the two groups. The final number of participants will be specified according to the statistician's sample size calculation.
- Conditions
- Bone Loss
- Being tested
- Melatonin group, Placebo group
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin groupDrug
Eligible patients will undergo atraumatic extraction of non-restorable mandibular molars under local anesthesia, followed by socket curettage and irrigation with sterile 0.9% saline.
The extraction socket will be filled with locally applied melatonin gel. A collagen membrane will then be adapted to cover the socket, followed by primary wound closure using interrupted sutures.
All participants will receive standardized postoperative medications and oral hygiene instructions. Clinical follow-up will be conducted at 3 days and 1 week postoperatively. At 12 weeks, CBCT examination will be performed to assess changes in vertical alveolar bone height (ΔH), followed by core biopsy for histopathological evaluation of bone qualit
Placebo groupDrug
Eligible patients will undergo atraumatic extraction of non-restorable mandibular molars under local anesthesia, followed by socket curettage and irrigation with sterile 0.9% saline.
The extraction socket will be filled with locally applied placebo gel. A collagen membrane will then be adapted to cover the socket, followed by primary wound closure using interrupted sutures.
All participants will receive standardized postoperative medications and oral hygiene instructions. Clinical follow-up will be conducted at 3 days and 1 week postoperatively. At 12 weeks, CBCT examination will be performed to assess changes in vertical alveolar bone height (ΔH), followed by core biopsy for histopathological evaluation of bone quality.
| Study group | Role | What they receive |
|---|---|---|
| melatonin group | Experimental | Not described Receives: Drug: Melatonin group |
| placebo group | Active comparator | Not described Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the dimensional change in vertical alveolar bone height
radiographically by cone beam C.T
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Cairo 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Safwat Moustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921355
- Sponsor's protocol ID
- 91941999
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Melatonin Gel Versus Placebo Gel Application on Bone Regeneration in Mandibular Posterior Teeth Extraction Sockets With Radiographic and Histopathological Evaluation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07921355
- Acronym / sponsor ID
- 91941999
- Conditions
- Bone Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 6 Nov 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 study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. It will include patients aged 18-30 years presenting with non-restorable mandibular molars indicated for extraction and delayed implant placement.
Eligible patients will be randomly allocated into two equal groups:
- Group I (Intervention group): Extraction sockets will be filled with locally applied melatonin gel.
- Group II (Control group): Extraction sockets will be filled with placebo gel. All patients will undergo atraumatic tooth extraction under local anesthesia, followed by socket curettage, saline irrigation, application of the allocated gel, collagen membrane coverage, and primary wound closure.
Postoperative care will include standardized medications and oral hygiene instructions. Patients will be followed up clinically and radiographically. CBCT will be used to assess the primary outcome, which is the dimensional change in vertical alveolar bone height (ΔH). At 12 weeks, core biopsy specimens will be obtained for histopathological assessment of bone quality, including newly formed bone, bone maturation, trabecular architecture, and osteoblastic activity.
Sample size: The total sample size will be determined based on the primary outcome (ΔH), using an appropriate statistical power calculation, with equal allocation between the two groups. The final number of participants will be specified according to the statistician's sample size calculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin group | Experimental | Drug: Melatonin group |
| placebo group | Active comparator | Drug: Placebo group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18-30 years
- Presence of non-restorable mandibular molars indicated for extraction
- Patients with good general health
- Adequate oral hygiene
- Patients willing to undergo implant placement after 4 months
Key exclusion criteria (5 listed)
- Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis)
- Patients receiving medications affecting bone metabolism (e.g., corticosteroids, bisphosphonates)
- Heavy smokers
- Presence of acute infection or pathological lesions at the extraction site
- Pregnant or lactating females
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 |
|---|---|---|
| Melatonin groupEligible patients will undergo atraumatic extraction of non-restorable mandibular molars under local anesthesia, followed by socket curettage and irrigation with sterile 0.9% saline. The extraction socket will be filled with locally applied melatonin gel. A collagen membrane will then be adapted to cover the socket, followed by primary wound closure using interrupted sutures. All participants will receive standardized postoperative medications and oral hygiene instructions. Clinical follow-up will be conducted at 3 days and 1 week postoperatively. At 12 weeks, CBCT examination will be performed to assess changes in vertical alveolar bone height (ΔH), followed by core biopsy for histopathological evaluation of bone qualit | Drug | melatonin group |
| Placebo groupEligible patients will undergo atraumatic extraction of non-restorable mandibular molars under local anesthesia, followed by socket curettage and irrigation with sterile 0.9% saline. The extraction socket will be filled with locally applied placebo gel. A collagen membrane will then be adapted to cover the socket, followed by primary wound closure using interrupted sutures. All participants will receive standardized postoperative medications and oral hygiene instructions. Clinical follow-up will be conducted at 3 days and 1 week postoperatively. At 12 weeks, CBCT examination will be performed to assess changes in vertical alveolar bone height (ΔH), followed by core biopsy for histopathological evaluation of bone quality. | Drug | placebo group |
Primary outcome
the dimensional change in vertical alveolar bone height
Time frame: 12 weeks
radiographically by cone beam C.T
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 6 Nov 2026.
Related trials for Bone Loss
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin group in people with Bone Loss, run by Cairo University.
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 5 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the dimensional change in vertical alveolar bone height (time frame: 12 weeks). 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 6 Nov 2026.