Bone HealingmelatoninNCT06736821
Maxillary Sinus Augmentation by Xenograft Mixed With Melatonin
A study testing Open sinus augmentation with melatonin gel mixed with xenograft and Open sinus augmentation with xenograft in people with Bone Healing, run by rehab soliman at 1 site in Egypt.
Trial summary
The possibility of enhancing the bone substitute in the maxillary sinus by mixing it with the melatonin to allow proper implant placement in early stage . The aim of the study was to evaluate clinically, radiographically and histologically the effect of melatonin in enhancement of bone healing after augmentation of… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Healing
- What is being tested?
- Open sinus augmentation with melatonin gel mixed with xenograft and Open sinus augmentation with xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jan 2024to 27 Aug 2024
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male/female patients above the age of 25.
- Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).
- Alveolar bone height less than 4 mm at the defective site.
- Good oral hygiene.
Who cannot join
- Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
- Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
- Heavy smokers.
- Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated periodontal disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Radiographic and Histomorphometric Assessment of the Effect of Melatonin Gel Mixed With Xenograft in Augmentation of the Maxillary Sinus: A Randomized Controlled Clinical Trial
The possibility of enhancing the bone substitute in the maxillary sinus by mixing it with the melatonin to allow proper implant placement in early stage .
The aim of the study was to evaluate clinically, radiographically and histologically the effect of melatonin in enhancement of bone healing after augmentation of the maxillary sinus.
Read the detailed description
This study was include 16 severely atrophied maxillary sinus, with alveolar bone height less than 4mm, that need sinus augmentation and delayed implant placement, they were be equally and randomly distributed into 2 groups (via : http://www.randomizer.org) :
Group A: sinuses was received sinus membrane elevation using lateral window technique and filling the sinus with the mixture of melatonin and xenograft.
Group B: sinuses was received sinus membrane elevation using lateral window technique and filling the sinus with xenograft.
After 6 months, bone biopsies was collected from the augmented sinuses immediately before implant instalment in the same visit.
Initial cone beam computerized tomography was taken preoperatively and immediate postoperatively.
Final cone beam computerized tomography was taken 6 months before implant placement to measure Bone density and bone height and width.
After 3 months of implant placement, the installed implants was assessed clinically to exclude any infection or dehiscence and radio graphically to assess the bone loss or any radiolucent lesion around the implants and then prepared for loading.
- Conditions
- Bone Healing
- Being tested
- Open sinus augmentation with melatonin gel mixed with xenograft, Open sinus augmentation with xenograft
- Keywords
- sinus lifting, maxillary sinus augmentation, melatonin gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open sinus augmentation with melatonin gel mixed with xenograftDietary supplement
Also called Primary intervention
All Patients in this group underwent open sinus procedures to lift the sinus membrane followed by application of the melatonin gel which was mixed with xenograft as an augmentation material.
Preclinical studies proved the direct action of melatonin in enhancing the differentiation and proliferation of bone-forming osteoblasts. In addition to increasing bone mass, melatonin also facilitates new bone growth and osteointegration, making melatonin a particularly attractive molecule for use in bone implants when used alone or in combination with other growth factors
Open sinus augmentation with xenograftProcedure or surgery
Also called Secondary Intervention
All Patients in this group underwent open sinus procedures to lift the sinus membrane followed by application of the xenograft as an augmentation material xenograft is used instead of autogenous bone graft to avoid the morbidity of the donor side
| Study group | Role | What they receive |
|---|---|---|
| group a: xenograft mixed with melatonin | Experimental | in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft mixed with melatonin gel to enhance the bone healing Receives: Dietary Supplement: Open sinus augmentation with melatonin gel mixed with xenograft |
| group b: xenograft | Active comparator | in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft without any additives Receives: Procedure: Open sinus augmentation with xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar Bone Height
Alveolar Bone height was measured using cone beam computed tomography (CBCT).
Measured: 8 months
Secondary outcomes (1)
Histological Analysis of Newly Formed Bone
The quality of the newly formed bone was evaluated using two histological stains: Hematoxylin and Eosin, and Masson's Trichrome.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start9 Jan 2024
- Primary completion23 Jul 2024
- Study completion27 Aug 2024
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 Bone 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
- Parallel groups
- Model description
- This study was included16 severely atrophied maxillary sinus, with alveolar bone height less than 4mm, that need sinus augmentation and delayed implant placement. all patients was enrolled randomly and distributed into 2 groups (via : http://www.randomizer.org) : Group A: sinus membrane elevation was done using lateral window technique and filled with the mixture of melatonin and xenograft. Group B: sinuses membrane was elevated and filled with with xenograft. After 6 months, bone biopsies was collected from the augmented sinuses immediately before implant instalment in the same visit. Initial CBCT was taken preoperatively and immediate postoperatively. Final CBCT was taken 6 months before implant placement to measure Bone density and bone height and width.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- rehab soliman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, rehab soliman, Ain Shams University
- Investigators
- rehab soliman, Principal investigator, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736821
- Sponsor's protocol ID
- 710/2023
- Acronym
- melatonin
- Status last verified
- Aug 2025
- First submitted
- 8 Dec 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ElSholkamy M, Makawi DM, ElKhateeb SM, Soliman T, Soliman RA. Clinical, radiographic and histomorphometric assessment of the effects of melatonin gel mixed with a xenograft in augmentation of the maxillary sinus: a randomized controlled clinical trial. BMC Oral Health. 2026 Apr 16;26(1):732. doi: 10.1186/s12903-026-08201-0.
PubMed 41987188
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Histomorphometric Assessment of the Effect of Melatonin Gel Mixed With Xenograft in Augmentation of the Maxillary Sinus: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06736821
- Acronym / sponsor ID
- melatonin / 710/2023
- Conditions
- Bone Healing
- Keywords
- sinus lifting, maxillary sinus augmentation, melatonin gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- rehab solimanUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 17 Dec 2024 (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.
The possibility of enhancing the bone substitute in the maxillary sinus by mixing it with the melatonin to allow proper implant placement in early stage .
The aim of the study was to evaluate clinically, radiographically and histologically the effect of melatonin in enhancement of bone healing after augmentation of the maxillary sinus.
Detailed description
This study was include 16 severely atrophied maxillary sinus, with alveolar bone height less than 4mm, that need sinus augmentation and delayed implant placement, they were be equally and randomly distributed into 2 groups (via : http://www.randomizer.org) :
Group A: sinuses was received sinus membrane elevation using lateral window technique and filling the sinus with the mixture of melatonin and xenograft.
Group B: sinuses was received sinus membrane elevation using lateral window technique and filling the sinus with xenograft.
After 6 months, bone biopsies was collected from the augmented sinuses immediately before implant instalment in the same visit.
Initial cone beam computerized tomography was taken preoperatively and immediate postoperatively.
Final cone beam computerized tomography was taken 6 months before implant placement to measure Bone density and bone height and width.
After 3 months of implant placement, the installed implants was assessed clinically to exclude any infection or dehiscence and radio graphically to assess the bone loss or any radiolucent lesion around the implants and then prepared for loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was included16 severely atrophied maxillary sinus, with alveolar bone height less than 4mm, that need sinus augmentation and delayed implant placement. all patients was enrolled randomly and distributed into 2 groups (via : http://www.randomizer.org) : Group A: sinus membrane elevation was done using lateral window technique and filled with the mixture of melatonin and xenograft. Group B: sinuses membrane was elevated and filled with with xenograft. After 6 months, bone biopsies was collected from the augmented sinuses immediately before implant instalment in the same visit. Initial CBCT was taken preoperatively and immediate postoperatively. Final CBCT was taken 6 months before implant placement to measure Bone density and bone height and width.
| Arm | Type | Receives |
|---|---|---|
| group a: xenograft mixed with melatonin | Experimental | Dietary Supplement: Open sinus augmentation with melatonin gel mixed with xenograftin this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft mixed with melatonin gel to enhance the bone healing |
| group b: xenograft | Active comparator | Procedure: Open sinus augmentation with xenograftin this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft without any additives |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male/female patients above the age of 25.
- Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).
- Alveolar bone height less than 4 mm at the defective site.
- Good oral hygiene.
Key exclusion criteria (4 listed)
- Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
- Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
- Heavy smokers.
- Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated 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 |
|---|---|---|
| Open sinus augmentation with melatonin gel mixed with xenograftAlso: Primary interventionAll Patients in this group underwent open sinus procedures to lift the sinus membrane followed by application of the melatonin gel which was mixed with xenograft as an augmentation material. Preclinical studies proved the direct action of melatonin in enhancing the differentiation and proliferation of bone-forming osteoblasts. In addition to increasing bone mass, melatonin also facilitates new bone growth and osteointegration, making melatonin a particularly attractive molecule for use in bone implants when used alone or in combination with other growth factors | Dietary supplement | group a: xenograft mixed with melatonin |
| Open sinus augmentation with xenograftAlso: Secondary InterventionAll Patients in this group underwent open sinus procedures to lift the sinus membrane followed by application of the xenograft as an augmentation material xenograft is used instead of autogenous bone graft to avoid the morbidity of the donor side | Procedure or surgery | group b: xenograft |
Primary outcome
Alveolar Bone Height
Time frame: 8 months
Alveolar Bone height was measured using cone beam computed tomography (CBCT).
1 secondary outcome
Histological Analysis of Newly Formed Bone
Time frame: 8 months
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 12 Aug 2025.
- Derived from this study: PubMed 41987188ElSholkamy M, Makawi DM, ElKhateeb SM, Soliman T, Soliman RA. Clinical, radiographic and histomorphometric assessment of the effects of melatonin gel mixed with a xenograft in augmentation of the maxillary sinus: a randomized controlled clinical trial. BMC Oral Health. 2026 Apr 16;26(1):732. doi: 10.1186/s12903-026-08201-0.
- Individual participant dataSharing planned: No
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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.
rehab soliman principal investigator
Misr International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open sinus augmentation with melatonin gel mixed with xenograft and Open sinus augmentation with xenograft in people with Bone Healing, run by rehab soliman 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 4 inclusion and 4 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 12 Aug 2025. 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 Height (time frame: 8 months). 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 NCT06736821, 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 12 Aug 2025.