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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open sinus augmentation with melatonin gel mixed with xenograft | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar Bone Height | Alveolar Bone height was measured using cone beam computed tomography (CBCT). | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| rehab soliman | Misr International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University | Ismailia | 41522 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41987188 | Derived | 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. |
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| ID | Term |
|---|---|
| D014183 | Transplantation, Heterologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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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.
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| Open sinus augmentation with xenograft | Procedure | 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 |
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