An interventional study of Open sinus augmentation with melatonin gel mixed with xenograft and Open sinus augmentation with xenograft in Bone Healing, sponsored by rehab soliman. Completed at 1 site in Egypt. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by rehab soliman · Not applicable, Interventional, and Treatment
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.
rehab soliman is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Dietary Supplement: Open sinus augmentation with melatonin gel mixed with xenograft
in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft without any additives
Procedure: Open sinus augmentation with xenograft
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
Also known as: Primary 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
Also known as: Secondary Intervention
Alveolar Bone Height
Alveolar Bone height was measured using cone beam computed tomography (CBCT).
Time frame: 8 months
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.
Time frame: 8 months
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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