NCT06736821

Maxillary Sinus Augmentation by Xenograft Mixed With Melatonin

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: rehab soliman · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Bone Healing

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Open sinus augmentation with melatonin gel mixed 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
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 xenograft as an augmentation material xenograft is used instead of autogenous bone graft to avoid the morbidity of the donor side

Timeline

• Start date: 2024-01-09
• Primary completion: 2024-07-23
• Completion: 2024-08-27
• First posted: 2024-12-17
• Last updated: 2025-08-12

Locations

1 site across 1 country: Egypt