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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.
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.
Age
25 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Suez Canal University
Ismailia, Egypt
Start Date
January 9, 2024
Primary Completion Date
July 23, 2024
Completion Date
August 27, 2024
Last Updated
August 12, 2025
16
ACTUAL participants
Open sinus augmentation with melatonin gel mixed with xenograft
DIETARY_SUPPLEMENT
Open sinus augmentation with xenograft
PROCEDURE
Lead Sponsor
rehab soliman
NCT07190950
NCT06231134
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