Suez Canal University
Ismailia, 41522, Egypt
NCT Number: NCT06736821
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.
Looking for future studies?
Notify Me25 year and older
All sexes
Interventional
Not applicable
Ismailia, 41522, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: 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
Other names: Secondary Intervention
Time frame: 8 months
Alveolar Bone height was measured using cone beam computed tomography (CBCT).
Time frame: 8 months
The quality of the newly formed bone was evaluated using two histological stains: Hematoxylin and Eosin, and Masson's Trichrome.
rehab soliman
Other
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
Acronym: melatonin
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06766292
Bone Healing, Sinus Membrane Osteoginicity
Ismailia, Egypt
View Trial DetailsNCT06231134
Bone Healing, Dental Implant
Alexandria, Egypt
View Trial DetailsNCT06885983
Augmentation, Augmentation, Alveolar Ridge
Belgrade, Serbia
View Trial DetailsNCT07505433
Bone Healing
View Trial Details