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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bone Healing
- Sponsor
- rehab soliman
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Alveolar Bone Height
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief 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.
Investigators
rehab soliman
lecturer of oral and maxillofacial department
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •Adult male/female patients above the age of
- •Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).
- •Alveolar bone height less than 4 mm at the defective site.
- •Good oral hygiene.
Exclusion Criteria
- •Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
- •Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
- •Heavy smokers.
- •Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated periodontal disease).
Outcomes
Primary Outcomes
Alveolar Bone Height
Time Frame: 8 months
Alveolar Bone height was measured using cone beam computed tomography (CBCT).
Secondary Outcomes
- Histological Analysis of Newly Formed Bone(8 months)