Clinical trial NCT06736821: Maxillary Sinus Augmentation by Xenograft Mixed With Melatonin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Healing
Keywords: sinus lifting
maxillary sinus augmentation
melatonin gel
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was included16 severely atrophied maxillary sinus, with alveolar bone height less than 4mm, that need sinus augmentation and delayed implant placement. all patients was enrolled randomly and distributed into 2 groups (via : http://www.randomizer.org) :

Group A: sinus membrane elevation was done using lateral window technique and filled with the mixture of melatonin and xenograft.

Group B: sinuses membrane was elevated and filled with with xenograft. After 6 months, bone biopsies was collected from the augmented sinuses immediately before implant instalment in the same visit.

Initial CBCT was taken preoperatively and immediate postoperatively. Final CBCT was taken 6 months before implant placement to measure Bone density and bone height and width.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Adult male/female patients above the age of 25.
2. Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).
3. Alveolar bone height less than 4 mm at the defective site.
4. Good oral hygiene.

Exclusion Criteria:

1. Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
2. Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
3. Heavy smokers.
4. Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated periodontal disease).

Primary outcomes:
measure: bone height
timeFrame: 6 months
Secondary outcomes:
measure: histological analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References: