Maxillary Sinus Augmentation by Xenograft Mixed With Melatonin

rehab soliman16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bone Healing

Interventions

Open sinus augmentation with melatonin gel mixed with xenograftDIETARY_SUPPLEMENT

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

Open sinus augmentation with xenograftPROCEDURE

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

Eligibility

Sex: ALLMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Suez Canal University

Ismailia, Egypt

Outcomes

Primary Outcomes

Alveolar Bone Height

Alveolar Bone height was measured using cone beam computed tomography (CBCT).

Time frame: 8 months

Secondary Outcomes

Histological Analysis of Newly Formed Bone

The quality of the newly formed bone was evaluated using two histological stains: Hematoxylin and Eosin, and Masson's Trichrome.

Time frame: 8 months

Data from ClinicalTrials.gov

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