Maxillary Sinus Augmentation by Xenograft Mixed With Melatonin

NCT ID: NCT06736821

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2024-08-27

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.

Conditions

Bone Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

group a: xenograft mixed with melatonin

in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft mixed with melatonin gel to enhance the bone healing

Group Type: EXPERIMENTAL

Open sinus augmentation with melatonin gel mixed with xenograft

Intervention Type: DIETARY_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

group b: xenograft

in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft without any additives

Group Type: ACTIVE_COMPARATOR

Open sinus augmentation with xenograft

Intervention Type: PROCEDURE

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

Interventions

Open sinus augmentation with melatonin gel mixed with xenograft

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

Intervention Type: DIETARY_SUPPLEMENT

Open sinus augmentation with xenograft

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

Intervention Type: PROCEDURE

Other Intervention Names

Primary intervention; Secondary Intervention

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).

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

rehab soliman

OTHER

Sponsor Role: lead

Responsible Party

rehab soliman

lecturer of oral and maxillofacial department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

rehab soliman

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

710/2023

Identifier Type: -

Identifier Source: org_study_id