Maxillary Sinus Augmentation by Xenograft Mixed With Melatonin

NCT06736821 | Completed

• 1 other identifier: 710/2023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Healing

Keywords

sinus lifting; maxillary sinus augmentation; melatonin gel

Outcome Measures

Primary Outcomes (1)

• Alveolar Bone Height

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

  8 months

Secondary Outcomes (1)

• Histological Analysis of Newly Formed Bone

  8 months

Study Arms (2)

group a: xenograft mixed with melatonin

EXPERIMENTAL

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

Dietary Supplement: Open sinus augmentation with melatonin gel mixed with xenograft

group b: xenograft

ACTIVE COMPARATOR

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

Procedure: Open sinus augmentation with xenograft

Interventions

Open sinus augmentation with melatonin gel mixed with xenograft 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

Also known as: Primary intervention

group a: xenograft mixed with melatonin

Open sinus augmentation with xenograft 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

Also known as: Secondary Intervention

group b: xenograft

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male/female patients above the age of 25.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• rehab soliman: lead

Study Sites (1)

Suez Canal University

Ismailia, 41522, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• rehab soliman

  Misr International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of oral and maxillofacial department

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 17, 2024
• Study Start: January 9, 2024
• Primary Completion: July 23, 2024
• Study Completion: August 27, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)