Skip to main content
OpenTrials
Completed

NCT Number: NCT06736821

Maxillary Sinus Augmentation by Xenograft Mixed With Melatonin

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, 41522, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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).

Treatment and study plan

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

Other names: Primary intervention

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

Other names: Secondary Intervention

Primary outcomes

  1. Alveolar Bone Height

    Time frame: 8 months

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

Secondary outcomes

  1. Histological Analysis of Newly Formed Bone

    Time frame: 8 months

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

Sponsors and collaborators

Lead sponsor

rehab soliman

Other

Registry information

Official study 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

Acronym: melatonin

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.