Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation

Not Applicable

Completed

• Conditions: Edentulous; Alveolar Process, Atrophy
• Interventions: Procedure: sinus membrane elevation without any materials; Other: Melatonin and hyaluronic acid and sinus membrane elevation

• Registration Number: NCT04625179
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

melatonin proved an ability to repair bone defects and enhance osseointegration of dental implants. Also, hyaluronic acid has osteopromoting properties.

the effect of melatonin and hyaluronic acid on the newly formed bone in maxillary sinus augmentation was evaluated

Detailed Description

16 participants with missing maxillary posterior teeth and residual alveolar ridge of at least 5 mm will be equally and randomly divided into two groups.

The study group will receive melatonin and hyaluronic acid after sinus membrane elevation and simultaneous implant placement while the control group will not receive any materials after sinus membrane elevation and simultaneous implant placement.

Study Timeline

• Study Start: 2019-12-03
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-12
• Status Verified: 2020-12
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Age range will be between (30 - 50) years old.
• Patients with missed one or more of posterior teeth with minimum residual bone height 5 mm
• Adequate inter-occlusal space of at least 8 mm

Exclusion Criteria

• Maxillary sinus diseases.
• Previous sinus surgery like the Caldwell-Luc operation.
• History of chemotherapy or radiotherapy to maxilla.
• Presence of Underwood's septa/severe sinus floor convolutions.
• Systemic disease affecting bone metabolism.
• Uncontrolled diabetes mellitus.
• Heavy smokers.
• Para functional habits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sinus membrane elevation without any materials	sinus membrane elevation without any materials	no materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants.
Melatonin and hyaluronic acid and sinus membrane elevation	Melatonin and hyaluronic acid and sinus membrane elevation	melatonin and hyaluronic acid will be placed after maxillary sinus membrane elevation and simultaneous dental implants placement

Primary Outcome Measures

Name	Time	Method
change Implant stability	at baseline and 6 months	The result is presented as an ISQ value of 1-100. The acceptable stability range lies between 55-85 ISQ. The higher the ISQ, the more stable the implant
change in bone density	at baseline, 1 month and 6 months	radiographical evaluation using CBCT
change in vertical bone height	at baseline, 1 month and 6 months	radiographical evaluation using CBCT
change in marginal bone level	at baseline, 1 month and 6 months	radiographical evaluation using CBCT

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	after 1 week	based on a 4-point verbal descriptive scale as following: no pain, mild (recognizable but not discomforting pain that required no analgesics), moderate (discomforting but bearable pain and analgesics if used were effective in relieving pain) and severe (difficult to bear and analgesics were effective in relieving pain).
Postoperative swelling	after 1 week	none (no inflammation), mild (intraoral swelling confined to the surgical field), moderate (extraoral swelling in the surgical zone) and severe (extraoral swelling spreading beyond the surgical zone).

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt