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Clinical Trials/NCT04625179
NCT04625179
Completed
Not Applicable

Evaluation of Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation (a Randomized Controlled Clinical Trial)

Hams Hamed Abdelrahman1 site in 1 country16 target enrollmentDecember 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Edentulous; Alveolar Process, Atrophy
Sponsor
Hams Hamed Abdelrahman
Enrollment
16
Locations
1
Primary Endpoint
change Implant stability
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 3, 2019
End Date
December 7, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hams Hamed Abdelrahman
Responsible Party
Sponsor Investigator
Principal Investigator

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

change Implant stability

Time Frame: 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

Time Frame: at baseline, 1 month and 6 months

radiographical evaluation using CBCT

change in vertical bone height

Time Frame: at baseline, 1 month and 6 months

radiographical evaluation using CBCT

change in marginal bone level

Time Frame: at baseline, 1 month and 6 months

radiographical evaluation using CBCT

Secondary Outcomes

  • Postoperative pain(after 1 week)
  • Postoperative swelling(after 1 week)

Study Sites (1)

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