Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation

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

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

Study Overview

• Status: Completed
• Conditions: Edentulous; Alveolar Process, Atrophy
• Intervention / Treatment: Other: Melatonin and hyaluronic acid and sinus membrane elevation; Procedure: sinus membrane elevation without any materials

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Melatonin and hyaluronic acid and sinus membrane elevation; 3 mg melatonin powder mixed with 0.2% hyaluronic acid gel will be placed to fill the sinus space and around the implant apex.
Active Comparator: sinus membrane elevation without any materials; no materials will be placed after maxillary sinus membrane elevation and simultaneous dental implants.	Procedure: sinus membrane elevation without any materials; No materials will be placed at the sinus space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change Implant stability	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	at baseline and 6 months
change in bone density	radiographical evaluation using CBCT	at baseline, 1 month and 6 months
change in vertical bone height	radiographical evaluation using CBCT	at baseline, 1 month and 6 months
change in marginal bone level	radiographical evaluation using CBCT	at baseline, 1 month and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	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).	after 1 week
Postoperative swelling	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).	after 1 week

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): December 7, 2020

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Antioxidants; Viscosupplements; Melatonin; Hyaluronic Acid
• Other Study ID Numbers: maxillary sinus augmentation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No