Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Edentulous; Alveolar Process, Atrophy

Intervention / Treatment
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* Other: Melatonin and hyaluronic acid and sinus membrane elevation
* Procedure: sinus membrane elevation without any materials


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |