1% Metformin Gel-coated Implants and Osteointegration and Crestal Marginal Bone Loss

Study Overview
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Brief Summary
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Achieving and maintaining a long term osseointegrated dental implant is a golden goal of success in field of dentistry. Osteointegration depends on surface treatment of dental implants. various techniques of implant coating have been introduced to enhance and accelerate osteointegration. The purpose of present study is to clinically and radiographically evaluate the osseointegration around hydrophilic dental implants coated with 1% Metformin gel Materials and Methods: We executed a randomized controlled clinical trial. The sample will include patients demanding dental implant treatment. Patients will be randomly allocated into the two groups of the study. The group A will be treated with 1% concentrated metformin gel coated hydrophilic dental implant. Group B will be treated with uncoated hydrophilic dental implant. The primary outcome variable will be implant osteointegration and crestal marginal bone loss around implants. It will be measured at time of implant placement and reevaluated after 4, 6-months with periapical x-ray and 3-dimensional imaging.

Official Title
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Evaluation the Effect of Topically Coated Dental Implants With 1% Metformin Gel on Osteointegration and Crestal Marginal Bone Loss (a Randomized Controlled Clinical Trial)

Conditions
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Osteointegration

Intervention / Treatment
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* Other: Metformin gel coated implants
* Other: uncoated hydrophilic dental implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general periodontal health and maintenance. Adequate amount of bone volume at implant site, allowing to perform the dental implant surgery procedure without bone grafting techniques Exclusion criteria Heavy smokers who smoke more than ten cigarettes per day Diabetic patients who have received metformin as antidiabetic drug local or systemic conditions that will interfere with routine implant placement (uncontrolled diabetes mellitus or human immune deficiency virus infections, resonance therapy), bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease Patients who had subjected to intravenous and/or oral bisphosphonate therapy.

Ages Eligible for Study
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Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br> | Other: Metformin gel coated implants<br>* Patients will be treated with 1% concentrated metformin gel coated hydrophilic dental implant.<br>|
| Active Comparator: Control group<br> | Other: uncoated hydrophilic dental implants<br>* Patients treated by uncoated implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in implant stability | stability will be assessed by using ostell device | Baseline and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in marginal bone loss | To evaluate the amount of bone loss around osseointegrated implants all patient will be subjected to periapical x-ray. | Baseline and 4 months |