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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-04

Study Completion Date

2023-11-30

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.

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Detailed Description

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Conditions

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Osteointegration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Test group

Group Type EXPERIMENTAL

Metformin gel coated implants

Intervention Type OTHER

Patients will be treated with 1% concentrated metformin gel coated hydrophilic dental implant.

Control group

Group Type ACTIVE_COMPARATOR

uncoated hydrophilic dental implants

Intervention Type OTHER

Patients treated by uncoated implants

Interventions

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Metformin gel coated implants

Patients will be treated with 1% concentrated metformin gel coated hydrophilic dental implant.

Intervention Type OTHER

uncoated hydrophilic dental implants

Patients treated by uncoated implants

Intervention Type OTHER

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No