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

September 3, 2023 updated by: Hams Hamed Abdelrahman

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • Mohamed Adel, BDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 4, 2023

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

September 3, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 3, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Implants_2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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