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

Hams Hamed Abdelrahman

Status: Not yet enrolling

Conditions: Osteointegration

Treatments: Other: Metformin gel coated implants; Other: uncoated hydrophilic dental implants

Study type: Interventional

Funder types: Other

Identifiers

NCT06031168

Implants_2023

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Test group

Experimental group

Treatment:

Other: Metformin gel coated implants

Control group

Active Comparator group

Treatment:

Other: uncoated hydrophilic dental implants