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

Not Applicable

Not yet recruiting

• Conditions: Osteointegration
• Interventions: Other: uncoated hydrophilic dental implants; Other: Metformin gel coated implants

• Registration Number: NCT06031168
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-03
• Study First Submitted QC: 2023-09-03
• Last Update Submitted: 2023-09-03
• Study Start: 2023-09-04
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	uncoated hydrophilic dental implants	-
Test group	Metformin gel coated implants	-

Primary Outcome Measures

Name	Time	Method
Change in implant stability	Baseline and 4 months	stability will be assessed by using ostell device

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt