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

Sponsor

Hams Hamed Abdelrahman (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06031168

Collaborator

(none)

Enrollment

Location

Arms

2.9

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteointegration	Other: Metformin gel coated implants Other: uncoated hydrophilic dental implants	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 4, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Test group

Other: Metformin gel coated implants

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

Active Comparator: Control group

Other: uncoated hydrophilic dental implants

Patients treated by uncoated implants

Outcome Measures

Primary Outcome Measures

Change in implant stability [Baseline and 4 months]
stability will be assessed by using ostell device

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University

ClinicalTrials.gov Identifier:

NCT06031168

Other Study ID Numbers:

Implants_2023

First Posted:

Sep 11, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metformin

Study Results

No Results Posted as of Sep 11, 2023