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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06031168

Enrollment

Registered

2023-09-11

Start date

2023-09-04

Completion date

2023-11-30

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteointegration

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.

Interventions

OTHERMetformin gel coated implants

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

OTHERuncoated hydrophilic dental implants

Patients treated by uncoated implants

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in implant stability	Baseline and 4 months	stability will be assessed by using ostell device

Secondary

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

Primary ContactMohamed Adel, BDS

adelo.free81@gmail.com01142212300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026