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

NCT06031168 | Unknown

• 1 other identifier: Implants_2023
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteointegration

Outcome Measures

Primary Outcomes (1)

• Change in implant stability

  stability will be assessed by using ostell device

  Baseline and 4 months

Secondary Outcomes (1)

• change in marginal bone loss

  Baseline and 4 months

Study Arms (2)

Test group

EXPERIMENTAL

Other: Metformin gel coated implants

Control group

ACTIVE COMPARATOR

Other: uncoated hydrophilic dental implants

Interventions

Metformin gel coated implants OTHER

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

Test group

uncoated hydrophilic dental implants OTHER

Patients treated by uncoated implants

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Central Study Contacts

Mohamed Adel, BDS

CONTACT

01142212300; adelo.free81@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 11, 2023
• Study Start: September 4, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

EG (1)