Effect of Local Application of 1% Metformin Gel on Implant Stability and Peri-implant Bone Density: A Randomized Controlled Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Baghdad

About this trial

This randomized controlled clinical study aims to evaluate the effect of local application of 1% metformin gel on implant stability and peri-implant bone density. Patients requiring dental implants will be randomly allocated into two groups: a control group and a test group receiving metformin gel. Implant stability will be assessed using resonance frequency analysis, and bone density will be evaluated using CBCT imaging. The outcomes will be compared over a follow-up period to determine the effectiveness of metformin in enhancing osseointegration

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Patients age at least 18 years old. 2) Patient with partial edentulous teeth bounded areas that need dental implant for teeth replacement.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin gel, 1%

    Drug

    A 1% metformin gel is locally applied directly into the implant osteotomy site immediately prior to implant placement. The gel is confined to the surgical site and is not systemically administered. This protocol is designed to evaluate the localized effect of metformin on implant stability and peri-implant bone density during the healing period.

  • Standard Implant Placement

    Other intervention

    Implant placement performed following the standard surgical protocol without any local pharmacological application in the osteotomy site.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: arm 1 Study group AExperimental treatment 1 intervention
Group B: arm 2 Control group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peri implant bone density

Peri-implant bone density will be evaluated using Cone Beam Computed Tomography (CBCT).

Time frame
baseline ( immediately after implant placement ) and three months postoperatively.

Secondary outcomes

1

implant stability

Implant stability will be assessed using resonance frequency analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values. Measurements will be taken at baseline, immediately after implant placement ,6 weeks, and 3 months postoperatively.

Time frame
immediately after implant placement,6 weeks, and 3 months postoperatively.

Other outcomes

Sponsors and contacts

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