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Completed

NCT Number: NCT07469254

Adding 1% Metformin Gel to Bone Graft in Association With Immediate Dental Implants

This study aimed to investigate whether combining xenografts with Metformin Gel gel enhances bone regeneration and improves implant outcomes.

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Key information

Conditions

Metformin Gel Bone Graft Immediate Dental Implants

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University (Assiut)

Asyut, 71524, Egypt

About this study

The placement of a dental implant in an extraction socket at the time of extraction or explanation is known as immediate implant placement whereas delayed placement of implant signifies the implant placement in edentulous areas where healing has completed with new bone formation after the loss of tooth/teeth.

The xenograft is derived from other organisms, mainly bovine. It provides long-term volume stability. Porous natural hydroxyapatite can be obtained from animal bones.

Metformin HCl (1, 1-dimethylbiguanide HCl) (MF), is one of the most commonly used oral anti-hyperglycemic agents for the treatment of type 2 diabetes mellitus. The use of MF may reduce the association between diabetes and fractures in patients with both type 1 and type 2DM.MF increase type I collagen production in osteoblast-like cell lines and stimulated alkaline phosphate activity in osteoblasts.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 40 years.
  • Both sexes.
  • Adult individual with non-restorable tooth in esthetic and premolars area and seeking for immediate implant placement.
  • Systemically healthy patients were selected for implant surgery according to the criteria of Cornell medical index and its modifications.
  • The recipient site of the implant should be free from any pathological conditions.
  • Sufficient vertical bone height to safely place at least 12 mm long dental implant.

Exclusion criteria

  • Smokers.
  • Pregnant or lactating female patients.
  • Patients with parafunctional habits such as bruxism and clenching.
  • Presence of acute infection around the failing tooth.
  • Perforation and/or loss of the labial bony plate following tooth removal and/or implant osteotomy.
  • Inability to attain primary implant stability following immediate implant placement.

Treatment and study plan

Metformin gel-xenograft

Other

Patients received immediate implant combined with a mixture of 1%metformin gel and xenograft.

Xenograft

Other

Patients received immediate implant combined with xenograft alone.

Primary outcomes

  1. Assessment of Implant primary stability

    Time frame: 12 months after implant placement

    Implant primary stability was assessed using Resonance Frequency Analysis at baseline and at 3, 6, and 12 months after implant placement.

Secondary outcomes

  1. Soft tissue change of modified Plaque Iindex

    Time frame: 12 months after implant placement

    Soft tissue change of modified Plaque Iindex (mPI) was done at baseline and 3, 6 and 12 months after implant placement

  2. Soft tissue change of modified sulcus bleeding index

    Time frame: 12 months after implant placement

    Soft tissue change of modified sulcus bleeding index was done at baseline and 3, 6 and 12 months after implant placement

  3. Soft tissue change of peri-implant probing depth

    Time frame: 12 months after implant placement

    Soft tissue change of peri-implant probing depth (PPD) was done at baseline and 3, 6 and 12 months after implant placement

  4. Radiographic Evaluation to horizontal jumping gap

    Time frame: 12 months after implant insertion

    Radiographic Evaluation to horizontal jumping gap using CBCT was done at baseline and 6 and 12 months after implant insertion

  5. Radiographic Evaluation to buccal bone thickness

    Time frame: 12 months after implant insertion

    Radiographic Evaluation to buccal bone thickness using CBCT and vertical marginal bone level and bone density were done at baseline and 6 and 12 months after implant insertion

  6. Biochemical assessment of peri-implant crevecular fluid level

    Time frame: 3 months after implant placement

    Biochemical assessment of peri-implant crevecular fluid level of osteopontin by ELISA was done at basline,1week; and 3 months after implant placement.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

The Impact of Adding 1% Metformin Gel to Bone Graft in Association With Immediate Dental Implants

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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