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

NCT07469254 | Completed

• 1 other identifier: AUAREC20220110-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metformin Gel; Bone Graft; Immediate Dental Implants

Outcome Measures

Primary Outcomes (1)

• Assessment of Implant primary stability

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

  12 months after implant placement

Secondary Outcomes (6)

• Soft tissue change of modified Plaque Iindex

  12 months after implant placement

• Soft tissue change of modified sulcus bleeding index

  12 months after implant placement

• Soft tissue change of peri-implant probing depth

  12 months after implant placement

• Radiographic Evaluation to horizontal jumping gap

  12 months after implant insertion

• Radiographic Evaluation to buccal bone thickness

  12 months after implant insertion

Study Arms (2)

Group I

EXPERIMENTAL

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

Other: Metformin gel-xenograft

Group II

EXPERIMENTAL

Patients received immediate implant combined with xenograft alone.

Other: Xenograft

Interventions

Metformin gel-xenograft OTHER

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

Group I

Xenograft OTHER

Patients received immediate implant combined with xenograft alone.

Group II

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University (Assiut)

Asyut, 71524, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radiology, Faculty of Dental Medicine

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 13, 2026
• Study Start: November 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)