Effect of Locally Applied Simvastatin Gel on Dental Implant Stability and Marginal Bone Level

NCT ID: NCT07194447

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2025-07-06

Brief Summary

stability and marginal bone level. Forty-two patients received dental implants and were randomly assigned to two groups. In the test group, 1.2% simvastatin in 4% methylcellulose gel was applied around the implant, while in the control group, methylcellulose gel alone was used. Implant stability was measured using resonance frequency analysis at baseline, 8 weeks, and 16 weeks. Marginal bone level was assessed by cone-beam computed tomography (CBCT) at baseline and 16 weeks. The aim of the study was to investigate whether local application of simvastatin enhances osseointegration and reduces marginal bone loss compared to the control treatment.

Detailed Description

ental implant stability is a key factor for the long-term success of implant therapy. Stability depends initially on primary mechanical fixation and later on secondary biological osseointegration. Various pharmacological agents have been suggested to promote bone formation around implants, including statins. Statins, primarily used as lipid-lowering agents, also demonstrate pleiotropic effects, such as stimulating bone morphogenetic protein-2 (BMP-2) expression and enhancing osteoblastic differentiation.

This randomized, double-blind, controlled clinical trial was designed to evaluate the effect of locally applied simvastatin gel on implant stability and marginal bone level. A total of 42 patients requiring single dental implants were enrolled. Participants were randomly allocated into two groups:

Simvastatin group (test): Implants placed with local application of 1.2% simvastatin in 4% methylcellulose gel.

Control group: Implants placed with local application of 4% methylcellulose gel only.

Implant stability quotient (ISQ) values were recorded at the time of implant placement (baseline), at 8 weeks, and at 16 weeks using resonance frequency analysis (RFA). Cone-beam computed tomography (CBCT) scans were performed immediately after implant placement and at 16 weeks to measure marginal bone level changes at buccal, mesial, and distal aspects.

The primary outcome measure was implant stability, while the secondary outcome measure was marginal bone level change. The study aimed to test the hypothesis that local simvastatin application would enhance peri-implant bone healing, increase stability, and reduce marginal bone loss compared to the control group.

Ethical approval was obtained from the Research Ethics Committee, College of Dentistry, University of Baghdad, and all participants provided written informed consent before enrollment.

Conditions

Dental Implants , Osseointegration , Marginal Bone Loss , Implant Stability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Simvastatin Gel Group

Participants received dental implants with a single local application of 1.2% simvastatin in 4% methylcellulose gel applied around the implant site immediately after implant placement and prior to flap closure.

Group Type: ACTIVE_COMPARATOR

Simvastatin Gel

Intervention Type: DRUG

A single local application of 1.2% simvastatin incorporated into 4% methylcellulose gel, placed around the implant site immediately after implant placement and before flap closure.

Control Gel Group

articipants received dental implants with a single local application of 4% methylcellulose gel without simvastatin, applied around the implant site immediately after implant placement and prior to flap closure.

Group Type: PLACEBO_COMPARATOR

Methylcellulose Gel

Intervention Type: DRUG

A single local application of 4% methylcellulose gel without simvastatin, placed around the implant site immediately after implant placement and before flap closure.

Interventions

Simvastatin Gel

A single local application of 1.2% simvastatin incorporated into 4% methylcellulose gel, placed around the implant site immediately after implant placement and before flap closure.

Intervention Type: DRUG

Methylcellulose Gel

A single local application of 4% methylcellulose gel without simvastatin, placed around the implant site immediately after implant placement and before flap closure.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy patients ≥ 18 years of either gender.

2. Having missing teeth in maxillary jaw maxillary jaw( premolar and molar area) at least 6 months after teeth extraction.

3. Patients who had alveolar ridges of sufficient vertical and horizontal dimensions and were considered surgically straight forward cases according to SAC classification

Exclusion Criteria

1. Patients with signs of acute or chronic infection in the implant zone

2. Patients with signs of parafunctional habits

3. Patients with history of systemic diseases or recent radiotherapy to the head and neck or chemotherapy.

4. Patients who had history or were currently under treatment with oral or intravenous bisphosphonate or statins other drugs that may alter bone metabolism

5. Patients who are heavy smoker or presented with severe periodontitis.

6. Pregnant patients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maha Zuhair

OTHER

Sponsor Role: lead

Responsible Party

Maha Zuhair

Maha Zuhair Ahmed Al-Chalabi

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

College of Dentistry, University of Baghdad

Baghdad, Baghdad Governorate, Iraq

Countries

Iraq

Related Links

https://codental.uobaghdad.edu.iq/

Related Info

Other Identifiers

UBaghdad-ImplantSIMV-2025

Identifier Type: -

Identifier Source: org_study_id