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

NCT07194447 | Completed

• 1 other identifier: UBaghdad-ImplantSIMV-2025
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants , Osseointegration , Marginal Bone Loss , Implant Stability

Keywords

Simvastatin, Local Drug Delivery, Dental Implant Stability , Marginal Bone Level , ,

Outcome Measures

Primary Outcomes (1)

• Implant Stability Quotient (ISQ)

  Implant stability was assessed using resonance frequency analysis (Osstell device). ISQ values were recorded at baseline (implant placement), 8 weeks, and 16 weeks postoperatively.

  Baseline, 8 weeks, and 16 weeks

Secondary Outcomes (1)

• Marginal Bone Level (MBL)

  Baseline and 16 weeks

Study Arms (2)

Simvastatin Gel Group

ACTIVE COMPARATOR

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.

Drug: Simvastatin Gel

Control Gel Group

PLACEBO COMPARATOR

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.

Drug: Methylcellulose Gel

Interventions

Simvastatin Gel 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.

Simvastatin Gel Group

Methylcellulose Gel DRUG

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

Control Gel Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patients ≥ 18 years of either gender.
• Having missing teeth in maxillary jaw maxillary jaw( premolar and molar area) at least 6 months after teeth extraction.
• Patients who had alveolar ridges of sufficient vertical and horizontal dimensions and were considered surgically straight forward cases according to SAC classification

You may not qualify if:

• Patients with signs of acute or chronic infection in the implant zone
• Patients with signs of parafunctional habits
• Patients with history of systemic diseases or recent radiotherapy to the head and neck or chemotherapy.
• Patients who had history or were currently under treatment with oral or intravenous bisphosphonate or statins other drugs that may alter bone metabolism
• Patients who are heavy smoker or presented with severe periodontitis.
• Pregnant patients.

Sponsors & Collaborators

• Maha Zuhair: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, Baghdad Governorate, 10071, Iraq

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind design was implemented to ensure that participants, care providers, investigators, and outcome assessors were unaware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Maha Zuhair Ahmed Al-Chalabi

Model Details: Participants were randomly assigned in a 1:1 ratio to either the test group (simvastatin gel) or the control group (methylcellulose gel).

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 26, 2025
• Study Start: October 3, 2024
• Primary Completion: July 6, 2025
• Study Completion: July 6, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)