Dental Implants , Osseointegration , Marginal Bone Loss , Implant StabilityNCT07194447
Effect of Locally Applied Simvastatin Gel on Dental Implant Stability and Marginal Bone Level
A study testing Simvastatin Gel and Methylcellulose Gel in people with Dental Implants , Osseointegration , Marginal Bone Loss , Implant Stability, run by Maha Zuhair at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants , Osseointegration , Marginal Bone Loss , Implant Stability
- What is being tested?
- Simvastatin Gel and Methylcellulose Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIraq
- Study dates
- 3 Oct 2024to 6 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of Dentistry, University of Baghdad
Baghdad, Baghdad Governorate, 10071
About this study
Official title: The Effect of Locally Applied Gel-Based Simvastatin on Dental Implant Stability and Marginal Bone Level : A Randomized Controlled Double-Blind Clinical Trial
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.
Read the 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.
- Being tested
- Simvastatin Gel, Methylcellulose Gel
- Keywords
- Simvastatin, Local Drug Delivery, Dental Implant Stability , Marginal Bone Level , ,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin GelDrug
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.
Methylcellulose GelDrug
A single local application of 4% methylcellulose gel without simvastatin, placed around the implant site immediately after implant placement and before flap closure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Methylcellulose Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks, and 16 weeks
Secondary outcomes (1)
Marginal Bone Level (MBL)
Marginal bone level changes were measured radiographically using cone-beam computed tomography (CBCT) at baseline and 16 weeks, recorded at buccal, mesial, and distal aspects of the implant.
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start3 Oct 2024
- Primary completion6 Jul 2025
- Study completion6 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implants , Osseointegration , Marginal Bone Loss , Implant StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the test group (simvastatin gel) or the control group (methylcellulose gel).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maha Zuhair
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maha Zuhair, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194447
- Sponsor's protocol ID
- UBaghdad-ImplantSIMV-2025
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) or additional supporting documents will be shared. Data will remain confidential and stored securely at the College of Dentistry, University of Baghdad, in accordance with institutional ethical approval
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Locally Applied Gel-Based Simvastatin on Dental Implant Stability and Marginal Bone Level : A Randomized Controlled Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07194447
- Acronym / sponsor ID
- UBaghdad-ImplantSIMV-2025
- Keywords
- Simvastatin, Local Drug Delivery, Dental Implant Stability , Marginal Bone Level , ,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Maha ZuhairUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 6 Jul 2025 (actual)
- Study completion
- 6 Jul 2025 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the test group (simvastatin gel) or the control group (methylcellulose gel).
| Arm | Type | Receives |
|---|---|---|
| Simvastatin Gel Group | Active comparator | Drug: Simvastatin GelParticipants 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. |
| Control Gel Group | Placebo comparator | Drug: Methylcellulose Gelarticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin GelA 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. | Drug | Simvastatin Gel Group |
| Methylcellulose GelA single local application of 4% methylcellulose gel without simvastatin, placed around the implant site immediately after implant placement and before flap closure. | Drug | Control Gel Group |
Primary outcome
Implant Stability Quotient (ISQ)
Time frame: Baseline, 8 weeks, and 16 weeks
Implant stability was assessed using resonance frequency analysis (Osstell device). ISQ values were recorded at baseline (implant placement), 8 weeks, and 16 weeks postoperatively.
1 secondary outcome
Marginal Bone Level (MBL)
Time frame: Baseline and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data (IPD) or additional supporting documents will be shared. Data will remain confidential and stored securely at the College of Dentistry, University of Baghdad, in accordance with institutional ethical approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simvastatin Gel and Methylcellulose Gel in people with Dental Implants , Osseointegration , Marginal Bone Loss , Implant Stability, run by Maha Zuhair at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability Quotient (ISQ) (time frame: Baseline, 8 weeks, and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.