Topic Simvastatin for Bone Regeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to evaluate the efficacy of topical application of simvastatin in bone regeneration in the maxillae, in the reduction of dimensional bone changes, using mandibular third molar surgery as a model and assessing bone healing at 12 weeks. We will also compare the two forms of intralveolar topical administration currently used to assess which is the best form of administration. The main questions it aims to answer are:

* Can the topical application of simvastatin, used as a preservation material, improve the variations with respect to bone dimensions and density that occur after tooth extraction.
* Can topical application of SM improve soft tissue healing.
* Does the topical application of SM produce changes with respect to postoperative variables of pain, inflammation or trismus.
* What is the best vehicle for topical SM administration?

For this purpose, the investigators will randomly place 4 topical treatment options in the postextraction alveoli:

* SM in gel form
* collagen sponge impregnated with saline solution containing 10 mg of SM
* collagen sponge with placebo gel. All patients will undergo postoperative CBCT, which will be repeated at 12 weeks.

In addition, inflammation, trismus and pain variables will be measured preoperatively, at 24 hours, 3 and 7 days.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth

NCT01085149

Hypercholesterolemia

UNKNOWN NA

Statin and Bone Health

NCT05613400

Diabetes Mellitus, Type 2

UNKNOWN PHASE4

Efficacy and Safety of Minodronate in Patients With Low Back Pain

NCT05645289

Postmenopausal Osteoporosis

UNKNOWN PHASE4

Simvastatin to Prevent SCI-Induced Bone Loss

NCT02946424

Spinal Cord Injuries Osteoporosis

UNKNOWN PHASE2

A Phase III Clinical Study of Minodronate Tablets in Postmenopausal Women With Osteoporosis

NCT05305183

Osteoporosis

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study design is a double-blind randomized clinical trial (RCT). The study population consisted of patients referred to the Master's Degree in Oral Surgery and Implantology of the Faculty of Dentistry of the UGR (Granada) with an indication for surgical extraction of mandibular third molars.

A sample of 90 third molars will be used to establish a confidence level of 95% and a power of 90%. The sample will be divided into 3 groups of 30 each. Group I: 30 mandibular third molars in which gel with 1.2% simvastatin is used for healing. Group II: 30 mandibular third molars in which a collagen sponge impregnated with saline solution containing 10 mg of the active ingredient simvastatin is used for healing. Group III: 30 mandibular third molars in which a collagen sponge impregnated in gel without SM is used for healing.

SURGICAL PROCEDURE:

Extraction will be performed only of included mandibular third molars. For this purpose we will anesthetize the lower dental nerve, lingual nerve and buccal nerve using 4% articaine with epinephrine by means of the truncular technique.

The intervention will be performed by flap lifting, ostectomy with handpiece and round bur, or odontosection with turbine whenever the case requires it. The socket will be curetted and washed with physiological saline solution to ensure that no surgical debris remains. After this, we will proceed to place in the socket the combination of material chosen by randomization (simvastatin gel, gel without simvastatin, collagen sponge with simvastatin or only collagen sponge). Once the filling material has been placed, we will proceed to the primary closure of the wound with 3.0 silk. We will place a gauze with 0.20% chlorhexidine gel at the end of the extraction, for the patient to keep it for 30 minutes. We will indicate to the patient the appropriate postoperative care and we will prescribe 0.12% chlorhexidine mouthwash for rinsing after brushing. One week later, the patient will be seen to remove the suture.

Postoperative medication:

* Antibiotic treatment: amoxicillin 750 mg 1 every 8 hours, for 7 days. In case of allergy to penicillin, the drug of choice will be clindamycin 300 mg 1 every 8 hours.
* Analgesic and anti-inflammatory treatment: ibuprofen 400 mg 1 every 8 hours for two days, from the third day on demand. Rescue paracetamol 1 g.

VARIABLES TO BE STUDIED

Primary Variables:

The primary variable to be studied will be the dimensional changes

Secondary variables:

The secondary variables to be studied will be bone density measured in Hounsfield units , soft tissue healing, pain and analgesia, inflammation and trismus.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dimensional Changes Bone Density

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

drug intervention: Gel SM

30 lower third molars in whose alveolus post-extraction we will place simvastatin gel at 1.2%.

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Simvastatin gel with 1.2% simvastatin

Drug intervention: Sm + collagen sponge

30 lower third molars in whose alveolus post-extraction we will place a collagen sponge impregnated with saline solution containing 10 mg of simvastatin.

Group Type ACTIVE_COMPARATOR

Simvastatin 10 mg

Intervention Type DRUG

sponge of collagen impregned in saline solution with 10 mg of simvastatin

Control

30 lower third molars in whose alveolus post-extraction we will place a collagen sponge impregnated with gel without simvastatin

Group Type PLACEBO_COMPARATOR

Simvastatin Placebo

Intervention Type DRUG

Collagen sponge impregned in simvastatin placebo gel without simvastatin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simvastatin

Simvastatin gel with 1.2% simvastatin

Intervention Type DRUG

Simvastatin 10 mg

sponge of collagen impregned in saline solution with 10 mg of simvastatin

Intervention Type DRUG

Simvastatin Placebo

Collagen sponge impregned in simvastatin placebo gel without simvastatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Anesthetic risk ASA I-II.
* Patients with the adjacent tooth in the mouth (37 or 47).
* Third molars with fully developed roots.
* Mandibular third molars included or semi-included.
* With indication for extraction.
* Signed informed consent.

Exclusion Criteria

* Pregnant or lactating women.
* Chronic smokers.
* Patients with decompensated metabolic disease.
* Patients with motor difficulties that prevent or hinder hygiene.
* Patients who are using statins to treat hypercholesterolemia.
* Patients under treatment with drugs that could affect the osseointegration process such as chemotherapy drugs, bisphosphonates, corticosteroids or immunosuppressants.
* Patients with metabolic bone diseases or who have undergone radiotherapy in the last five years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes