NCT07031778 Topic Simvastatin for Bone Regeneration
| NCT ID | NCT07031778 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Universidad de Granada |
| Condition | Dimensional Changes |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2025-01-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2025-01-07 with a primary completion date of 2025-01-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07031778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Dimensional Changes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07031778 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07031778 currently recruiting?
Yes, NCT07031778 is actively recruiting participants. Contact the research team at fjmanza@ugr.es for enrollment information.
Where is the NCT07031778 trial being conducted?
This trial is being conducted at Granada, Spain.
Who is sponsoring the NCT07031778 clinical trial?
NCT07031778 is sponsored by Universidad de Granada. The trial plans to enroll 90 participants.