Topic Simvastatin for Bone Regeneration
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversidad de Granada
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Pregnant or lactating women.
Chronic smokers.
Patients with decompensated metabolic disease.
Patients with motor difficulties that prevent or hinder hygiene.
Trial design
Design model
Parallel
Treatments tested in this trial
Simvastatin
DrugSimvastatin gel with 1.2% simvastatin
Simvastatin 10 mg
Drugsponge of collagen impregned in saline solution with 10 mg of simvastatin
Simvastatin Placebo
DrugCollagen sponge impregned in simvastatin placebo gel without simvastatin
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: drug intervention: Gel SMExperimental treatment 1 intervention
Group B: Drug intervention: Sm + collagen spongeActive comparator 1 intervention
Group C: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dimensional changes
The primary variable to be studied will be the bone dimensional changes that occur after tooth extraction, both horizontally and vertically. These will be assessed by means of CBCT scans carried out immediately postoperatively (T0) and 12 weeks later (T1).
Time frame
From the time of extraction to when bone regeneration is supposed to be completed 12 weeks later.Secondary outcomes
1
Bone density
Bone density measured in Hounsfield units on CBCT post-extraction and at 12 weeks
Time frame
Postextraction to the end of bone regeneration at 12 week latterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov