NCT07031778

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

Same day

First QC Date

May 23, 2025

Last Update Submit

June 12, 2025

Conditions

Dimensional ChangesBone Density

Keywords

simvastatinbone densitydimensional changescbct scan

Outcome Measures

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).

    From the time of extraction to when bone regeneration is supposed to be completed 12 weeks later.

Secondary Outcomes (1)

  • Bone density

    Postextraction to the end of bone regeneration at 12 week latter

Study Arms (3)

drug intervention: Gel SM

EXPERIMENTAL

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

Drug: Simvastatin

Drug intervention: Sm + collagen sponge

ACTIVE COMPARATOR

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

Drug: Simvastatin 10 mg

Control

PLACEBO COMPARATOR

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

Drug: Simvastatin Placebo

Interventions

SimvastatinDRUG

Simvastatin gel with 1.2% simvastatin

drug intervention: Gel SM
Simvastatin 10 mgDRUG

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

Drug intervention: Sm + collagen sponge
Simvastatin PlaceboDRUG

Collagen sponge impregned in simvastatin placebo gel without simvastatin

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UGranada

Granada, Granada, 18071, Spain

RECRUITING

Related Publications (4)

  • Degala S, Bathija NA. Evaluation of the Efficacy of Simvastatin in Bone Regeneration after Surgical Removal of Bilaterally Impacted Third Molars-A Split-Mouth Randomized Clinical Trial. J Oral Maxillofac Surg. 2018 Sep;76(9):1847-1858. doi: 10.1016/j.joms.2018.04.035. Epub 2018 May 31.

    PMID: 29859160BACKGROUND

  • Cruz R, Moraschini V, Calasans-Maia MD, de Almeida DCF, Sartoretto SC, Granjeiro JM. Clinical efficacy of simvastatin gel combined with polypropylene membrane on the healing of extraction sockets: A triple-blind, randomized clinical trial. Clin Oral Implants Res. 2021 Jun;32(6):711-720. doi: 10.1111/clr.13740. Epub 2021 Mar 27.

    PMID: 33715258BACKGROUND

  • Deepanjali M, Prasad TS, Manodh P. Efficacy of simvastatin in bone regeneration after surgical removal of mandibular third molars. Oral Maxillofac Surg. 2023 Sep;27(3):427-432. doi: 10.1007/s10006-022-01081-y. Epub 2022 Jun 1.

    PMID: 35648294BACKGROUND

  • Diniz JA, Barbirato DDS, do Nascimento EHL, Pontual ADA, Dourado ACAG, Laureano Filho JR. Tomographic evaluation of the effect of simvastatin topical use on alveolar bone microarchitecture, pain and swelling after mandibular third molar extraction: a randomized controlled trial. Clin Oral Investig. 2022 Apr;26(4):3533-3545. doi: 10.1007/s00784-021-04322-8. Epub 2022 Jan 22.

    PMID: 35064813BACKGROUND

MeSH Terms

Interventions

Simvastatin

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Central Study Contacts

Manzano-Moreno FJ Francisco Javier Manzano-Moreno

CONTACT

+34651606228fjmanza@ugr.es

Lopez-Andrade E Elena López-Andrade

CONTACT

+34656821779elenitandrade@correo.ugr.es

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, DDS

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 22, 2025

Study Start

January 7, 2025

Primary Completion

January 7, 2025

Study Completion

December 31, 2025

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)