Dimensional ChangesEarly Phase 1SMNCT07031778
Topic Simvastatin for Bone Regeneration
A Early Phase 1 study testing Simvastatin and Simvastatin 10 mg in people with Dimensional Changes and Bone Density, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dimensional Changes, Bone Density
- What is being tested?
- Simvastatin and Simvastatin 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2025to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Topical Application of Simvastatin in Bone Regeneration
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?
Read more
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.
Read the detailed description
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
- Dimensional Changes, Bone Density
- Being tested
- Simvastatin, Simvastatin 10 mg, Simvastatin Placebo
- Keywords
- simvastatin, bone density, dimensional changes, cbct scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Simvastatin gel with 1.2% simvastatin
Simvastatin 10 mgDrug
sponge of collagen impregned in saline solution with 10 mg of simvastatin
Simvastatin PlaceboDrug
Collagen sponge impregned in simvastatin placebo gel without simvastatin
| Study group | Role | What they receive |
|---|---|---|
| drug intervention: Gel SM | Experimental | 30 lower third molars in whose alveolus post-extraction we will place simvastatin gel at 1.2%. Receives: 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. Receives: 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 Receives: Drug: Simvastatin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Postextraction to the end of bone regeneration at 12 week latter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start7 Jan 2025
- Primary completion7 Jan 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dimensional ChangesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier Manzano-Moreno, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031778
- Sponsor's protocol ID
- 3904/CEIH/2023
- Other IDs
- 3904/CEIH/2023
- Acronym
- SM
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29859160Cruz 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.
PubMed 33715258Deepanjali 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.
PubMed 35648294Diniz 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.
PubMed 35064813
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Application of Simvastatin in Bone Regeneration
- ClinicalTrials.gov ID
- NCT07031778
- Acronym / sponsor ID
- SM / 3904/CEIH/2023
- Conditions
- Dimensional Changes, Bone Density
- Keywords
- simvastatin, bone density, dimensional changes, cbct scan
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| drug intervention: Gel SM | Experimental | Drug: Simvastatin30 lower third molars in whose alveolus post-extraction we will place simvastatin gel at 1.2%. |
| Drug intervention: Sm + collagen sponge | Active comparator | Drug: Simvastatin 10 mg30 lower third molars in whose alveolus post-extraction we will place a collagen sponge impregnated with saline solution containing 10 mg of simvastatin. |
| Control | Placebo comparator | Drug: Simvastatin Placebo30 lower third molars in whose alveolus post-extraction we will place a collagen sponge impregnated with gel without simvastatin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| SimvastatinSimvastatin gel with 1.2% simvastatin | Drug | drug intervention: Gel SM |
| Simvastatin 10 mgsponge of collagen impregned in saline solution with 10 mg of simvastatin | Drug | Drug intervention: Sm + collagen sponge |
| Simvastatin PlaceboCollagen sponge impregned in simvastatin placebo gel without simvastatin | Drug | Control |
Primary outcome
Dimensional changes
Time frame: From the time of extraction to when bone regeneration is supposed to be completed 12 weeks later.
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).
1 secondary outcome
Bone density
Time frame: Postextraction to the end of bone regeneration at 12 week latter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Results publication: PubMed 29859160Degala 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.
- Results publication: PubMed 33715258Cruz 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.
- Results publication: PubMed 35648294Deepanjali 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.
- Results publication: PubMed 35064813Diniz 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Simvastatin and Simvastatin 10 mg in people with Dimensional Changes and Bone Density, run by Universidad de Granada at 1 site in Spain.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 Jun 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 Spain. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manzano-Moreno FJ Francisco Javier Manzano-Moreno (+34651606228 ext. +34, fjmanza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimensional changes (time frame: From the time of extraction to when bone regeneration is supposed to be completed 12 weeks later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07031778, which also lists 4 linked publications.
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 22 Jun 2025.