Reversible PulpitisNCT04374214
Effect of Simvastatin as Pulpotomy Agent in Cariously Exposed Permanent Molars
A study testing Complete Pulpotomy using Mineral Trioxide Aggregate and Complete Pulpotomy using Simvastain -alphatricalcium phosphate in people with Reversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The study will compare the outcome of complete pulpotomy in mature permanent mandibular molars with deep carious lesions by using Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate as medicament agent Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- Complete Pulpotomy using Mineral Trioxide Aggregate and Complete Pulpotomy using Simvastain -alphatricalcium phosphate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient willing to participate in the study.
- Age group of 15 to 40 years
- Mature permanent mandibular molars with reversible pulpitis (positive response on the cold test and early response as compared to the adjacent or contralateral tooth)
- Teeth exhibiting occlusal pulp exposure from primary dental caries.
- Absence of periapical lesions assessed by radiographic examination.
- Tooth demonstrating no mobility or swelling and no tenderness to percussion or palpation
Who cannot join
- Primary teeth.
- Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract and furcation or apical radiolucency.
- Immune-compromised, pregnant and patients with any systemic disorder.
- Patients taking statin medication.
- Failure to obtain authorization from the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Simvastatin on Success of Pulpotomy in Cariously Exposed Permanent Molars: a Randomized Control Trial
The study will compare the outcome of complete pulpotomy in mature permanent mandibular molars with deep carious lesions by using Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate as medicament agent
Read the detailed description
After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure, its associated risks and benefits. Clinical diagnosis of reversible pulpitis will be established. Complete pulpotomy will be done in both groups. Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate will be used as pulpotomy agents. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1 year.
- Conditions
- Reversible Pulpitis
- Being tested
- Complete Pulpotomy using Mineral Trioxide Aggregate, Complete Pulpotomy using Simvastain -alphatricalcium phosphate
- Keywords
- Permanent teeth, Complete pulpotomy, Simvastatin -alpha tricalcium phosphate, Mineral Trioxide Aggregate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Pulpotomy using Mineral Trioxide AggregateProcedure or surgery
Inflammed coronal pulp tissue will be removed till the canal orifices and mineral trioxide aggregate placed over the amputated pulp stump.
Complete Pulpotomy using Simvastain -alphatricalcium phosphateProcedure or surgery
Inflammed coronal pulp tissue will be removed till the canal orifices and Simvastatin -alpha tricalcium phosphate placed over the amputated pulp stump.
| Study group | Role | What they receive |
|---|---|---|
| Complete Pulpotomy using mineral trioxide aggregate | Active comparator | Twenty-eight patients with curiously exposed permanent molars will be treated with complete pulpotomy by using Mineral Trioxide Aggregate. Receives: Procedure: Complete Pulpotomy using Mineral Trioxide Aggregate |
| Complete Pulpotomy using Simvastatin-alphatricalcium phosphate | Active comparator | Twenty-eight patients with curiously exposed permanent molars will be treated with complete pulpotomy by using Simvastatin -alphatricalcium phospahte. Receives: Procedure: Complete Pulpotomy using Simvastain -alphatricalcium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
criteria for successful clinical outcome will be absence of clinical sign and symtoms which include Absence of tenderness to percussion,tooth mobility of grade 1 or less.Absence of associated soft tissue swelling or tenderness to palpation.
Measured: Baseline to 12 months
Secondary outcomes (2)
Pain analysis
Assess the incidence and intensity of pain postoperatively at every 6 hours to 1 day till 7d ays using Visual Analogue scale.Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on the scale of 0-100mm
Measured: Baseline to 7 days
Radiographic success
Radiographic success will be evaluated by change in periapical index (PAI) scores.
PAI score 1: Normal periapical structure PAI score 2: Small changes in bone structure PAI score 3: Changes in bone structure with some mineral loss PAI score 4: Periodontis with well defined radiolucent area PAI score 5: Severe periodontitis with elements indicating expansion of lesion
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Dec 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reversible PulpitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sudeepender Gehlot, Principal investigator, PGIDS, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374214
- Sponsor's protocol ID
- Dr Sudeepender Gehlot
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gehlot S, Kumar V, Mittal S, Duhan J, Sangwan P, Arora M, Chauhan N. Effect of Simvastatin on Success of Pulpotomy in Carious Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomised Controlled Trial. Aust Endod J. 2026 Aug;52(2):411-419. doi: 10.1111/aej.70062. Epub 2026 Feb 6.
PubMed 41652862
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simvastatin on Success of Pulpotomy in Cariously Exposed Permanent Molars: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04374214
- Acronym / sponsor ID
- Dr Sudeepender Gehlot
- Conditions
- Reversible Pulpitis
- Keywords
- Permanent teeth, Complete pulpotomy, Simvastatin -alpha tricalcium phosphate, Mineral Trioxide Aggregate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 5 May 2020 (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 study will compare the outcome of complete pulpotomy in mature permanent mandibular molars with deep carious lesions by using Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate as medicament agent
Detailed description
After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure, its associated risks and benefits. Clinical diagnosis of reversible pulpitis will be established. Complete pulpotomy will be done in both groups. Mineral Trioxide Aggregate and Simvastatin -alpha tricalcium phosphate will be used as pulpotomy agents. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete Pulpotomy using mineral trioxide aggregate | Active comparator | Procedure: Complete Pulpotomy using Mineral Trioxide AggregateTwenty-eight patients with curiously exposed permanent molars will be treated with complete pulpotomy by using Mineral Trioxide Aggregate. |
| Complete Pulpotomy using Simvastatin-alphatricalcium phosphate | Active comparator | Procedure: Complete Pulpotomy using Simvastain -alphatricalcium phosphateTwenty-eight patients with curiously exposed permanent molars will be treated with complete pulpotomy by using Simvastatin -alphatricalcium phospahte. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patient willing to participate in the study.
- Age group of 15 to 40 years
- Mature permanent mandibular molars with reversible pulpitis (positive response on the cold test and early response as compared to the adjacent or contralateral tooth)
- Teeth exhibiting occlusal pulp exposure from primary dental caries.
- Absence of periapical lesions assessed by radiographic examination.
Key exclusion criteria (5 listed)
- Primary teeth.
- Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract and furcation or apical radiolucency.
- Immune-compromised, pregnant and patients with any systemic disorder.
- Patients taking statin medication.
- Failure to obtain authorization from the patient.
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 |
|---|---|---|
| Complete Pulpotomy using Mineral Trioxide AggregateInflammed coronal pulp tissue will be removed till the canal orifices and mineral trioxide aggregate placed over the amputated pulp stump. | Procedure or surgery | Complete Pulpotomy using mineral trioxide aggregate |
| Complete Pulpotomy using Simvastain -alphatricalcium phosphateInflammed coronal pulp tissue will be removed till the canal orifices and Simvastatin -alpha tricalcium phosphate placed over the amputated pulp stump. | Procedure or surgery | Complete Pulpotomy using Simvastatin-alphatricalcium phosphate |
Primary outcome
Clinical success
Time frame: Baseline to 12 months
criteria for successful clinical outcome will be absence of clinical sign and symtoms which include Absence of tenderness to percussion,tooth mobility of grade 1 or less.Absence of associated soft tissue swelling or tenderness to palpation.
2 secondary outcomes
Pain analysis
Time frame: Baseline to 7 days
Radiographic success
Time frame: Baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Derived from this study: PubMed 41652862Gehlot S, Kumar V, Mittal S, Duhan J, Sangwan P, Arora M, Chauhan N. Effect of Simvastatin on Success of Pulpotomy in Carious Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomised Controlled Trial. Aust Endod J. 2026 Aug;52(2):411-419. doi: 10.1111/aej.70062. Epub 2026 Feb 6.
Related trials for Reversible Pulpitis
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Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth
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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. This study is not recruiting at the moment.
Sudeepender Gehlot principal investigator
PGIDS, Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete Pulpotomy using Mineral Trioxide Aggregate and Complete Pulpotomy using Simvastain -alphatricalcium phosphate in people with Reversible Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 5 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: status not confirmed, as of the sponsor's last update on 5 May 2020. 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 India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: Baseline to 12 months). 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 NCT04374214, which also lists 1 linked publication.
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 5 May 2020.