Pulpal NecrosisPhase 2LSTRNCT07264842
Triple Antibiotic Paste vs Simvastatin for Lesion Sterilization and Tissue Repair in Primary Molars.
A Phase 2 study testing Lesion Sterilization and Tissue Repair using Simvastatin. and Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste. in people with Pulpal Necrosis, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This randomized, double-blinded, parallel-controlled clinical trial aims to compare the effectiveness of Triple Antibiotic Paste (TAP) and Simvastatin in Lesion Sterilization and Tissue Repair (LSTR) of primary molars with pulp necrosis. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Pulpal Necrosis
- What is being tested?
- Lesion Sterilization and Tissue Repair using Simvastatin. and Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Jun 2024to 31 Jul 2026
- Phase
- Phase 2
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Young, healthy patient, ranging in age from 5-8 years.
- Has parents/ guardians who give consent to allow their minor to participate in the study and willing to monitor their progress.
- Having maxillary and mandibular primary molars with:
- Spontaneous pain or tenderness to percussion.
- Deep cavity extending to the pulp chamber.
- Chronic Abscess or draining sinus.
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- Restorable.
- To be kept for less than a year.
- Irregular mobility that is not related to exfoliation.
Who cannot join
- Uncooperative patients.
- Children with a history of allergic reaction with antibiotics.
- Teeth with physiological root resorption but root length is more than two thirds, root canal obliteration, severe internal resorption, internal calcifications, or piercing into the bifurcation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dow International Dental College, Chanesar goth.
Karachi, Sindh, 75950
Muhammad Waleed Postgraduate Trainee - FCPS, BDS, 923222046451, waleedmumtaz.401194@duhs.edu.pk
Prof.Dr. Farah Naz Supervisor, FCPS, 03002345434, farah.naz@duhs.edu.pk
About this study
Official title: Triple Antibiotic Paste Versus Simvastatin for LSTR Treatment of Primary Molars With Pulp Necrosis: A Randomized Controlled Trial
This randomized, double-blinded, parallel-controlled clinical trial aims to compare the effectiveness of Triple Antibiotic Paste (TAP) and Simvastatin in Lesion Sterilization and Tissue Repair (LSTR) of primary molars with pulp necrosis.
A total of 60 children (aged 5-8 years) with non-vital primary molars will be recruited from the Department of Operative Dentistry and Endodontics, Dow International Dental College, Karachi. Participants will be randomly assigned to one of two groups:
Read more
Group 1 (Control): LSTR using Triple Antibiotic Paste (Ciprofloxacin + Metronidazole + Cefixime).
Group 2 (Intervention): LSTR using Simvastatin paste.
Both materials will be placed after non-instrumentation cleaning and sealed with glass ionomer cement, followed by stainless steel crown placement. Patients will be evaluated clinically and radiographically at 1, 2, and 3 months post-treatment.
Primary outcomes include clinical success (absence of pain, swelling, or sinus tract) and radiographic success (reduction or absence of periapical radiolucency). Data will be analyzed using SPSS v26, with chi-square and t-tests applied as appropriate; p < 0.05 will be considered significant.
This study seeks to determine whether Simvastatin, owing to its antibacterial, anti-inflammatory, and regenerative properties, can serve as a viable alternative to antibiotic-based LSTR in managing necrotic primary teeth.
- Conditions
- Pulpal Necrosis
- Being tested
- Lesion Sterilization and Tissue Repair using Simvastatin., Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.
- Keywords
- Lesion Sterilization and Tissue Repair
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lesion Sterilization and Tissue Repair using Simvastatin.Combination product
Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with simvastatin followed by sealed with the restoration.
Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.Combination product
Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with triple antibiotic paste followed by sealed with the restoration.
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Lesion Sterilization and Tissue Repair using Simvastatin. Receives: Combination Product: Lesion Sterilization and Tissue Repair using Simvastatin. |
| Triple Antibiotic Paste | Active comparator | Lesion Sterilization and Tissue Repair using triple antibiotic paste Receives: Combination Product: Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Change in pain through visual analog scale and size of swelling in millimeters will be assessed to measure clinical success.
Measured: 1 month, 2 month and 3 month.
Radiographic success
Change in radiolucency through the periapical index will be measured to assess radiographic success.
Measured: 1 month, 2 month and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start26 Jun 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpal NecrosisStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Mumtaz, Dow University of Health Sciences
- Investigators
- Prof.Dr. Farah Naz Biyabani, FCPS, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264842
- Sponsor's protocol ID
- 3379/DUHS//Approval/2024/175
- Acronym
- LSTR
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Antibiotic Paste Versus Simvastatin for LSTR Treatment of Primary Molars With Pulp Necrosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07264842
- Acronym / sponsor ID
- LSTR / 3379/DUHS//Approval/2024/175
- Conditions
- Pulpal Necrosis
- Keywords
- Lesion Sterilization and Tissue Repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 4 Dec 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.
This randomized, double-blinded, parallel-controlled clinical trial aims to compare the effectiveness of Triple Antibiotic Paste (TAP) and Simvastatin in Lesion Sterilization and Tissue Repair (LSTR) of primary molars with pulp necrosis.
A total of 60 children (aged 5-8 years) with non-vital primary molars will be recruited from the Department of Operative Dentistry and Endodontics, Dow International Dental College, Karachi. Participants will be randomly assigned to one of two groups:
Group 1 (Control): LSTR using Triple Antibiotic Paste (Ciprofloxacin + Metronidazole + Cefixime).
Group 2 (Intervention): LSTR using Simvastatin paste.
Both materials will be placed after non-instrumentation cleaning and sealed with glass ionomer cement, followed by stainless steel crown placement. Patients will be evaluated clinically and radiographically at 1, 2, and 3 months post-treatment.
Primary outcomes include clinical success (absence of pain, swelling, or sinus tract) and radiographic success (reduction or absence of periapical radiolucency). Data will be analyzed using SPSS v26, with chi-square and t-tests applied as appropriate; p < 0.05 will be considered significant.
This study seeks to determine whether Simvastatin, owing to its antibacterial, anti-inflammatory, and regenerative properties, can serve as a viable alternative to antibiotic-based LSTR in managing necrotic primary teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Combination Product: Lesion Sterilization and Tissue Repair using Simvastatin.Lesion Sterilization and Tissue Repair using Simvastatin. |
| Triple Antibiotic Paste | Active comparator | Combination Product: Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.Lesion Sterilization and Tissue Repair using triple antibiotic paste |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Young, healthy patient, ranging in age from 5-8 years.
- Has parents/ guardians who give consent to allow their minor to participate in the study and willing to monitor their progress.
- Having maxillary and mandibular primary molars with:
Key exclusion criteria (3 listed)
- Uncooperative patients.
- Children with a history of allergic reaction with antibiotics.
- Teeth with physiological root resorption but root length is more than two thirds, root canal obliteration, severe internal resorption, internal calcifications, or piercing into the bifurcation.
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 |
|---|---|---|
| Lesion Sterilization and Tissue Repair using Simvastatin.Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with simvastatin followed by sealed with the restoration. | Combination product | Simvastatin |
| Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with triple antibiotic paste followed by sealed with the restoration. | Combination product | Triple Antibiotic Paste |
Primary outcome
Clinical Success
Time frame: 1 month, 2 month and 3 month.
Change in pain through visual analog scale and size of swelling in millimeters will be assessed to measure clinical success.
Radiographic success
Time frame: 1 month, 2 month and 3 month
Change in radiolucency through the periapical index will be measured to assess radiographic success.
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 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Effect of Apical Patency on Periapical Lesion Healing
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Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
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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.
Prof.Dr. Farah Naz Biyabani, FCPS study director
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lesion Sterilization and Tissue Repair using Simvastatin. and Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste. in people with Pulpal Necrosis, run by Dow University of Health Sciences at 1 site in Pakistan.
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 9 inclusion and 3 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 10 Mar 2026. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Muhammad Waleed Postgraduate Trainee, FCPS (923222046451, waleedmumtaz.401194@duhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: 1 month, 2 month and 3 month.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.