Pulp NecrosisPhase 1/2LSTRNCT07475364
Lesion Sterilization and Tissue Repair Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for Treatment of Primary Molars With Pulp Necrosis
A Phase 1/2 study testing Group A - LSTR Therapy (CTZ Paste) and Group B - ZOE Pulpectomy in people with Pulp Necrosis, run by University of Faisalabad.
Trial summary
The goal of this clinical trial is to compare the efficacy of lesion sterilization and tissue repair (LSTR) antibiotic paste versus zinc oxide eugenol (ZOE) pulpectomy for the treatment of primary molars with pulp necrosis in pediatric patients. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Pulp Necrosis
- What is being tested?
- Group A - LSTR Therapy (CTZ Paste) and Group B - ZOE Pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Phase 1/2
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Children of both genders
- 4 years and 10 years
- Pulp necrosis in mandibular primary molars with minimum of 2/3 of the roots
- Consent from Parents/Guardian of children.
- Sufficient crown structure for restoration
Who cannot join
- • Children who have a physical or mental change.
- Involving systemic illnesses.
- History of allergy to drugs being utilized
- Antibiotics use within three months
- Teeth with aberrant root resorption or pulp canal obliteration on periapical radiography
About this study
The goal of this clinical trial is to compare the efficacy of lesion sterilization and tissue repair (LSTR) antibiotic paste versus zinc oxide eugenol (ZOE) pulpectomy for the treatment of primary molars with pulp necrosis in pediatric patients.
The main questions it aims to answer are:
Read more
- Is LSTR antibiotic paste (CTZ paste) effective in treating primary molars with pulp necrosis?
- Is ZOE pulpectomy effective in treating primary molars with pulp necrosis, and how does its efficacy compare with LSTR therapy?
Researchers will compare LSTR therapy (Group A) with ZOE pulpectomy (Group B) to determine which treatment provides better clinical and radiographic outcomes after six months.
Participants will:
- Be randomly assigned to one of the two treatment groups after diagnosis of pulp necrosis in primary molars.
- Receive treatment under standard behavior management techniques with local anesthesia following topical application of 2% lignocaine gel and rubber dam isolation.
- Undergo either Lesion Sterilization and Tissue Repair (LSTR) therapy with CTZ paste or zinc oxide eugenol (ZOE) pulpectomy according to group allocation.
- Return for a clinical and radiographic follow-up evaluation after six months to assess treatment outcomes.
- Allow researchers to record their clinical findings and radiographic results to evaluate the efficacy of both treatment methods.
- Conditions
- Pulp Necrosis
- Being tested
- Group A - LSTR Therapy (CTZ Paste), Group B - ZOE Pulpectomy
- Keywords
- LSTR therapy, primary molars, pulp therapy
- 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.
Group A - LSTR Therapy (CTZ Paste)Drug
Placement of CTZ antibiotic paste (chloramphenicol, tetracycline, zinc oxide mixed with eugenol) in the pulp chamber after irrigation with 3% sodium hypochlorite, followed by restoration with resin-modified glass ionomer cement.
Group B - ZOE PulpectomyProcedure or surgery
Intervention: Conventional pulpectomy including working length determination, canal debridement with K-files and 3% sodium hypochlorite irrigation, followed by obturation with zinc oxide eugenol paste and final restoration with resin-modified glass ionomer cement.
| Study group | Role | What they receive |
|---|---|---|
| LSTR therapy | Experimental | Participants in this group receive CTZ antibiotic paste placed in the pulp chamber after irrigation. Receives: Drug: Group A - LSTR Therapy (CTZ Paste) |
| Zinc Oxide Eugenol (ZOE) Pulpectomy | Active comparator | Participants in this group receive conventional pulpectomy with ZOE paste placed in the root canals. Receives: Procedure: Group B - ZOE Pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Clinical Success
Clinical success will be assessed based on the absence of sinus tract, soft tissue swelling, or edema associated with the treated primary molar during follow-up clinical examination.
Measured: 6 months
Number of Participants with Radiographic Success
Radiographic success will be assessed by reduction or complete disappearance of the initial periapical radiolucency and absence of any newly developed radiolucency on follow-up periapical radiographs of the treated tooth.
Measured: 6 months after treatment
Secondary outcomes (1)
Reduction in Periapical Radiolucency
Change in the size of periapical radiolucency from baseline to follow-up radiographs in treated primary molars.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Zaman, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475364
- Sponsor's protocol ID
- TUF/IRB/30/2025
- Acronym
- LSTR
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesion Sterilization and Tissue Repair Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for Treatment of Primary Molars With Pulp Necrosis
- ClinicalTrials.gov ID
- NCT07475364
- Acronym / sponsor ID
- LSTR / TUF/IRB/30/2025
- Conditions
- Pulp Necrosis
- Keywords
- LSTR therapy, primary molars, pulp therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 16 Mar 2026 (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 compare the efficacy of lesion sterilization and tissue repair (LSTR) antibiotic paste versus zinc oxide eugenol (ZOE) pulpectomy for the treatment of primary molars with pulp necrosis in pediatric patients.
The main questions it aims to answer are:
- Is LSTR antibiotic paste (CTZ paste) effective in treating primary molars with pulp necrosis?
- Is ZOE pulpectomy effective in treating primary molars with pulp necrosis, and how does its efficacy compare with LSTR therapy?
Researchers will compare LSTR therapy (Group A) with ZOE pulpectomy (Group B) to determine which treatment provides better clinical and radiographic outcomes after six months.
Participants will:
- Be randomly assigned to one of the two treatment groups after diagnosis of pulp necrosis in primary molars.
- Receive treatment under standard behavior management techniques with local anesthesia following topical application of 2% lignocaine gel and rubber dam isolation.
- Undergo either Lesion Sterilization and Tissue Repair (LSTR) therapy with CTZ paste or zinc oxide eugenol (ZOE) pulpectomy according to group allocation.
- Return for a clinical and radiographic follow-up evaluation after six months to assess treatment outcomes.
- Allow researchers to record their clinical findings and radiographic results to evaluate the efficacy of both treatment methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSTR therapy | Experimental | Drug: Group A - LSTR Therapy (CTZ Paste)Participants in this group receive CTZ antibiotic paste placed in the pulp chamber after irrigation. |
| Zinc Oxide Eugenol (ZOE) Pulpectomy | Active comparator | Procedure: Group B - ZOE PulpectomyParticipants in this group receive conventional pulpectomy with ZOE paste placed in the root canals. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Children of both genders
Key exclusion criteria (5 listed)
- • Children who have a physical or mental change.
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 |
|---|---|---|
| Group A - LSTR Therapy (CTZ Paste)Placement of CTZ antibiotic paste (chloramphenicol, tetracycline, zinc oxide mixed with eugenol) in the pulp chamber after irrigation with 3% sodium hypochlorite, followed by restoration with resin-modified glass ionomer cement. | Drug | LSTR therapy |
| Group B - ZOE PulpectomyIntervention: Conventional pulpectomy including working length determination, canal debridement with K-files and 3% sodium hypochlorite irrigation, followed by obturation with zinc oxide eugenol paste and final restoration with resin-modified glass ionomer cement. | Procedure or surgery | Zinc Oxide Eugenol (ZOE) Pulpectomy |
Primary outcome
Number of Participants with Clinical Success
Time frame: 6 months
Clinical success will be assessed based on the absence of sinus tract, soft tissue swelling, or edema associated with the treated primary molar during follow-up clinical examination.
Number of Participants with Radiographic Success
Time frame: 6 months after treatment
Radiographic success will be assessed by reduction or complete disappearance of the initial periapical radiolucency and absence of any newly developed radiolucency on follow-up periapical radiographs of the treated tooth.
1 secondary outcome
Reduction in Periapical Radiolucency
Time frame: baseline and 6 months
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 19 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Group A - LSTR Therapy (CTZ Paste) and Group B - ZOE Pulpectomy in people with Pulp Necrosis, run by University of Faisalabad.
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 5 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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Number of Participants with Clinical Success (time frame: 6 months). 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 19 Mar 2026.