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Not yet recruitingNCT07475364LSTRUpdated Mar 19, 2026

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 interventional study of Group A - LSTR Therapy (CTZ Paste) and Group B - ZOE Pulpectomy in Pulp Necrosis, sponsored by University of Faisalabad. Not yet recruiting. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by University of Faisalabad · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Pulp Necrosis

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Keywords

  • LSTR therapy
  • primary molars
  • pulp therapy
03

In context

Dental Pulp Necrosis

149 studies on the registry are indexed under Dental Pulp Necrosis; 39 are open to participants now.

This study's planned enrollment of 180 is above the median of 44 across 139 interventional studies indexed under Dental Pulp Necrosis.

Browse Dental Pulp Necrosis studies →

Lead sponsor

University of Faisalabad is the lead sponsor of 83 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    • 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

Exclusion criteria

Exclusion Criteria:

    • 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    LSTR therapy

    Participants in this group receive CTZ antibiotic paste placed in the pulp chamber after irrigation.

    Drug: Group A - LSTR Therapy (CTZ Paste)

  • Active comparator
    Zinc Oxide Eugenol (ZOE) Pulpectomy

    Participants in this group receive conventional pulpectomy with ZOE paste placed in the root canals.

    Procedure: Group B - ZOE Pulpectomy

Interventions

  • DrugGroup 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.

  • ProcedureGroup B - ZOE Pulpectomy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 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.

    Time frame: baseline and 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 31, 2025

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07475364
Lead sponsor
University of Faisalabad
Responsible party
Hira Zaman (Assistant Professor, University of Faisalabad) — Principal investigator
First posted
Mar 16, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Mar 19, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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