Pulpal NecrosisLSTR-PULPNCT07026435
Comparison of LSTR and Pulpectomy in Primary Molars of Pediatric Patients (LSTR-PULP)
A study testing LSTR and Pulpectomy in people with Pulpal Necrosis and Dental Caries, run by taymour abuawwad at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effectiveness of Lesion Sterilization and Tissue Repair (LSTR) with conventional pulpectomy in treating pulpal lesions in primary molars of pediatric patients aged 4 to 10 years. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Pulpal Necrosis, Dental Caries, Periapical Periodontitis
- What is being tested?
- LSTR and Pulpectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Aug 2024to 10 Nov 2025
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 10 years.
- Presence of at least one primary molar with pulpal involvement requiring endodontic treatment.
- Good general health without systemic conditions.
- Signed informed consent from parent or legal guardian.
Who cannot join
- Children with systemic diseases or immune-compromising conditions.
- Known allergies to any of the materials or antibiotics used in the study.
- Uncooperative behavior preventing dental treatment under normal clinical conditions.
- Teeth with non-restorable crown structure or excessive root resorption.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Dentistry
Erzurum, Yakutiye, 25240
About this study
Official title: Comparison of Lesion Sterilization and Tissue Repair Technique With Conventional Pulpectomy in the Treatment of Pulpal Lesions in Primary Molars in Children
This study aims to compare the effectiveness of Lesion Sterilization and Tissue Repair (LSTR) with conventional pulpectomy in treating pulpal lesions in primary molars of pediatric patients aged 4 to 10 years. LSTR is a minimally invasive method that uses antibiotic paste to disinfect infected tissue without full canal instrumentation. Children participating in this study will receive either the LSTR technique or standard pulpectomy, and the clinical and radiographic success of both treatments will be evaluated over a 12-month period. The goal is to determine whether LSTR is a safe and effective alternative to pulpectomy in primary teeth.
Read the detailed description
This is a prospective, comparative clinical trial conducted at Atatürk University, Department of Pediatric Dentistry, Erzurum, Turkey. The study compares two endodontic treatment methods for primary molars with pulpal lesions in children aged 4 to 10 years. A total of 110 primary molar teeth from 98 pediatric patients were included. Teeth were assigned to two main treatment groups: the experimental group receiving Lesion Sterilization and Tissue Repair (LSTR) and the control group receiving conventional pulpectomy. Each group was further divided into two subgroups based on the type of final restoration - stainless steel crown (SSC) or compomer - resulting in four treatment-restoration combinations: LSTR + SSC, LSTR + compomer, pulpectomy + SSC, and pulpectomy + compomer. Restoration type was determined based on patient cooperation and parental preference.
The LSTR group was treated with a combination of ciprofloxacin and metronidazole antibiotics mixed with iodoform-calcium hydroxide paste (Viopex), applied to the canal orifices without mechanical instrumentation. The pulpectomy group received standard chemomechanical canal debridement and obturation with iodoform-calcium hydroxide paste. Both groups were subsequently restored with either SSC or compomer.
Patients were followed up clinically and radiographically at 3, 6, and 12 months. Clinical parameters assessed included spontaneous pain, percussion sensitivity, abscess, fistula, and pathological mobility. Radiographic parameters included periapical and interradicular lesion resolution, internal root resorption, and external root resorption. Overall tooth survival was evaluated using Kaplan-Meier survival analysis and Log-Rank test. The primary objective was to assess whether LSTR achieves similar clinical and radiographic success compared to conventional pulpectomy, and to determine the effect of restoration type on long-term treatment outcomes.
- Conditions
- Pulpal Necrosis, Dental Caries, Periapical Periodontitis, Pediatric Dentistry, Primary Tooth Pulpectomy
- Being tested
- LSTR, Pulpectomy
- Keywords
- LSTR, Pulpectomy, Primary teeth, Triple antibiotic paste
- Medical subject headings
- Dental Pulp Necrosis, Dental Caries, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSTRProcedure or surgery
Lesion Sterilization and Tissue Repair (LSTR) is a minimally invasive pulp therapy using ciprofloxacin and metronidazole mixed with iodoform-calcium hydroxide, without canal instrumentation. The access cavity is sealed and restored with SSC or compomer.
PulpectomyProcedure or surgery
Pulpectomy includes mechanical canal preparation, irrigation, and obturation using iodoform-calcium hydroxide paste, followed by final restoration with stainless steel crown or compomer.
| Study group | Role | What they receive |
|---|---|---|
| LSTR Group | Experimental | Children will receive the LSTR (Lesion Sterilization and Tissue Repair) procedure, which includes applying a mixture of ciprofloxacin and metronidazole with iodoform-calcium hydroxide paste to the pulp chamber without canal instrumentation. Restoration will be done using a stainless steel crown or compomer. Receives: Procedure: LSTR |
| Pulpectomy Group | Active comparator | Children will receive conventional pulpectomy involving mechanical canal instrumentation and obturation with iodoform-calcium hydroxide paste. Restoration will be completed with a stainless steel crown or compomer based on clinical conditions. Receives: Procedure: Pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate of Treated Primary Molars
Clinical success is defined as absence of pain, swelling, sinus tract, and pathological mobility assessed through standardized clinical examination by a pediatric dentist.
Measured: At 3, 6, and 12 months post-treatment
Secondary outcomes (1)
Radiographic Healing Rate of Treated Primary Molars
Radiographic healing is defined as the resolution of periapical or interradicular radiolucency, and the absence of pathological root resorption progression. Radiographic assessment was performed by evaluating the presence or absence of periapical/interradicular lesions, internal root resorption, and external root resorption on digital periapical radiographs. Note: The Periapical Index (PAI) scoring system was originally planned but was not applied due to the radiographic characteristics of primary teeth and the nature of the lesions encountered; descriptive radiographic assessment was used instead."
Measured: At 6 and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start16 Aug 2024
- Primary completion14 Sep 2025
- Study completion10 Nov 2025
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- taymour abuawwad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, taymour abuawwad, Ataturk University
- Investigators
- Sera DERELİOĞLU, DDS, PhD, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026435
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/477
- Other IDs
- TDK-2024-14564
- Acronym
- LSTR-PULP
- Status last verified
- May 2026
- First submitted
- 19 May 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lesion Sterilization and Tissue Repair Technique With Conventional Pulpectomy in the Treatment of Pulpal Lesions in Primary Molars in Children
- ClinicalTrials.gov ID
- NCT07026435
- Acronym / sponsor ID
- LSTR-PULP / B.30.2.ATA.0.01.00/477
- Conditions
- Pulpal Necrosis, Dental Caries, Periapical Periodontitis, Pediatric Dentistry, Primary Tooth Pulpectomy
- Keywords
- LSTR, Pulpectomy, Primary teeth, Triple antibiotic paste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- taymour abuawwadUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 14 Sep 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 18 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.
This study aims to compare the effectiveness of Lesion Sterilization and Tissue Repair (LSTR) with conventional pulpectomy in treating pulpal lesions in primary molars of pediatric patients aged 4 to 10 years. LSTR is a minimally invasive method that uses antibiotic paste to disinfect infected tissue without full canal instrumentation. Children participating in this study will receive either the LSTR technique or standard pulpectomy, and the clinical and radiographic success of both treatments will be evaluated over a 12-month period. The goal is to determine whether LSTR is a safe and effective alternative to pulpectomy in primary teeth.
Detailed description
This is a prospective, comparative clinical trial conducted at Atatürk University, Department of Pediatric Dentistry, Erzurum, Turkey. The study compares two endodontic treatment methods for primary molars with pulpal lesions in children aged 4 to 10 years. A total of 110 primary molar teeth from 98 pediatric patients were included. Teeth were assigned to two main treatment groups: the experimental group receiving Lesion Sterilization and Tissue Repair (LSTR) and the control group receiving conventional pulpectomy. Each group was further divided into two subgroups based on the type of final restoration - stainless steel crown (SSC) or compomer - resulting in four treatment-restoration combinations: LSTR + SSC, LSTR + compomer, pulpectomy + SSC, and pulpectomy + compomer. Restoration type was determined based on patient cooperation and parental preference.
The LSTR group was treated with a combination of ciprofloxacin and metronidazole antibiotics mixed with iodoform-calcium hydroxide paste (Viopex), applied to the canal orifices without mechanical instrumentation. The pulpectomy group received standard chemomechanical canal debridement and obturation with iodoform-calcium hydroxide paste. Both groups were subsequently restored with either SSC or compomer.
Patients were followed up clinically and radiographically at 3, 6, and 12 months. Clinical parameters assessed included spontaneous pain, percussion sensitivity, abscess, fistula, and pathological mobility. Radiographic parameters included periapical and interradicular lesion resolution, internal root resorption, and external root resorption. Overall tooth survival was evaluated using Kaplan-Meier survival analysis and Log-Rank test. The primary objective was to assess whether LSTR achieves similar clinical and radiographic success compared to conventional pulpectomy, and to determine the effect of restoration type on long-term treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSTR Group | Experimental | Procedure: LSTRChildren will receive the LSTR (Lesion Sterilization and Tissue Repair) procedure, which includes applying a mixture of ciprofloxacin and metronidazole with iodoform-calcium hydroxide paste to the pulp chamber without canal instrumentation. Restoration will be done using a stainless steel crown or compomer. |
| Pulpectomy Group | Active comparator | Procedure: PulpectomyChildren will receive conventional pulpectomy involving mechanical canal instrumentation and obturation with iodoform-calcium hydroxide paste. Restoration will be completed with a stainless steel crown or compomer based on clinical conditions. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4 to 10 years.
- Presence of at least one primary molar with pulpal involvement requiring endodontic treatment.
- Good general health without systemic conditions.
- Signed informed consent from parent or legal guardian.
Key exclusion criteria (4 listed)
- Children with systemic diseases or immune-compromising conditions.
- Known allergies to any of the materials or antibiotics used in the study.
- Uncooperative behavior preventing dental treatment under normal clinical conditions.
- Teeth with non-restorable crown structure or excessive root resorption.
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 |
|---|---|---|
| LSTRLesion Sterilization and Tissue Repair (LSTR) is a minimally invasive pulp therapy using ciprofloxacin and metronidazole mixed with iodoform-calcium hydroxide, without canal instrumentation. The access cavity is sealed and restored with SSC or compomer. | Procedure or surgery | LSTR Group |
| PulpectomyPulpectomy includes mechanical canal preparation, irrigation, and obturation using iodoform-calcium hydroxide paste, followed by final restoration with stainless steel crown or compomer. | Procedure or surgery | Pulpectomy Group |
Primary outcome
Clinical Success Rate of Treated Primary Molars
Time frame: At 3, 6, and 12 months post-treatment
Clinical success is defined as absence of pain, swelling, sinus tract, and pathological mobility assessed through standardized clinical examination by a pediatric dentist.
1 secondary outcome
Radiographic Healing Rate of Treated Primary Molars
Time frame: At 6 and 12 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
Related trials for Pulpal Necrosis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
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.
Sera DERELİOĞLU, DDS, PhD principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSTR and Pulpectomy in people with Pulpal Necrosis and Dental Caries, run by taymour abuawwad at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 May 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Rate of Treated Primary Molars (time frame: At 3, 6, and 12 months post-treatment). 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 29 May 2026.