Pulp NecrosisNCT07836686

CLINICAL AND RADIOGRAPHIC SUCCESS OF MODIFIED LSTR TECHNIQUES IN PRIMARY SECOND MOLARS

A study testing 3Mix-MP Antibiotic Paste, 3Mix-NS Antibiotic Paste and 2Mix-MP Antibiotic Paste in people with Pulp Necrosis and Irreversible Pulpitis, run by Uşak University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 11 years
Conditions the study is for: Pulp Necrosis, Irreversible Pulpitis
What is being tested?: 3Mix-MP Antibiotic Paste, 3Mix-NS Antibiotic Paste and 2Mix-MP Antibiotic Paste
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 26 Nov 2024to 5 Mar 2026
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 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children aged 4-11 years.
Systemically healthy children.
Presence of deep caries, pulp necrosis, or irreversible pulpitis in a mandibular primary second molar indicated for LSTR treatment.
Patients unsuitable for conventional pulpectomy due to poor cooperation.
At least 6 months remaining before physiological exfoliation of the affected tooth.
Root resorption not exceeding one-third of the root length.

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No furcation perforation.
Furcation radiolucency not extending to the permanent tooth germ.
Sufficient remaining tooth structure for restoration.
Parent/legal guardian willing to provide informed consent.

Who cannot join

Risk of infective endocarditis.
Known allergy to any antibiotic used in the study.
Root resorption exceeding one-third of the root length.
Extensive furcation involvement extending toward the permanent tooth germ.
Insufficient remaining tooth structure for restoration.
Parent/legal guardian declining informed consent.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Uşak University Faculty of Dentistry
Uşak, Uşak

Other trials in Turkey (Türkiye)

About this study

Official title: EVALUATION OF THE CLINICAL AND RADIOGRAPHIC SUCCESS OF VARIOUS MODIFICATIONS OF THE LESION STERILIZATION AND TISSUE REPAIR TECHNIQUE IN PRIMARY SECOND MOLAR TEETH

This study aimed to evaluate and compare the clinical and radiographic success of different antibiotic and vehicle modifications of the Lesion Sterilization and Tissue Repair (LSTR) technique in infected mandibular primary second molars. The study included systemically healthy children aged 4-11 years. Participants were assigned to four treatment groups according to the antibiotic combination (3Mix or 2Mix) and vehicle used [Macrogol-Propylene Glycol (MP) or normal saline (NS)]: 3Mix-MP, 3Mix-NS, 2Mix-MP, and 2Mix-NS. Clinical outcomes were evaluated at 3, 6, and 12 months after treatment, and radiographic outcomes were evaluated at 6 and 12 months. The clinical and radiographic success of the four LSTR modifications was compared over the 12-month follow-up period.

Read the detailed description

This study was conducted to evaluate and compare the clinical and radiographic success of different antibiotic and vehicle modifications of the Lesion Sterilization and Tissue Repair (LSTR) technique in infected mandibular primary second molars.

A total of 64 systemically healthy children aged 4-11 years were included in the study. The cases were assigned to four treatment groups according to the antibiotic combination (3Mix or 2Mix) and the vehicle used [Macrogol-Propylene Glycol (MP) or Normal saline (NS)]. The four treatment groups were 3Mix-MP, 3Mix-NS, 2Mix-MP, and 2Mix-NS.

Following LSTR treatment, clinical evaluations were performed at 3, 6, and 12 months, while radiographic evaluations were performed at 6 and 12 months. Clinical and radiographic findings were assessed at the specified follow-up periods to determine treatment success and to compare the outcomes of the four LSTR modifications over a 12-month follow-up period.

Conditions: Pulp Necrosis, Irreversible Pulpitis
Being tested: 3Mix-MP Antibiotic Paste, 3Mix-NS Antibiotic Paste, 2Mix-MP Antibiotic Paste, 2Mix-NS Antibiotic Paste
Keywords: Double Antibiotic Paste, LSTR, Primary Molar Teeth, Triple Antibiotic Paste
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.

3Mix-MP Antibiotic PasteDrug
The 3Mix antibiotic powder consisted of metronidazole, ciprofloxacin, and clindamycin mixed in a 1:1:1 ratio. Macrogol and propylene glycol were mixed in a 1:1 ratio to prepare the vehicle. Immediately before application, the antibiotic powder and the vehicle were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.
3Mix-NS Antibiotic PasteDrug
The 3Mix antibiotic powder consisted of metronidazole, ciprofloxacin, and clindamycin mixed in a 1:1:1 ratio. Normal saline (NS) was used as the vehicle. Immediately before application, the antibiotic powder and normal saline were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.
2Mix-MP Antibiotic PasteDrug
The 2Mix antibiotic powder consisted of metronidazole and ciprofloxacin mixed in a 1:1 ratio. Macrogol and propylene glycol were mixed in a 1:1 ratio to prepare the vehicle. Immediately before application, the antibiotic powder and the vehicle were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.
2Mix-NS Antibiotic PasteDrug
The 2Mix antibiotic powder consisted of metronidazole and ciprofloxacin mixed in a 1:1 ratio. Normal saline (NS) was used as the vehicle. Immediately before application, the antibiotic powder and normal saline were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.

Study groups in NCT07836686
Study group	Role	What they receive
3Mix-MP	Experimental	Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle. Receives: Drug: 3Mix-MP Antibiotic Paste
3Mix-NS	Experimental	Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with normal saline (NS) as the vehicle. Receives: Drug: 3Mix-NS Antibiotic Paste
2Mix-MP	Experimental	Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle. Receives: Drug: 2Mix-MP Antibiotic Paste
2Mix-NS	Experimental	Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with normal saline (NS) as the vehicle. Receives: Drug: 2Mix-NS Antibiotic Paste

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Success of LSTR Treatment
Clinical success was defined as the absence of pain or tenderness, swelling or fistula, pathological mobility, and tenderness to percussion. The presence of any of these signs or symptoms was considered clinical failure
Measured: 3, 6, and 12 months after treatment
Radiographic Success of LSTR Treatment
Radiographic success was defined as stabilization, reduction, or complete resolution of existing interradicular and periradicular radiolucency, with no development of new radiographic lesions. Failure to meet any of these criteria was considered radiographic failure.
Measured: 6 and 12 months after treatment
Overall Success of LSTR Treatment
Overall treatment success was defined as fulfillment of both the clinical and radiographic success criteria. A case was considered unsuccessful if either the clinical or radiographic success criteria were not met.
Measured: 6 and 12 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 20245 Mar 2026

First posted23 Sep 2026
Study start26 Nov 2024
Primary completion5 Mar 2026
Study completion5 Mar 2026

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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Participants were assigned to four parallel treatment groups according to their order of presentation to the clinic. The groups differed according to the antibiotic combination (3Mix or 2Mix) and the vehicle used (Macrogol-Propylene Glycol or Normal saline). Participants were followed for 12 months to compare the clinical and radiographic outcomes of the four LSTR protocols.
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07836686
Sponsor's protocol ID: 492-492-10
Status last verified: Sep 2026
First submitted: 17 Sep 2026
Last updated: 29 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
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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
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All Pulp Necrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EVALUATION OF THE CLINICAL AND RADIOGRAPHIC SUCCESS OF VARIOUS MODIFICATIONS OF THE LESION STERILIZATION AND TISSUE REPAIR TECHNIQUE IN PRIMARY SECOND MOLAR TEETH
ClinicalTrials.gov ID: NCT07836686
Acronym / sponsor ID: 492-492-10
Conditions: Pulp Necrosis, Irreversible Pulpitis
Keywords: Double Antibiotic Paste, LSTR, Primary Molar Teeth, Triple Antibiotic Paste
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Uşak UniversityUniversity, hospital or other
Study start: 26 Nov 2024 (actual)
Primary completion: 5 Mar 2026 (actual)
Study completion: 5 Mar 2026 (actual)
First posted: 23 Sep 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Participants were assigned to four parallel treatment groups according to their order of presentation to the clinic. The groups differed according to the antibiotic combination (3Mix or 2Mix) and the vehicle used (Macrogol-Propylene Glycol or Normal saline). Participants were followed for 12 months to compare the clinical and radiographic outcomes of the four LSTR protocols.

Arm	Type	Receives
3Mix-MP	Experimental	Drug: 3Mix-MP Antibiotic PasteParticipants in this arm received LSTR treatment using the 3Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.
3Mix-NS	Experimental	Drug: 3Mix-NS Antibiotic PasteParticipants in this arm received LSTR treatment using the 3Mix antibiotic combination with normal saline (NS) as the vehicle.
2Mix-MP	Experimental	Drug: 2Mix-MP Antibiotic PasteParticipants in this arm received LSTR treatment using the 2Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.
2Mix-NS	Experimental	Drug: 2Mix-NS Antibiotic PasteParticipants in this arm received LSTR treatment using the 2Mix antibiotic combination with normal saline (NS) as the vehicle.

Who may qualify

Ages: 4 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Children aged 4-11 years.
Systemically healthy children.
Presence of deep caries, pulp necrosis, or irreversible pulpitis in a mandibular primary second molar indicated for LSTR treatment.
Patients unsuitable for conventional pulpectomy due to poor cooperation.
At least 6 months remaining before physiological exfoliation of the affected tooth.

Key exclusion criteria (6 listed)

Risk of infective endocarditis.
Known allergy to any antibiotic used in the study.
Root resorption exceeding one-third of the root length.
Extensive furcation involvement extending toward the permanent tooth germ.
Insufficient remaining tooth structure for restoration.

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
3Mix-MP Antibiotic PasteThe 3Mix antibiotic powder consisted of metronidazole, ciprofloxacin, and clindamycin mixed in a 1:1:1 ratio. Macrogol and propylene glycol were mixed in a 1:1 ratio to prepare the vehicle. Immediately before application, the antibiotic powder and the vehicle were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.	Drug	3Mix-MP
3Mix-NS Antibiotic PasteThe 3Mix antibiotic powder consisted of metronidazole, ciprofloxacin, and clindamycin mixed in a 1:1:1 ratio. Normal saline (NS) was used as the vehicle. Immediately before application, the antibiotic powder and normal saline were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.	Drug	3Mix-NS
2Mix-MP Antibiotic PasteThe 2Mix antibiotic powder consisted of metronidazole and ciprofloxacin mixed in a 1:1 ratio. Macrogol and propylene glycol were mixed in a 1:1 ratio to prepare the vehicle. Immediately before application, the antibiotic powder and the vehicle were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.	Drug	2Mix-MP
2Mix-NS Antibiotic PasteThe 2Mix antibiotic powder consisted of metronidazole and ciprofloxacin mixed in a 1:1 ratio. Normal saline (NS) was used as the vehicle. Immediately before application, the antibiotic powder and normal saline were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.	Drug	2Mix-NS

Primary outcome

Clinical Success of LSTR Treatment
Time frame: 3, 6, and 12 months after treatment
Clinical success was defined as the absence of pain or tenderness, swelling or fistula, pathological mobility, and tenderness to percussion. The presence of any of these signs or symptoms was considered clinical failure
Radiographic Success of LSTR Treatment
Time frame: 6 and 12 months after treatment
Radiographic success was defined as stabilization, reduction, or complete resolution of existing interradicular and periradicular radiolucency, with no development of new radiographic lesions. Failure to meet any of these criteria was considered radiographic failure.
Overall Success of LSTR Treatment
Time frame: 6 and 12 months after treatment
Overall treatment success was defined as fulfillment of both the clinical and radiographic success criteria. A case was considered unsuccessful if either the clinical or radiographic success criteria were not met.

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 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Pulp 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
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no 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

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.

Merve ALKIŞ, DDS study director

Usak Universty

Merve AKAR, DDS principal investigator

Usak Universty

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 6 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 Sep 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 of LSTR Treatment (time frame: 3, 6, and 12 months after treatment). The study lists 3 primary outcomes in all. 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 NCT07836686.

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 Sep 2026.