ClinicalTrials.gg
CompletedNCT07836686Updated Sep 29, 2026

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

An interventional study of 3Mix-MP Antibiotic Paste and 3Mix-NS Antibiotic Paste in Pulp Necrosis and Irreversible Pulpitis, sponsored by Uşak University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Uşak University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Nov 2024, registered Sep 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
4 Years to 11 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Dental Pulp Necrosis with a site in Turkey — 3 open to participants now, 5 under way, none of them phase 3. Dental Pulp Necrosis · Turkey.

Enrollment
8th of 15
64 · median 64
Started
2024
with 7 others
No phase
14 of 20
3 open now
Registered
18th of 20
by date

Among the 20 studies in Dental Pulp Necrosis with a site in Turkey, this one is the 8th largest by enrollment of the 15 interventional ones that give a count, is one of 8 that started in 2024, is one of 14 with no phase, and was the 18th registered.

Dental Pulp Necrosis

157 studies on the registry are indexed under Dental Pulp Necrosis; 44 are open to participants now.

Browse Dental Pulp Necrosis studies →

Open to participants now

3 of the 20 studies in Dental Pulp Necrosis with a site in Turkey are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 15 Dental Pulp Necrosis studies recruiting now, 6 (40%) set no upper age limit and 7 (47%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.

This study: 4 Years to 11 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Dental Pulp Necrosis with a site in Turkey, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Pulp Necrosis
  • Irreversible Pulpitis

Browse trials for

Keywords

  • Double Antibiotic Paste
  • LSTR
  • Primary Molar Teeth
  • Triple Antibiotic Paste
04

Who can participate

Ages eligible
4 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    3Mix-MP

    Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.

    Drug: 3Mix-MP Antibiotic Paste

  • Experimental
    3Mix-NS

    Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with normal saline (NS) as the vehicle.

    Drug: 3Mix-NS Antibiotic Paste

  • Experimental
    2Mix-MP

    Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.

    Drug: 2Mix-MP Antibiotic Paste

  • Experimental
    2Mix-NS

    Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with normal saline (NS) as the vehicle.

    Drug: 2Mix-NS Antibiotic Paste

Interventions

  • Drug3Mix-MP Antibiotic Paste

    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.

  • Drug3Mix-NS Antibiotic Paste

    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.

  • Drug2Mix-MP Antibiotic Paste

    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.

  • Drug2Mix-NS Antibiotic Paste

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3, 6, and 12 months after treatment

  2. 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.

    Time frame: 6 and 12 months after treatment

  3. 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.

    Time frame: 6 and 12 months after treatment

07

Study locations

1 site
  • Uşak University Faculty of Dentistry
    Uşak, Uşak, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2024 to primary completion in Mar 2026, 15 months.

Of 66 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's 15 months is close to that.

Counting every sponsor, half of 67 studies reached it within 15 months; a quarter within 9 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2026
First posted
Sep 23, 2026
StartActual
Nov 26, 2024
Primary completionActual
Mar 5, 2026
CompletionActual
Mar 5, 2026
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: identifiers and criteria formatting
1 update, last Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Minor edits only
    + 2 other changes: identifiers and criteria formatting

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07836686
Lead sponsor
Uşak University
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Nov 26, 2024
Primary completion
Mar 5, 2026
Completion
Mar 5, 2026
Last update
Sep 29, 2026

Study contacts

Merve ALKIŞ, DDS
study director · Usak Universty
Merve AKAR, DDS
principal investigator · Usak Universty

Oversight

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

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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