NCT05336682

Brief Summary

Group I (Experimental group I): Lesion Sterilization and Tissue Repair with radicular instrumentation. Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals. Group II (Experimental group II): Lesion Sterilization and Tissue Repair with no radicular instrumentation. Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix. Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

April 7, 2022

Last Update Submit

February 25, 2026

Conditions

Pulpitis - Irreversible

Keywords

LSTRLesion Sterilization and Tissue Repairpulpectomyzinc oxide and eugenolirreversible pulpitisvitalprimary molars

Outcome Measures

Primary Outcomes (2)

  • Clinical success "binary"

    Absence of • Spontaneous pain. * Sensitivity to percussion using dental mirror, pain on biting. * Swelling. * Fistula / Exudate. * Mobility.

    12 months

  • Radiographic success "binary"

    Absence of • Absence of furcation or periapical radiolucency. • Absence of change in the extent of internal or external root resorption other than physiologic resorption.

    12 months

Secondary Outcomes (3)

  • Child cooperation

    Immediately after the intervention

  • Parental satisfaction

    Immediately after the intervention

  • Chair side time

    Immediately after the intervention

Study Arms (3)

LSTR with radicular instrumentation.

EXPERIMENTAL
Procedure: Lesion Sterilization and Tissue Repair with radicular instrumentation

LSTR with no radicular instrumentation.

EXPERIMENTAL
Procedure: Lesion Sterilization and Tissue Repair without radicular instrumentation

Conventional pulpectomy.

ACTIVE COMPARATOR
Procedure: Conventional pulpectomy

Interventions

Lesion Sterilization and Tissue Repair with radicular instrumentationPROCEDURE

Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and the canals.

LSTR with radicular instrumentation.
Lesion Sterilization and Tissue Repair without radicular instrumentationPROCEDURE

Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix.

LSTR with no radicular instrumentation.
Conventional pulpectomyPROCEDURE

Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of ZOE.

Conventional pulpectomy.

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Molars should be restorable.
  • Mandibular second primary molars with deep caries, vital carious pulp exposure, irreversible pulpitis.
  • Mobility: Non or grade I.
  • Radiographic signs of minimal external root resorption.

You may not qualify if:

  • Children with known allergy to the agents used.
  • Children with infective endocarditis.
  • Refusal of participation.
  • Unable to attend follow-up visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Wound Healing

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Gihan M Abuelniel, Professor

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Pediatric Dentistry

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 20, 2022

Study Start

September 20, 2022

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

EG(1)