NCT07046533

Brief Summary

The goal of This current study compare the clinical \& radiographic success rate between two different modalities conventional RCT and VPT using Bio-C-Repair as a pulp capping material to treat young patients with mature first permanent molars with irreversible pulpitis.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2025

Status
not yet recruiting

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

Study Progress85%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

June 13, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 13, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

randomized control trialvital pulp therapy

Outcome Measures

Primary Outcomes (1)

  • success rate

    clinically and radiographically success rate according to success criteria

    12 months

Study Arms (2)

root canal treatment

ACTIVE COMPARATOR

invasive technique depends on removal of all pulp tissue coronal and radicular and restore it with a gutta perch with bioceramic sealer

Procedure: (pulpotomy)Procedure: root canal treatment

pulpotomy

EXPERIMENTAL

non invasive technique depends on removal of only coronal pulp tissue and restore it with a new material bio c repair

Procedure: (pulpotomy)Procedure: root canal treatment

Interventions

(pulpotomy)PROCEDURE

non invasive technique depends on remove only the coronal pulp tissue instead of remove all pulp tissue

Also known as: vital pulp therapy
pulpotomyroot canal treatment

invasive technique depends on remove all radicular and coronal pulp tissue

pulpotomyroot canal treatment

Eligibility Criteria

Age9 Months - 14 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Molars teeth with a history of spontaneous radiating pain indicated IP
  • the pain triggered by hot/cold fluids lasted for several minutes after removing of the stimulus.
  • Molars teeth with no prominent radiolucency at the periapical or furcation regions

You may not qualify if:

  • Teeth with continuous bleeding
  • necrosis
  • Teeth could not be restored with direct restoration. Teeth having localized/generalized periodontal diseases (probing pocket depth more than 3 mm).
  • Teeth with crack fracture. Teeth with internal/external root resorption. Teeth with pulp chamber/canal calcification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ToothacheDental CariesDisease

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DemineralizationPathologic Processes

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Pediatric Dentistry, Faculty of Dentistry October 6th University

Study Record Dates

First Submitted

June 13, 2025

First Posted

July 1, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 1, 2025

Record last verified: 2025-06