NCT05733468

Brief Summary

To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molar in 9-14 year children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

July 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

February 8, 2023

Last Update Submit

February 16, 2023

Conditions

Irreversible PulpitisDeep Caries

Keywords

MTATheracal LCMature permanent molarscomplete /coronal pulpotomyVital Pulp Therapy

Outcome Measures

Primary Outcomes (2)

  • Clinical success rate

    Clinical success criteria : 1. No history of spontaneous pain or discomfort except for the first day after treatment 2. No tenderness to palpation or percussion and the tooth is functional 3. Normal mobility and probing pocket depth 4. Soft tissues around the tooth are normal with no swelling or sinus tract

    Baseline to 12 months

  • Radiographic success rate

    Radiographic success criteria: 1. No pathosis evident on the radiograph such as root resorption, new furcal or periapical pathosis 2. No canal obliteration

    Baseline to 12 months

Secondary Outcomes (2)

  • Pain assessment

    Baseline to 7 days

  • Hemostasis duration

    Baseline to 12 months

Study Arms (2)

Theracal LC Pulpotomy

EXPERIMENTAL

36 children with the cariously exposed mature permanent molar teeth indicated for pulpotomy and fulfilling the inclusion criteria will be taken for the study and coronal pulpotomy will be done till the level of root canal orifice.

Drug: Theracal LC

MTA Pulpotomy

ACTIVE COMPARATOR

36 children with the cariously exposed mature permanent molar teeth indicated for pulpotomy and fulfilling the inclusion criteria will be taken for the study and coronal pulpotomy will be done till the level of root canal orifice.

Drug: MTA

Interventions

Theracal LCDRUG

After hemorrhage control , 1-1.5mm of TheraCal LC will be placed on the radicular pulp stumps followed by light curing, followed by the placement of IRM and composite restorative material after 2 weeks

Also known as: Resin-modified calcium silicate
Theracal LC Pulpotomy
MTADRUG

After hemorrhage control , a small ball like consistency of 2-3mm of MTA will be placed on the radicular pulp stumps, followed by the placement of IRM and composite restorative material after 2 weeks

Also known as: Bioactive calcium silicate
MTA Pulpotomy

Eligibility Criteria

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

You may qualify if:

  • Patient should be between 9-14 years of age
  • Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain
  • Permanent molar tooth with deep caries and subsequent pulp bleeding evident upon excavation of caries.
  • Rapid exposure to dramatic temperature changes elicited heightened and prolonged episodes of pain even after the thermal stimulus has been removed
  • Vital bleeding pulp tissue should be present in all canals after complete pulpotomy
  • Diagnosis should be irreversible pulpitis.
  • The tooth is restorable and free from advanced periodontal disease
  • Soft tissues around the tooth are normal with no swelling or sinus tract
  • Haemostasis should be achieved after complete pulpotomy
  • The patient has non-contributory medical history

You may not qualify if:

  • Teeth with immature roots
  • Non-restorable
  • Pathological mobility
  • Pus discharge through an associated sinus tract
  • Swelling of associated tissues
  • Radiographic internal or external resorption or with any periapical rarefaction
  • Necrotic pulp upon exposure.
  • Bleeding beyond 25 minutes
  • Children with severe systemic illness (mental retardation/ severe psychotic disorders), prior history of allergy and any medical condition not permitting the intervention.
  • Parents and patients unwilling for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

POST GRADUATE INSTITUTE OF DENTAL SCIENCES Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Vignesh R, MDS

    POST GRADUATE INSTITUTE OF DENTAL SCIENCES Rohtak,Haryana, India- 124001

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

July 1, 2022

Primary Completion

March 1, 2024

Study Completion

May 30, 2024

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)