Pulp Capping in Primary Molars Using TheraCal (LC)

NCT05167123 | Completed Phase 4

• 1 other identifier: FDASU-RECIM041919
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)).

Conditions

Deep Caries; Indirect Pulp Capping; Direct Pulp Capping; Reversible Pulpitis; Decayed Teeth; Vital Pulp Therapy

Keywords

IPC , DPC

Outcome Measures

Primary Outcomes (1)

• recording signs and symptoms through clinical examination

  All the primary molars participating in this study will be examined clinically under the illumination of dental unit, percussion and palpation test will be performed to ensure absence of any sign and symptoms of irreversible pulpitis or nectrotic pulp during follow -up period.

  one year follow-up

Secondary Outcomes (2)

• recording pathological Changes in Radiographic examination

  one year follow-up

• Evaluation of TheraCal (LC) as a pulp capping material

  one year follow-up

Study Arms (2)

Indirect Pulp Capping

EXPERIMENTAL

TheraCal (LC) will be applied to affected dentin after excavation of infected dentin

Drug: Light cured tri-calcium silicate base material

Direct Pulp Capping

EXPERIMENTAL

TheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin.

Drug: Light cured tri-calcium silicate base material

Interventions

Light cured tri-calcium silicate base material DRUG

TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe

Also known as: TheraCal (LC)

Direct Pulp Capping; Indirect Pulp Capping

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age: 4-7 years.
• Free medical history.
• Complete physical and mental health.
• Patient cooperation
• restorable mandibular primary molars

You may not qualify if:

• Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain)
• Soft tissue swelling, draining fistula or sinus tracts.
• Tenderness to percussion.
• Pathological Tooth mobility.
• Widening of periodontal membrane space

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (3)

Ain Shams University Faculy of Dentistry

Cairo, 02112, Egypt

Location

Department of pediatric dentistry - Ain Shams University

Cairo, 02112, Egypt

Location

Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

TheraCal

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Yomna Hussein Moselhy, M.Sc.

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcome assessor were blinded. The primary investigator blinding was impossible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Simple parallel randomization was performed by using computerized random numbers

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: December 22, 2021
• Study Start: September 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: December 15, 2021
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)