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Completed

NCT Number: NCT04167943

Conservative Pulp Therapy of Primary Molars Using TheraCAL

The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).

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Key information

Conditions

Reversible Pulpitis

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Dentistry, Ain Shams University

Cairo, 1156, Egypt

About this study

Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Four to six years old healthy children
  • Cooperative (frankle scale + and ++)
  • With at least one vital and restorable primary molar with deep caries.

Exclusion criteria

  • History of spontaneous pain, swelling, or sinus tract
  • Pathological mobility
  • pain on percussion
  • Furcation or periapical radiolucency
  • Internal or external pathological root resorption
  • Widening of periodontal membrane space
  • Discontinuity of lamina dura.

Treatment and study plan

Dual cured resin modified tricalcium silicate cement

Drug

A resin based, dual cured tricalcium silicate based cement

Other names: TheraCal PT

Primary outcomes

  1. Changes in Visual and tactile clinical examination

    Time frame: every 6 months

    Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis

Secondary outcomes

  1. Change in Dental Periapical Radiographic examination

    Time frame: every 6 months

    Teeth will be examined for any radiographic signs of pulp necrosis

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2019
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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