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NCT Number: NCT05167123

Pulp Capping in Primary Molars Using TheraCal (LC)

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)).

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Key information

Conditions

Deep Caries Decayed Teeth Dental Caries Direct Pulp Capping Indirect Pulp Capping Reversible Pulpitis Stomatognathic Diseases Tooth Demineralization Tooth Diseases Vital Pulp Therapy

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Faculy of Dentistry, Cairo, Egypt

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About this study

Participating primary molars will be randomly allocated to one of the following groups: Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate base material (TheraCal (LC) ) will be used in the two groups as a dressing material. Patients will be recruited from the outpatient clinic of the pediatric dentistry department, Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up assessments at 3, 6,9, and 12 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: TheraCal (LC)

Primary outcomes

  1. recording signs and symptoms through clinical examination

    Time frame: one year follow-up

    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.

Secondary outcomes

  1. recording pathological Changes in Radiographic examination

    Time frame: one year follow-up

    All the primary molars participating in this study will be examined radiographically every (3,6,9,12 months) to ensure the absence of any pathological changes .

  2. Evaluation of TheraCal (LC) as a pulp capping material

    Time frame: one year follow-up

    Clinical and radiographic examination will be done to each tooth participating in this study to evaluate the efficiency of TheraCal (LC) when used as a pulp capping material in primary molars .

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Radiographic and Clinical Evaluation of Indirect and Direct Pulp Capping in Primary Molars Using TheraCal (LC)

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2021
Registry last updated
Feb 3, 2023

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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