Pulp Capping in Primary Molars Using TheraCal (LC)

Deep Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167123
• Other study ID #: FDASU-RECIM041919
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: December 15, 2021

Study information

• Verified date: February 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 15, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

1. Age: 4-7 years.

2. Free medical history.

3. Complete physical and mental health.

4. Patient cooperation

5. restorable mandibular primary molars

Exclusion Criteria:

1. Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain)

2. Soft tissue swelling, draining fistula or sinus tracts.

3. Tenderness to percussion.

4. Pathological Tooth mobility.

5. Widening of periodontal membrane space

Related Conditions & MeSH terms

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

Intervention

Drug:
• Light cured tri-calcium silicate base material
TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe

Locations

Country	Name	City	State
Egypt	Ain Shams University Faculy of Dentistry	Cairo
Egypt	Department of pediatric dentistry - Ain Shams University	Cairo
Egypt	Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	recording pathological Changes in Radiographic examination	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 .	one year follow-up
Secondary	Evaluation of TheraCal (LC) as a pulp capping material	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 .	one year follow-up