Pulp Capping in Primary Molars Using TheraCal (LC)

Phase 4

Completed

• Conditions: Deep Caries; Indirect Pulp Capping; Direct Pulp Capping; Reversible Pulpitis; Decayed Teeth; Vital Pulp Therapy
• Interventions: Drug: Light cured tri-calcium silicate base material

• Registration Number: NCT05167123
• Lead Sponsor: Ain Shams University

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)).

Detailed 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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2021-09-28
• Primary Completion: 2021-11-30
• Study First Submitted QC: 2021-12-07
• Study Completion: 2021-12-15
• Study First Posted: 2021-12-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indirect Pulp Capping	Light cured tri-calcium silicate base material	TheraCal (LC) will be applied to affected dentin after excavation of infected dentin
Direct Pulp Capping	Light cured tri-calcium silicate base material	TheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin.

Primary Outcome Measures

Name	Time	Method
recording signs and symptoms through clinical examination	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 Outcome Measures

Name	Time	Method
recording pathological Changes in Radiographic examination	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 .
Evaluation of TheraCal (LC) as a pulp capping material	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 .

Trial Locations

Locations (3)

Department of pediatric dentistry - Ain Shams University; 🇪🇬 Cairo, Egypt

Ain Shams University Faculy of Dentistry; 🇪🇬 Cairo, Egypt

Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University; 🇪🇬 Cairo, Egypt