Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.

Study Overview

• Status: Unknown
• Conditions: Indirect Pulp Treatment; Deep Carious Lesion
• Intervention / Treatment: Drug: Calcium silicate liner; Drug: Calcium hydroxide liner

Detailed Description

To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars.

P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment.

I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal).

C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Medically free children.
2. Age range from 4-7 years.
3. Presence of lower second primary molars with deep carious occlusal lesion.
4. No history of spontaneous pain (reversible pulpitis).
5. Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility.
6. Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption.

Exclusion Criteria:

1. Uncooperative children.
2. Any unmet previous criterion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resin Modified Calcium Silicate; light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping	Drug: Calcium silicate liner; new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
Active Comparator: Light Cured Calcium Hydroxide; gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.	Drug: Calcium hydroxide liner; Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Pain questionnaire (binary yes/no)	1 month
Postoperative pain	Pain questionnaire (binary yes/no)	3 months
Postoperative pain	Pain questionnaire (binary yes/no)	6 months
Postoperative pain	Pain questionnaire (binary yes/no)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swelling	Visual examination by the operator (binary yes/no)	1 month
Swelling	Visual examination by the operator (binary yes/no)	3 months
Swelling	Visual examination by the operator (binary yes/no)	6 months
Swelling	Visual examination by the operator (binary yes/no)	12 months
Sinus or fistula	Visual examination by the operator (binary yes/no)	1 month
Sinus or fistula	Visual examination by the operator (binary yes/no)	3 months
Sinus or fistula	Visual examination by the operator (binary yes/no)	6 months
Sinus or fistula	Visual examination by the operator (binary yes/no)	12 months
Tooth mobility	back of the mirror to check mobility (binary yes/no)	1 month
Tooth mobility	back of the mirror to check mobility (binary yes/no)	3 months
Tooth mobility	back of the mirror to check mobility (binary yes/no)	6 months
Tooth mobility	back of the mirror to check mobility (binary yes/no)	12 months
pain on percussion	back of the mirror to check pain on percussion (binary yes/no)	1 month
pain on percussion	back of the mirror to check pain on percussion (binary yes/no)	3 months
pain on percussion	back of the mirror to check pain on percussion (binary yes/no)	6 months
pain on percussion	back of the mirror to check pain on percussion (binary yes/no)	12 months
Occurrence of radiolucent lesions at furcation or periapical region	(binary yes/no)	1 months
Occurrence of radiolucent lesions at furcation or periapical region	(binary yes/no)	3 months
Occurrence of radiolucent lesions at furcation or periapical region	(binary yes/no)	6 months
Occurrence of radiolucent lesions at furcation or periapical region	(binary yes/no)	12 months
widening in the periodontal membrane space	(binary yes/no)	1 month
widening in the periodontal membrane space	(binary yes/no)	3 months
widening in the periodontal membrane space	(binary yes/no)	6 months
widening in the periodontal membrane space	(binary yes/no)	12 months
presence of internal or external root resorption	(binary yes/no)	1 month
presence of internal or external root resorption	(binary yes/no)	3 months
presence of internal or external root resorption	(binary yes/no)	6 months
presence of internal or external root resorption	(binary yes/no)	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 29, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: indirect pulp treatment; primary molars; resin modified calcium silicate
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium; Calcium, Dietary
• Other Study ID Numbers: Indirect pulp primary molars

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No