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

Phase 4

• Conditions: Deep Carious Lesion; Indirect Pulp Treatment
• Interventions: Drug: Calcium hydroxide liner; Drug: Calcium silicate liner

• Registration Number: NCT03791255
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2018-12-29
• Status Verified: 2019-01
• Study First Posted: 2019-01-02
• Last Update Submitted: 2019-01-12
• Last Update Posted: 2019-01-15
• Study Start: 2019-02
• Primary Completion: 2020-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light Cured Calcium Hydroxide	Calcium hydroxide liner	gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.
Resin Modified Calcium Silicate	Calcium silicate liner	light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping

Primary Outcome Measures

Name	Time	Method
Postoperative pain	12 months	Pain questionnaire (binary yes/no)

Secondary Outcome Measures

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