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

Indirect Pulp Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03791255
• Other study ID #: Indirect pulp primary molars
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 2019
• Est. completion date: February 2021

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: February 2021
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deep Carious Lesion
• Dental Caries
• Indirect Pulp Treatment

Intervention

Drug:
• Calcium silicate liner
new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
• Calcium hydroxide liner
Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

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