Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars

Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars

this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials used for the indirect pulp capping

Study Overview

• Status: Not yet recruiting
• Conditions: Pulp Caping; Biodentine; Theracal
• Intervention / Treatment: Drug: Biodentine; Drug: Theracal light cured

Detailed Description

Many materials have been used in indirect pulp capping for primary dentition. An ideal pulp capping material is to be successful when it is biocompatible, radiopaque, maintain good seal, protect the pulp against bacterial invasion in both long and short run, release sustained amounts of calcium ions, act as reservoir for calcium hydroxide and stimulate reparative dentin formation through inducing the pulp cells to form odontoblasts.

Theracal light cured is a light-cured resin modified calcium silicate (RMCS) used as an indirect pulp capping material. It releases more calcium ions than Mineral trioxide aggregate or dycal inducing reparative dentin and dentin bridge formation.Theracal light cured showed better sealing ability and less microleakage than Mineral trioxide aggregate and Biodentine

• Study Type: Interventional
• Enrollment (Estimated): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • El-garbia
    • Tanta, El-garbia, Egypt, 139
      • Tanta University
      • Contact: Alaa A Abd Elghany, MBBCh; Phone Number: 139 002 01551100960; Email: Pearlagh@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Each child has bilateral vital cavitated carious lesions in primary molars.
2. Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed.
3. Patient and parent cooperation.
4. Accessible isolation for the operated tooth with rubber dam.
5. primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin .
6. Availability of remaining dentin thickness over the pulp.
7. Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption.

Exclusion Criteria:

1. Spontaneous pain, or persistent swelling or fistula.
2. Pain with percussion, presence of abscess and pathological mobility.
3. Uncooperative patient.
4. Progression of caries lesion to pulp and pulp exposure.
5. Presence of periapical lesion as abscess, cyst or granuloma.
6. Unhealthy bony tissues.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biodentine; 17 primary second molars of 17 children will be capped with Biodentine.	Drug: Biodentine; 17 primary second molars of 17 children will be capped with Biodentine
Active Comparator: Theracal light cured; 17 primary second molars of 17 children will be capped with Theracal light cured	Drug: Theracal light cured; 17 primary second molars of 17 children will be capped with Theracal light cured

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of dentin in mm	Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Thickness of dentin in mm	UP to 9 months postoperatively
Radiodenisty in Hounsfield units	Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Radiodenisty in Hounsfield units	UP to 9 months postoperatively
pulp vitality	The teeth in each group will be examined clinically after restoration and at the end of the follow up period using vitality tests. Treatment is considered to be successful when pulp remains vital with no signs of pain, no evidence of tooth mobility, normal tooth color, normal gingival health and presence of the restoration intact	UP to 9 months postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 26, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 26, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R-PED-6-21-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: after the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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