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

NCT06020911 | Completed Phase 4 DMC

• 1 other identifier: R-PED-6-21-6
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulp Caping; Biodentine; Theracal

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Biodentine

ACTIVE COMPARATOR

17 primary second molars of 17 children will be capped with Biodentine.

Drug: Biodentine

Theracal light cured

ACTIVE COMPARATOR

17 primary second molars of 17 children will be capped with Theracal light cured

Drug: Theracal light cured

Interventions

Biodentine DRUG

17 primary second molars of 17 children will be capped with Biodentine

Biodentine

Theracal light cured DRUG

17 primary second molars of 17 children will be capped with Theracal light cured

Theracal light cured

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Each child has bilateral vital cavitated carious lesions in primary molars.
• 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.
• Patient and parent cooperation.
• Accessible isolation for the operated tooth with rubber dam.
• primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin .
• Availability of remaining dentin thickness over the pulp.
• Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption.

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-garbia, 139, Egypt

Location

MeSH Terms

Interventions

tricalcium silicate

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator Alaa Abd Elhameed Abd Elghany

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 1, 2023
• Study Start: January 30, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)