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

Phase 4CompletedNCT06020911

Tanta University17 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulp Caping Biodentine Theracal

Interventions

BiodentineDRUG

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

Theracal light curedDRUG

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, El-garbia, Egypt

Outcomes

Primary Outcomes

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

Time frame: UP to 9 months postoperatively

Radiodenisty in Hounsfield units

Time frame: 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

Time frame: UP to 9 months postoperatively

Data from ClinicalTrials.gov

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