Clinical trial NCT06020911: Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars
Official title: Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulp Caping
Biodentine
Theracal
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 17
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Thickness of dentin in mm
timeFrame: UP to 9 months postoperatively
measure: Radiodenisty in Hounsfield units
timeFrame: UP to 9 months postoperatively
measure: pulp vitality
timeFrame: UP to 9 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-garbia
Study officials:
References: