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

T

Tanta University

Status and phase

Completed
Phase 4

Conditions

Pulp Caping
Theracal
Biodentine

Treatments

Drug: Biodentine
Drug: Theracal light cured

Study type

Interventional

Funder types

Other

Identifiers

NCT06020911
R-PED-6-21-6

Details and patient eligibility

About

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

Full 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

Enrollment

17 patients

Sex

All

Ages

4 to 7 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17 participants in 2 patient groups

Biodentine
Active Comparator group
Description:
17 primary second molars of 17 children will be capped with Biodentine.
Treatment:
Drug: Biodentine
Theracal light cured
Active Comparator group
Description:
17 primary second molars of 17 children will be capped with Theracal light cured
Treatment:
Drug: Theracal light cured

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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