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Completed

NCT Number: NCT06020911

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

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University

Tanta, El-garbia, 139, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Biodentine

Drug

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

Theracal light cured

Drug

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

Primary outcomes

  1. Thickness of dentin in mm

    Time frame: UP to 9 months postoperatively

    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

  2. Radiodenisty in Hounsfield units

    Time frame: UP to 9 months postoperatively

    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

  3. pulp vitality

    Time frame: UP to 9 months postoperatively

    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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2023
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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