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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06020911
Enrollment
17
Registered
2023-09-01
Start date
2023-01-30
Completion date
2023-10-01
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biodentine, Pulp Caping, Theracal

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

Interventions

DRUGBiodentine

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

DRUGTheracal light cured

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Thickness of dentin in mmUP to 9 months postoperativelyCone-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
Radiodenisty in Hounsfield unitsUP to 9 months postoperativelyCone-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
pulp vitalityUP to 9 months postoperativelyThe 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026