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Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

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ClinicalTrials.gov Identifier: NCT03791255
Recruitment Status : Unknown
Verified January 2019 by Yasmine Ashraf Elbanna, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 2, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Yasmine Ashraf Elbanna, Cairo University

Study Description
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Brief Summary:
The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.

Condition or disease Intervention/treatment Phase
Deep Carious Lesion Indirect Pulp Treatment Drug: Calcium silicate liner Drug: Calcium hydroxide liner Phase 4

Detailed Description:

To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars.

P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment.

I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal).

C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Resin Modified Calcium Silicate
light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
 Drug: Calcium silicate liner
new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
Active Comparator: Light Cured Calcium Hydroxide
gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.
 Drug: Calcium hydroxide liner
Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 1 month ]
    Pain questionnaire (binary yes/no)

  2. Postoperative pain [ Time Frame: 3 months ]
    Pain questionnaire (binary yes/no)

  3. Postoperative pain [ Time Frame: 6 months ]
    Pain questionnaire (binary yes/no)

  4. Postoperative pain [ Time Frame: 12 months ]
    Pain questionnaire (binary yes/no)


Secondary Outcome Measures :
  1. Swelling [ Time Frame: 1 month ]
    Visual examination by the operator (binary yes/no)

  2. Swelling [ Time Frame: 3 months ]
    Visual examination by the operator (binary yes/no)

  3. Swelling [ Time Frame: 6 months ]
    Visual examination by the operator (binary yes/no)

  4. Swelling [ Time Frame: 12 months ]
    Visual examination by the operator (binary yes/no)

  5. Sinus or fistula [ Time Frame: 1 month ]
    Visual examination by the operator (binary yes/no)

  6. Sinus or fistula [ Time Frame: 3 months ]
    Visual examination by the operator (binary yes/no)

  7. Sinus or fistula [ Time Frame: 6 months ]
    Visual examination by the operator (binary yes/no)

  8. Sinus or fistula [ Time Frame: 12 months ]
    Visual examination by the operator (binary yes/no)

  9. Tooth mobility [ Time Frame: 1 month ]
    back of the mirror to check mobility (binary yes/no)

  10. Tooth mobility [ Time Frame: 3 months ]
    back of the mirror to check mobility (binary yes/no)

  11. Tooth mobility [ Time Frame: 6 months ]
    back of the mirror to check mobility (binary yes/no)

  12. Tooth mobility [ Time Frame: 12 months ]
    back of the mirror to check mobility (binary yes/no)

  13. pain on percussion [ Time Frame: 1 month ]
    back of the mirror to check pain on percussion (binary yes/no)

  14. pain on percussion [ Time Frame: 3 months ]
    back of the mirror to check pain on percussion (binary yes/no)

  15. pain on percussion [ Time Frame: 6 months ]
    back of the mirror to check pain on percussion (binary yes/no)

  16. pain on percussion [ Time Frame: 12 months ]
    back of the mirror to check pain on percussion (binary yes/no)

  17. Occurrence of radiolucent lesions at furcation or periapical region [ Time Frame: 1 months ]
    (binary yes/no)

  18. Occurrence of radiolucent lesions at furcation or periapical region [ Time Frame: 3 months ]
    (binary yes/no)

  19. Occurrence of radiolucent lesions at furcation or periapical region [ Time Frame: 6 months ]
    (binary yes/no)

  20. Occurrence of radiolucent lesions at furcation or periapical region [ Time Frame: 12 months ]
    (binary yes/no)

  21. widening in the periodontal membrane space [ Time Frame: 1 month ]
    (binary yes/no)

  22. widening in the periodontal membrane space [ Time Frame: 3 months ]
    (binary yes/no)

  23. widening in the periodontal membrane space [ Time Frame: 6 months ]
    (binary yes/no)

  24. widening in the periodontal membrane space [ Time Frame: 12 months ]
    (binary yes/no)

  25. presence of internal or external root resorption [ Time Frame: 1 month ]
    (binary yes/no)

  26. presence of internal or external root resorption [ Time Frame: 3 months ]
    (binary yes/no)

  27. presence of internal or external root resorption [ Time Frame: 6 months ]
    (binary yes/no)

  28. presence of internal or external root resorption [ Time Frame: 12 months ]
    (binary yes/no)


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Medically free children.
  2. Age range from 4-7 years.
  3. Presence of lower second primary molars with deep carious occlusal lesion.
  4. No history of spontaneous pain (reversible pulpitis).
  5. Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility.
  6. Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption.

Exclusion Criteria:

  1. Uncooperative children.
  2. Any unmet previous criterion.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yasmine Ashraf Elbanna, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03791255    
Other Study ID Numbers: Indirect pulp primary molars
First Posted: January 2, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasmine Ashraf Elbanna, Cairo University:
resin modified calcium silicate
indirect pulp treatment
primary molars
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
 Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents