Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
1 other identifier
interventional
46
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2018
CompletedFirst Posted
Study publicly available on registry
January 2, 2019
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedJanuary 15, 2019
January 1, 2019
1 year
December 27, 2018
January 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Postoperative pain
Pain questionnaire (binary yes/no)
1 month
Postoperative pain
Pain questionnaire (binary yes/no)
3 months
Postoperative pain
Pain questionnaire (binary yes/no)
6 months
Postoperative pain
Pain questionnaire (binary yes/no)
12 months
Secondary Outcomes (28)
Swelling
1 month
Swelling
3 months
Swelling
6 months
Swelling
12 months
Sinus or fistula
1 month
- +23 more secondary outcomes
Study Arms (2)
Resin Modified Calcium Silicate
EXPERIMENTALlight-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
Light Cured Calcium Hydroxide
ACTIVE COMPARATORgold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.
Interventions
new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge
Eligibility Criteria
You may qualify if:
- Medically free children.
- Age range from 4-7 years.
- Presence of lower second primary molars with deep carious occlusal lesion.
- No history of spontaneous pain (reversible pulpitis).
- Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility.
- Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption.
You may not qualify if:
- Uncooperative children.
- Any unmet previous criterion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
December 27, 2018
First Posted
January 2, 2019
Study Start
February 1, 2019
Primary Completion
February 1, 2020
Study Completion
February 1, 2021
Last Updated
January 15, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share