Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Calcium Hydroxide for Deep Caries
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal according to the capping material (A),where (A1)represents calcium silicate group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group (A1) in deep occlusal caries and taking the base line image after restoring the cavity with composite restoration and apply light activated calcium hydroxide for(A2)group in deep occlusal caries and taking the base line image after restoring with composite restoration.Take follow up image after one year to measure the calcific bridge formation for both groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
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
July 25, 2017
CompletedFirst Posted
Study publicly available on registry
July 31, 2017
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 20, 2018
July 1, 2017
5 months
July 25, 2017
July 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
calcific bridge formation will be measured by digora software
in millimeters
1 year
Study Arms (2)
light activated calcium silicate
EXPERIMENTALApply light activated calcium silicate in deep occlusal caries lesions and taking the base line image for the first group after restoring the cavity with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.
light activated calcium hydroxide
ACTIVE COMPARATORApply the light activated calcium hydroxide in deep occlusal carious lesions and taking the base line image for the second group after restoring with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.
Interventions
for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration. for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration.
Eligibility Criteria
You may qualify if:
- Normal adults will be recruited in this study ,all the volunteers participated in this experiment will be healthy looking free medical history.
- Patients have simple deep carious lesions in his /her mouth with no pain or history of sensitivity to cold which disappear immediately after removal of the stimulus.
You may not qualify if:
- Medically compromised patients and teeth with history of spontaneous pain or tenderness to percussion were excluded from the study.
- Pregnant females will be excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (1)
Grewal N, Salhan R, Kaur N, Patel HB. Comparative evaluation of calcium silicate-based dentin substitute (Biodentine(R)) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth: Triple blind, randomized clinical trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):457-463. doi: 10.4103/0976-237X.194116.
PMID: 27994411RESULT
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The patient and the outcome assessor will be blinded in this study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident of conservative department ,faculty of oral and dental medicine
Study Record Dates
First Submitted
July 25, 2017
First Posted
July 31, 2017
Study Start
July 1, 2018
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
July 20, 2018
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share