Clinical and Radiographic Evaluation of Deep Occlusal Carious Molars Treated With Partial Caries Removal With and Without Using Silver Diamine Fluoride (SDF) Prior to Resin Composite Restoration.
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The aim of the study is to evaluate the effect of SDF in maintaining pulp health after partial caries removal in permanent teeth with deep occlusal carious lesion clinically and radiographically
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2020
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
September 20, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedDecember 3, 2020
December 1, 2020
Same day
September 20, 2020
December 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
clinical survival
express as a binary variable indicating whether the restored tooth maintained its pulp vitality
12 months
Study Arms (2)
resin modified glassionomer cement
EXPERIMENTALApplication of Resin modified glass ionomer cement (RMGIC) (Fuji Lining LC; GC, Tokyo, Japan) prior resin composite restoration (Filtek Z350 XT,3MESPE)
silver diamine flouride
ACTIVE COMPARATORApplication of 38% SDF (Riva Star, SDI, Bayswater, Australia), and Resin modified glass ionomer cement (RMGIC) (Fuji Lining LC; GC, Tokyo, Japan) prior resin composite restoration (Filtek Z350 XT,3MESPE).
Interventions
Application of 38% SDF (Riva Star, SDI, Bayswater, Australia), and Resin modified glass ionomer cement (RMGIC) (Fuji Lining LC; GC, Tokyo, Japan) prior resin composite restoration (Filtek Z350 XT,3MESPE).
resin modified glassionomer cement
Eligibility Criteria
You may qualify if:
- Class I carious lesions.
- Lower and upper molars.
- years.
- Not received antibiotic therapy since 1 month before sampling.
- Males or Females (Both genders).
- Co-operative patients approving the trial
You may not qualify if:
- known allergic reaction to fluoride or silver
- Systemic disease or severe medical complications.
- Periodontal problem.
- Mobile teeth, arrest caries and non-vital teeth
- Ulcerative gingivitis, and Stomatitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The operator cannot be blinded because of the difference in operative and application procedures between control and intervention groups. The operator will blind until randomization into groups to avoid bias regarding the application of SDF to which tooth. However, the patients and assessors who carried out the radiographic assessment will be blinded of the treatment group. Finally, the treatment results will assess blindly by a statistician
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
September 20, 2020
First Posted
September 24, 2020
Study Start
December 1, 2020
Primary Completion
December 1, 2020
Study Completion
November 1, 2021
Last Updated
December 3, 2020
Record last verified: 2020-12