Effect of Intraorifice Barrier on Healing of Apical Periodontitis
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
Based on various in-vitro studies intraorifice barrier has been suggested as an effective mean to provide seal against coronal microleakage. This study intends to clinically investigate efficacy of intraorifice barrier in healing of apical periodontitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
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
Study Start
First participant enrolled
October 14, 2016
CompletedFirst Submitted
Initial submission to the registry
January 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedMay 23, 2018
January 1, 2018
1.3 years
January 18, 2018
May 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical success
Success was defined as absence of signs and symptoms
Baseline to one year
Secondary Outcomes (1)
Radiographic Success
Baseline to one year
Study Arms (3)
Intraorifice Group
EXPERIMENTALIntraorifice barrier of GIC.
Base Group
EXPERIMENTALBase of GIC
Control Group
ACTIVE COMPARATORDirect composite restoration
Interventions
After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.
After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.
After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.
Eligibility Criteria
You may qualify if:
- Mature permanent mandibular molars.
- Pulpal necrosis as confirmed by negative response to pulp sensibility test (cold and electric pulp test) ;
- Radiographic evidence of apical periodontitis in the form of periapical radiolucency (size not more than 2 × 2mm);
You may not qualify if:
- Younger than 18 years;
- Pregnant, diabetic, or immunocompromised;
- Having a positive history of antibiotic use within the past month or require antibiotic premedication for dent treatment (including infective endocarditis or prosthetic joint prophylaxis);
- Teeth having previous root fillings, unrestorable teeth, fractured/perforated roots, grade 3 mobility, and his of recent periodontal therapy (within previous 6 months);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2018
First Posted
January 24, 2018
Study Start
October 14, 2016
Primary Completion
January 31, 2018
Study Completion
January 31, 2018
Last Updated
May 23, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share