Effect of Various Sealers on Healing of Teeth With Apical Periodontitis
1 other identifier
interventional
99
1 country
1
Brief Summary
This study will compare the effect of three different sealers on healing of teeth with apical periodontitis after primary root canal treatment.
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 Nov 2016
1 active site
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
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 31, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedOctober 17, 2018
April 1, 2018
1.4 years
December 31, 2017
October 14, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Radiographic success
Change in apical bone density will be measured by Periapical Index (PAI) score. PAI score equal to or less than 2 will be categorized as success.
12 months
Clinical success
Absence of pain, sinus tract, swelling and mobility.
12 months
Study Arms (3)
Zinc oxide based sealer
ACTIVE COMPARATORAfter root canal treatment obturation with gutta percha will be done using zinc oxide based sealer.
Epoxy resin based sealer
EXPERIMENTALAfter root canal treatment obturation with gutta percha will be done using epoxy resin based sealer.
Bioactive silicone based sealer
EXPERIMENTALAfter root canal treatment obturation with gutta percha will be done using bioactive silicone based sealer.
Interventions
After root canal treatment obturation will be done using zinc oxide eugenol based sealer.
After root canal treatment obturation will be done using epoxy resin based sealer.
Eligibility Criteria
You may qualify if:
- Patient willing to participate in the study.
- Age \>18 years.
- No history of antibiotic use within the past month or requiring antibiotic premedication
- No history of prior analgesic use during past 24 hrs.
- Mature permanent mandibular molar having apical periodontitis requiring primary root canal treatment.
- There must be a radiographic evidence of periapical radiolucency (minimum size 2mmx2mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
You may not qualify if:
- Re-treatment
- Unwillingness of patients
- The presence of a difficult canal anatomy (root canals with an extreme curvature ≥30 deg), internal or external resorption and immature teeth.
- Accident or complication during treatment (calcified canals ,inability to achieve apical patency in any canals) Immuno-compromised, diabetic, pregnant and hypertensive patients.
- Teeth that are peridontally compromised
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Interventions
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
December 31, 2017
First Posted
January 12, 2018
Study Start
November 1, 2016
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
October 17, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share