Effect of Various Sealers on Healing of Teeth With Apical Periodontitis
Primary Purpose
Apical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Zinc oxide based sealer
Epoxy resin based sealer
Bioactive silicone based sealer
Sponsored by
About this trial
This is an interventional treatment trial for Apical Periodontitis
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria of the study will include:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Post Graduate Institute of Dental Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Zinc oxide based sealer
Epoxy resin based sealer
Bioactive silicone based sealer
Arm Description
After root canal treatment obturation with gutta percha will be done using zinc oxide based sealer.
After root canal treatment obturation with gutta percha will be done using epoxy resin based sealer.
After root canal treatment obturation with gutta percha will be done using bioactive silicone based sealer.
Outcomes
Primary Outcome Measures
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.
Clinical success
Absence of pain, sinus tract, swelling and mobility.
Secondary Outcome Measures
Full Information
NCT ID
NCT03397875
First Posted
December 31, 2017
Last Updated
October 14, 2018
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT03397875
Brief Title
Effect of Various Sealers on Healing of Teeth With Apical Periodontitis
Official Title
Effect of Various Sealers on Healing of Teeth With Apical Periodontitis: A Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will compare the effect of three different sealers on healing of teeth with apical periodontitis after primary root canal treatment.
Detailed Description
Various sealers with different chemical composition and properties are available but it is yet not clear if one sealer is superior to other in terms of healing of apical periodontitis.
Three different groups of sealers will be used- a zinc oxide based sealer, an epoxy resin based sealer and a bioactive silicone based sealer. Mature mandibular permanent molar with the diagnosis of apical periodontitis (as confirmed clinically & by periapical radiograph) will be chosen for the study. Primary non surgical root canal treatment will be performed. The sealer will be randomly selected just before obturation of root canals. The patient will be allotted to one of the three groups.
Group I: Zinc oxide eugenol sealer group. The material will be mixed according to manufacturer instructions and applied to canals using a lentulospiral and the obturation will be performed.
Group II: Epoxy resin based sealer group. The material will be mixed according to the manufacturer's instructions and obturation will be done.
Group III: Bioactive silicone based sealer: The material will be used according to the manufacturer's instruction and obturation will be performed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zinc oxide based sealer
Arm Type
Active Comparator
Arm Description
After root canal treatment obturation with gutta percha will be done using zinc oxide based sealer.
Arm Title
Epoxy resin based sealer
Arm Type
Experimental
Arm Description
After root canal treatment obturation with gutta percha will be done using epoxy resin based sealer.
Arm Title
Bioactive silicone based sealer
Arm Type
Experimental
Arm Description
After root canal treatment obturation with gutta percha will be done using bioactive silicone based sealer.
Intervention Type
Procedure
Intervention Name(s)
Zinc oxide based sealer
Intervention Description
After root canal treatment obturation will be done using zinc oxide eugenol based sealer.
Intervention Type
Procedure
Intervention Name(s)
Epoxy resin based sealer
Intervention Description
After root canal treatment obturation will be done using epoxy resin based sealer.
Intervention Type
Procedure
Intervention Name(s)
Bioactive silicone based sealer
Other Intervention Name(s)
After root canal treatment obturation will be done using bioactive silicone based sealer.
Primary Outcome Measure Information:
Title
Radiographic success
Description
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.
Time Frame
12 months
Title
Clinical success
Description
Absence of pain, sinus tract, swelling and mobility.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria of the study will include:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Various Sealers on Healing of Teeth With Apical Periodontitis
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