Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM
Primary Purpose
Periapical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Nonsurgical Root canal therapy
Dental operating microscope
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Periodontitis focused on measuring Dental Operating Microscope
Eligibility Criteria
Inclusion Criteria:
- Patient willing to participate in the study
- Age > 18 years
- Maxillary permanent first molar having apical periodontitis requiring primary endodontic treatment
- Radiographic evidence of periapical radiolucency (minimum size 2 mmx 2 mm) 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:
- Unwillingness of patient.
- Retreatment cases
- Presence of internal or external resorption ,root canal perforations during endodontic treatment and immature teeth.
- Periodontally compromised teeth
- Immunocompromised, diabetic, pregnant and hypertensive patients
- Vertical root fractures
- Teeth those are not suitable for rubber dam application
Sites / Locations
- Post Graduate Institute of Dental Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Nonsurgical Root canal therapy was performed using dental operating microscope in the experimental group.
Nonsurgical Root canal therapy was performed without any magnification aid in control group.
Outcomes
Primary Outcome Measures
Clinical and radiographic success
long term clinical and radiographic success measured in terms of reduction in size of periapical radiolucency on radiograph from baseline to 12 months using PAI score 1,2 as healing and more than 2 as non healing
Secondary Outcome Measures
Number of canals located in MB root
incidence of additional canals located in MB root
Full Information
NCT ID
NCT04358861
First Posted
April 17, 2020
Last Updated
April 22, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT04358861
Brief Title
Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM
Official Title
Healing Outcome of Nonsurgical Root Canal Treatment in Maxillary Molars With Dental Operating Microscope : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
January 1, 2020 (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
The aim of study was to evaluate the effect of dental operating microscope use on the healing outcome of non surgical endodontic treatment of maxillary molars.
Detailed Description
Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient and written informed consent was taken after explaining the procedure, risks and benefits. Mature maxillary first permanent molar with diagnosis of periapical periodontitis (as confirmed clinically & by periapical radiograph) was chosen for the study. Fifty participants were randomly assigned to either the dental operating microscope group or to control group (without using dental operating microscope) for the treatment.
After administration of local anesthesia and rubber dam isolation of the involved tooth ; access cavity was prepared using carbide bur and refined using ultrasonic tip in both groups. In both the groups similar protocol for irrigation, obturation and post operative restorations was followed. Immediate post-operative radiograph was taken using preset exposure parameters and follow up clinical and radiographic examination was carried at 12th month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
Dental Operating Microscope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Nonsurgical Root canal therapy was performed using dental operating microscope in the experimental group.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Nonsurgical Root canal therapy was performed without any magnification aid in control group.
Intervention Type
Procedure
Intervention Name(s)
Nonsurgical Root canal therapy
Intervention Description
After administration of LA and rubber dam isolation, acess cavity was prepared using carbide burs. Working length was determined using root ZX apex locator and was verified radiographically. Canal preparation was done with protaper gold rotary instruments. 5ml of 5.25% NaOCl was used as irrigant. After instrumentation , the canals were irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals were dried with absorbent paper points, filled with calcium hydroxide paste and access cavity was restored with IRM.At the recall appointment ; after one week,paste removal, copious irrigation was done with 5.25% NaOCl and canals were dried with paper points. Canals were obturated with Gutta-Percha and ZOE based sealer.
Intervention Type
Device
Intervention Name(s)
Dental operating microscope
Intervention Description
Dental operating microscope; a high magnification and illumination device was used in experimental group for performing nonsurgical root canal therapy.
Primary Outcome Measure Information:
Title
Clinical and radiographic success
Description
long term clinical and radiographic success measured in terms of reduction in size of periapical radiolucency on radiograph from baseline to 12 months using PAI score 1,2 as healing and more than 2 as non healing
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of canals located in MB root
Description
incidence of additional canals located in MB root
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient willing to participate in the study
Age > 18 years
Maxillary permanent first molar having apical periodontitis requiring primary endodontic treatment
Radiographic evidence of periapical radiolucency (minimum size 2 mmx 2 mm) 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:
Unwillingness of patient.
Retreatment cases
Presence of internal or external resorption ,root canal perforations during endodontic treatment and immature teeth.
Periodontally compromised teeth
Immunocompromised, diabetic, pregnant and hypertensive patients
Vertical root fractures
Teeth those are not suitable for rubber dam application
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
Undecided
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Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM
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