Effect of Different Instrumentation Technique on Endodontic Outcome
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|ClinicalTrials.gov Identifier: NCT03278054|
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Aim: To evaluate and compare the outcome of primary endodontic treatment following use of different instrumentation techniques.
Materials and methods: Study subjects were recruited from the pool of patients referred for the non-surgical root canal treatment in the Department of Conservative Dentistry & Endodontics at PGIDS, Rohtak (Haryana).
The study population comprised of patients requiring primary root canal treatment following the diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first and second molars.
Subjects were allocated to one of the three study groups: manual instrumentation, ProTaper instrumentation and Hybrid instrumentation.
|Condition or disease||Intervention/treatment||Phase|
|Apical Periodontitis||Other: Root Canal Treatment with hand instruments Other: Root canal treatment with Protaper instruments Other: Root canal treatment with hybrid instrumentation||Not Applicable|
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|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Different Instrumentation Technique on Outcome of Primary Non Surgical Endodontic Treatment|
|Actual Study Start Date :||May 1, 2015|
|Actual Primary Completion Date :||November 30, 2015|
|Actual Study Completion Date :||October 30, 2016|
Active Comparator: Manual group
Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files.
Other: Root Canal Treatment with hand instruments
Root canal treatment was performed with K files.
Active Comparator: ProTaper group
Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2.
Other: Root canal treatment with Protaper instruments
Root canals were enlarged with S1 S2 F1F2 F2 Protaper instruments
Active Comparator: Hybrid group
Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files.
Other: Root canal treatment with hybrid instrumentation
Root canal were enlarged with combination of a combination of ProTaper Universal instruments to shape the coronal and middle thirds and Hyflex CM to prepare the apical third
- Radiographic success [ Time Frame: till 12 month period ]Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success
- Clinical success [ Time Frame: 12 months ]Absence of pain tenderness sinus or swelling was graded as clinical success
- Pain intensity [ Time Frame: every 24 hours for 7 days ]Pain intensity before and after treatment was recorded using 0-100 mm VAS scale