ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Different Instrumentation Technique on Endodontic Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03278054
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

Brief Summary:

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. Clinical success [ Time Frame: 12 months ]
    Absence of pain tenderness sinus or swelling was graded as clinical success


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: every 24 hours for 7 days ]
    Pain intensity before and after treatment was recorded using 0-100 mm VAS scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient willing to participate in the study.
  • Age greater than 18 years.
  • No history of antibiotic use prior to treatment.
  • Mature permanent mandibular molar having apical periodontitis requiring primary root canal treatment.
  • There must be a radiographic evidence of periapical radiolucency 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:

  • Root canal retreatment.
  • Failure to obtain authorization from patients.
  • The presence of a difficult canal anatomy, internal or external resorption and immature teeth.
  • Accident or complication during treatment like calcified canals, inability to achieve apical patency in any canals.
  • Immuno-compromised, diabetic, pregnant and hypertensive patients.
  • Periodontally compromised teeth.

Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT03278054     History of Changes
Other Study ID Numbers: seema
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Postgraduate Institute of Dental Sciences Rohtak:
apical periodontitis
hybrid
ProTaper
rotary

Additional relevant MeSH terms:
Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases