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Effect of Different Instrumentation Technique on Endodontic Outcome

Primary Purpose

Apical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root Canal Treatment with hand instruments
Root canal treatment with Protaper instruments
Root canal treatment with hybrid instrumentation
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring apical periodontitis, hybrid, ProTaper, rotary

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Manual group

    ProTaper group

    Hybrid group

    Arm Description

    Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files.

    Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2.

    Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files.

    Outcomes

    Primary Outcome Measures

    Radiographic success
    Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success
    Clinical success
    Absence of pain tenderness sinus or swelling was graded as clinical success

    Secondary Outcome Measures

    Pain intensity
    Pain intensity before and after treatment was recorded using 0-100 mm VAS scale

    Full Information

    First Posted
    June 26, 2017
    Last Updated
    September 8, 2017
    Sponsor
    Postgraduate Institute of Dental Sciences Rohtak
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03278054
    Brief Title
    Effect of Different Instrumentation Technique on Endodontic Outcome
    Official Title
    Effect of Different Instrumentation Technique on Outcome of Primary Non Surgical Endodontic Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2015 (Actual)
    Primary Completion Date
    November 30, 2015 (Actual)
    Study Completion Date
    October 30, 2016 (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
    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.
    Detailed Description
    AIMS AND OBJECTIVES The present study has been designed with the following aims and objective: To evaluate the effect of manual / rotary/hybrid instrumentation techniques on success of primary non surgical root canal treatment in teeth with apical periodontitis. To assess the incidence of postoperative pain in teeth treated with and without rotary instrumentation. To compare manual, rotary and hybrid instrumentation techniques in terms of periapical healing in teeth with apical periodontitis. METHODOLOGY Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient. Prior informed consent was taken after explaining the procedure, risks and benefits. Clinical procedure: A total of 90 patients (n=30 in each group) were included in the study. Mature mandibular permanent molar with diagnosis of apical periodontitis (as confirmed clinically & by periapical radiograph) were chosen for the study. Patients were randomly allocated into three groups :Group I- manual instrumentation, Group II -rotary instrumentation (ProTaper) and Group III -Rotary instrumentation (Hybrid ). After administration of local anesthesia, rubber dam isolation of the involved tooth was done. Caries excavation was done and access cavity was prepared using carbide burs in high speed handpiece with copious irrigation.Debridement of the pulp chamber was done and all canal orifices were identified. Negotiation of canals was done. Working length was determined using root ZX apex locator and verified radiographically. Instrumentation was done as follows. GROUP A: Manual instrumentation: Hand instrumentation with the stainless steel K files was performed using step back technique. GROUP B: Rotary instrumentation (ProTaper files): The cleaning and shaping of the canals was completed in accordance with a crown down technique recommended by the manufacturer, using the following operative sequence. Canals were instrumented with ProTaper rotary instruments. Recapitulation was carried out with size 10 k file. GROUP C: rotary instrumentation (Hybrid): Roots canals were shaped with a combination of two NiTi rotary systems: ProTaper Universal instruments were used to shape the coronal and middle thirds and Hyflex CM files to prepare the apical third. After completion of canal instrumentation in all the groups, canals were irrigated with 5.0 mL of 17% ethylene-diamine-tetra acetic acid for 1 minute followed by a final irrigation with 5.0 mL of 5.25% sodium hypochlorite. Canals were then be dried with sterile paper points. A lentulo-spiral was used to fill all canals with a Calcium hydroxide paste and the access cavity to be restored with intermediate restorative material. The patient were recalled after 1 week. At the second appointment, the calcium hydroxide paste were removed by using circumferential filing with Hedstrom files and copious irrigation with 5.25% sodium hypochlorite followed by 5.0 mL of 17% ethylenediaminetetraacetic acid and a final rinse of 5.0 mL 5.25% sodium hypochlorite. Canals were dried with the help of absorbent paper points and obturated. After obturation, the cavity was permanently restored. Immediate post-operative radiograph was then taken using preset exposure parameters and processed manually. FOLLOW UP Follow up and clinical and radiographic examination was carried out at 3, 6, 9 & 12 month period. Outcome variables The primary outcome variables observed for the study was long term clinical and radiographic success rates. The secondary outcome measure was the incidence of postoperative pain. Radiographic success: Radiographic success (change in Periapical Index score) of the root canal therapy was drawn by comparing the pre-operative; 3 month, 6month, 9 month & 12-month follow up radiographs. Clinical success: it was determined by Absence of inter appointment flare ups and pain. Absence of tenderness to palpation /percussion Absence of sinus or any associated soft tissue swelling. Tooth mobility of grade I or less. No deterioration in periodontal pocket depth.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Apical Periodontitis
    Keywords
    apical periodontitis, hybrid, ProTaper, rotary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Manual group
    Arm Type
    Active Comparator
    Arm Description
    Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files.
    Arm Title
    ProTaper group
    Arm Type
    Active Comparator
    Arm Description
    Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2.
    Arm Title
    Hybrid group
    Arm Type
    Active Comparator
    Arm Description
    Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files.
    Intervention Type
    Other
    Intervention Name(s)
    Root Canal Treatment with hand instruments
    Intervention Description
    Root canal treatment was performed with K files.
    Intervention Type
    Other
    Intervention Name(s)
    Root canal treatment with Protaper instruments
    Intervention Description
    Root canals were enlarged with S1 S2 F1F2 F2 Protaper instruments
    Intervention Type
    Other
    Intervention Name(s)
    Root canal treatment with hybrid instrumentation
    Intervention Description
    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 Measure Information:
    Title
    Radiographic success
    Description
    Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success
    Time Frame
    till 12 month period
    Title
    Clinical success
    Description
    Absence of pain tenderness sinus or swelling was graded as clinical success
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Pain intensity before and after treatment was recorded using 0-100 mm VAS scale
    Time Frame
    every 24 hours for 7 days

    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: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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