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Effect of Apical Patency on Success of Root Canal Treatment in Non Vital Teeth

Primary Purpose

Apical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Apical patency
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 Patency, Root Canal Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Mature permanent mandibular first molars
  2. Diagnosis of pulp necrosis, as confirmed by negative response to cold and electrical tests
  3. Radiographic evidence of apical periodontitis (minimum size ≥ 2.0 × 2.0 mm)
  4. Probing depth < 4mm

Exclusion Criteria:

  1. Non willingness to participate in study
  2. younger than 18 years of age
  3. Pregnant, diabetic or immunocompromised
  4. Prior endodontic treatment of the same tooth
  5. History of antibiotic use in past one month or requiring antibiotic pre-medication
  6. unrestorable teeth, fractured or perforated roots, grade 3 mobility

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Patency Group

    Non Patency Group

    Arm Description

    apical patency was maintained during chemomechanical preparation

    Apical patency was not maintained during chemomechanical preparation

    Outcomes

    Primary Outcome Measures

    Change in periapical radiolucency
    The change observed in periapical radiolucency at the 12-month follow-up visit was used to assess the success of the treatment

    Secondary Outcome Measures

    Clinical success
    Absence of pain and tenderness to percussion/palpation, the absence of sinus or any associated soft-tissue swelling, tooth mobility of grade 1 or less, and no deterioration in periodontal probing depth as compared with baseline measurements

    Full Information

    First Posted
    February 19, 2018
    Last Updated
    March 4, 2018
    Sponsor
    Postgraduate Institute of Dental Sciences Rohtak
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03454815
    Brief Title
    Effect of Apical Patency on Success of Root Canal Treatment in Non Vital Teeth
    Official Title
    Effect of Apical Patency on Success of Primary Non-surgical Root Canal Treatment in Non Vital Teeth - a Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2013 (Actual)
    Primary Completion Date
    November 28, 2013 (Actual)
    Study Completion Date
    November 30, 2014 (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
    Maintaining Apical patency during root canal treatment is a widely followed methodology in modern endodontic treatment protocols. It involves passing of a small #08 or #10 K file through the apical foramen during root canal shaping without widening it. it is done to keep the foramen and apical thirds of root canal free of debris. proponents of the procedure claim it to improve irrigation; provide better tactile feedback; reduce the chances of procedural errors; reduce transportation and reduce pain following root canal procedures. however, there is no clinical trial which specifically evaluates the effect of apical patency on outcome of root canal procedure. hence this study was designed to evaluate the effect of apical patency on outcome of root canal treatment.
    Detailed Description
    AIM: To assess the role of maintaining Apical Patency on success of primary Non-Surgical Root Canal Treatment (NSRCT) in Non-Vital teeth. To evaluate the incidence of post-operative complications such as pain, flare-up etc with and without maintaining apical patency. Study subjects were recruited from the pool of patients referred for the initial non-surgical root canal treatment to the post graduate department Of Conservative Dentistry & Endodontics at PGIDS, Rohtak (Haryana). Patients requiring Root Canal Treatment following the diagnosis pulpal necrosis in mature mandibular first molar were selected for the study. Clinical procedure: Subjects were randomly allocated to one of the two study groups (patency or non-patency). It was ensured that neither the patient, nor the primary investigator was aware of the treatment protocol before completing the consent process. After administration of local anesthesia, rubber dam isolation of the involved tooth was done. Caries excavation was done and access cavity prepared using carbide burs in high speed handpiece with copious irrigation. Debridement of the pulp chamber was done and all canal orifices identified. Working length was obtained with the help of electronic apex locator (Root ZX) and confirmed radiographically. ProTaper S1 and Sx were used to flare coronal thirds and WL was reconfirmed with apex locator. Hand files No. 10, 15 and 20 were used till working length (WL) to prepare a smooth reproducible glide path. ProTaper S1 and S2 were used till WL, followed by the use of ProTaper finishing files (F1/F2/F3) to prepare the canal to desired size as determined by the operator. Copious irrigation with 3% Sodium Hypochlorite was carried out throughout the procedure with the use of 27-gauge side vented needle. In patency group, a #10 K- file was passed 1mm beyond the WL between each instrument change, while in non-patency group it was carried till the WL. In patency group, a final radiograph was taken after completion of preparation, with a #10 file placed 1mm beyond the WL to confirm patency. After enlargement, the canals were irrigated with 5ml 17% EDTA for 1 min followed by irrigation with 5ml 3% NaOCl. Canals were dried with absorbent paper points and filled with a paste made by mixing Calcium hydroxide powder with 2% Chlorhexidine liquid; and the access cavity restored with intermediate restorative material (IRM). The patient was recalled after 1 week. At the next appointment, the paste was removed with H- files and copious irrigation with 3% NaOCl. Canals were examined under operating microscpe. A final rinse of 5ml 17% EDTA and 5ml 3% NaOCl was done and canals dried with paper points. Canals were obturated with the GuttaPercha and Zinc Oxide- Eugenol based sealer. After obturation, the cavity was restored with Silver Amalgam/Composite/Full coverage crown. Immediate post-operative radiograph was then taken using preset exposure parameters with Rinn paralleling device; and processed manually. Follow up clinical and radiographic examination was carried out every 3 months, till a 12 month period. Data Gathering Details: Preoperative and intraoperative data were obtained from patient records. Diagnostic and treatment information was meticulously recorded on a custom designed endodontic treatment form by the operator. Diagnostic and treatment details for each patient were extracted from the records by the principal investigator. Assessment of treatment outcome: Treatment outcome was judged on the basis of clinical and radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit Radiographic success: Change in Periapical Index (PAI) scores (Orstaviket al) observed at 12-months was noted. Scoring of each tooth was done according to the following five point scale (PAI): PAI Score Description of radiographic findings Normal periapical structures Small changes in bone structure Changes in bone structure with some mineral loss Periodontitis with well-defined radiolucent area Severe periodontitis with exacerbating features Three experienced observers with no knowledge of the treatment protocol independently examined immediate post obturation and follow-up radiographs, mounted side by side, under controlled conditions. The treatment was considered successful only when both clinical and radiographic criteria were met. In multirooted teeth, the worst outcome by root decided the overall outcome for the tooth. In the event of disagreement, the three observers met to discuss their findings and came to an agreement. In the absence of unanimity, the majority decision was taken. Clinical Success: Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Apical Periodontitis
    Keywords
    Apical Patency, Root Canal Treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patency Group
    Arm Type
    Experimental
    Arm Description
    apical patency was maintained during chemomechanical preparation
    Arm Title
    Non Patency Group
    Arm Type
    No Intervention
    Arm Description
    Apical patency was not maintained during chemomechanical preparation
    Intervention Type
    Procedure
    Intervention Name(s)
    Apical patency
    Intervention Description
    Apical patency was maintained by passing a #10 K file 1 mm beyond working length between every instrument change while doing chemomechanical preparation
    Primary Outcome Measure Information:
    Title
    Change in periapical radiolucency
    Description
    The change observed in periapical radiolucency at the 12-month follow-up visit was used to assess the success of the treatment
    Time Frame
    Baseline to 12-month
    Secondary Outcome Measure Information:
    Title
    Clinical success
    Description
    Absence of pain and tenderness to percussion/palpation, the absence of sinus or any associated soft-tissue swelling, tooth mobility of grade 1 or less, and no deterioration in periodontal probing depth as compared with baseline measurements
    Time Frame
    Baseline to 12-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mature permanent mandibular first molars Diagnosis of pulp necrosis, as confirmed by negative response to cold and electrical tests Radiographic evidence of apical periodontitis (minimum size ≥ 2.0 × 2.0 mm) Probing depth < 4mm Exclusion Criteria: Non willingness to participate in study younger than 18 years of age Pregnant, diabetic or immunocompromised Prior endodontic treatment of the same tooth History of antibiotic use in past one month or requiring antibiotic pre-medication unrestorable teeth, fractured or perforated roots, grade 3 mobility

    12. IPD Sharing Statement

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    Effect of Apical Patency on Success of Root Canal Treatment in Non Vital Teeth

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