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Post-endodontic Pain Survey

Primary Purpose

Postoperative Pain, Endodontic Disease, Obturation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical root canal treatment filled with WVT
Non-surgical root canal treatment filled with SBT
Sponsored by
Ya-Hsin Yu, DDS, MS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative Pain, Bioceramic, Root canal filling

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of asymptomatic or symptomatic irreversible pulpitis according to AAE consensus. The diagnosis was based on clinical examinations and confirmed upon accessing the teeth.
  • Consenting adults age 18 years and older
  • Non-contributory medical history (ASA Class I & II)
  • Included patients were given oral and written information agreed for participation and signed the informed consent

Exclusion Criteria:

  • Non-consenting patients and patients below 18 years of age
  • Medical history with ASA Class III & IV
  • Non-restorable teeth
  • Teeth with a non-vital pulp
  • Periodontal probing depths were more than 4mm
  • Pre-medication with antibiotics and/or analgesics 24 hours before the treatment
  • Patients taking analgesics routinely for non-dental reasons

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Obturation technique: WVT

    Obturation technique: SBT

    Arm Description

    Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.

    Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale (VAS)
    Patients were asked to rate the intensity of preoperative pain on a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain ever) before receiving root canal treatment. At the end of the visit, the patients were given a survey and asked to rate the intensity of postoperative pain (VAS 0-10) at 4 hours, 24 hours, and 48 hours after the procedure.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 24, 2020
    Last Updated
    September 11, 2020
    Sponsor
    Ya-Hsin Yu, DDS, MS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04462731
    Brief Title
    Post-endodontic Pain Survey
    Official Title
    Postoperative Pain After One-visit Root Canal Treatment on Teeth With Vital Pulps: Comparison of Two Different Root Filling Techniques
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    May 2018 (Actual)
    Study Completion Date
    May 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ya-Hsin Yu, DDS, MS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    As part of root canal treatment, canals should be sealed to prevent further contaminations. There are multiple accepted techniques to fill-obturate canals. In the past, different obturation techniques have been compared. The most current technique used, a single cone with bioceramic sealer, has not been compared. This clinical investigation will compare the postoperative pain of this technique to another common technique used in our clinic. Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: Comparison of three different obturation techniques.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Endodontic Disease, Obturation
    Keywords
    Postoperative Pain, Bioceramic, Root canal filling

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Non-surgical root canal treatment: All teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% NaOCl was used as the main irrigant. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% NaOCl and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    194 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Obturation technique: WVT
    Arm Type
    Experimental
    Arm Description
    Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.
    Arm Title
    Obturation technique: SBT
    Arm Type
    Active Comparator
    Arm Description
    Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-surgical root canal treatment filled with WVT
    Intervention Description
    All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. WVT was used to fill the tooth when the months were January, March, May, July, September, and November.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-surgical root canal treatment filled with SBT
    Intervention Description
    All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. SBT was used to fill the tooth when the months were February, April, June, August, October, and December.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (VAS)
    Description
    Patients were asked to rate the intensity of preoperative pain on a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain ever) before receiving root canal treatment. At the end of the visit, the patients were given a survey and asked to rate the intensity of postoperative pain (VAS 0-10) at 4 hours, 24 hours, and 48 hours after the procedure.
    Time Frame
    4-, 24-, and 48-hour after receiving root canal treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of asymptomatic or symptomatic irreversible pulpitis according to AAE consensus. The diagnosis was based on clinical examinations and confirmed upon accessing the teeth. Consenting adults age 18 years and older Non-contributory medical history (ASA Class I & II) Included patients were given oral and written information agreed for participation and signed the informed consent Exclusion Criteria: Non-consenting patients and patients below 18 years of age Medical history with ASA Class III & IV Non-restorable teeth Teeth with a non-vital pulp Periodontal probing depths were more than 4mm Pre-medication with antibiotics and/or analgesics 24 hours before the treatment Patients taking analgesics routinely for non-dental reasons

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    33555456
    Citation
    Yu YH, Kushnir L, Kohli M, Karabucak B. Comparing the incidence of postoperative pain after root canal filling with warm vertical obturation with resin-based sealer and sealer-based obturation with calcium silicate-based sealer: a prospective clinical trial. Clin Oral Investig. 2021 Aug;25(8):5033-5042. doi: 10.1007/s00784-021-03814-x. Epub 2021 Feb 8.
    Results Reference
    derived

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    Post-endodontic Pain Survey

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