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Occlusal Reduction Effect on Postendodontic Pain

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Occlusal reduction
Sham occlusal reduction
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Symptomatic Irreversible Pulpitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy adults 18-65 years old.
  • The diagnosis of symptomatic irreversible pulpitis with sensitivity to percussion.
  • Posterior mandibular teeth.

Exclusion Criteria:

  • Pregnant women.
  • Patients who reported bruxism or clenching.
  • Patients who took analgesics during the last 12 hours before treatment start.
  • Teeth with no occlusal contact.
  • Unrestorable teeth.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Occlusal reduction

    No occlusal reduction

    Arm Description

    Occlusal contacts on the functional and non-functional cusps were reduced.

    Occlusal surfaces kept intact. No actual occlusal reduction..

    Outcomes

    Primary Outcome Measures

    Post-instrumentation pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Post-instrumentation pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Post-instrumentation pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Post-instrumentation pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Post-obturation pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Post-obturation pain using a pain-measuring scale
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.

    Secondary Outcome Measures

    Sham analgesic intake incidence
    Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.
    Analgesic intake incidence
    Analgesic intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham analgesic intake.

    Full Information

    First Posted
    November 28, 2019
    Last Updated
    December 4, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04186897
    Brief Title
    Occlusal Reduction Effect on Postendodontic Pain
    Official Title
    Postendodontic Pain Following Occlusal Reduction in Mandibular Posterior Teeth: a Single-centre Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study, thus, was to assess the effect of occlusal reduction on postendodontic pain after the first (post-instrumentation) and the second (post-obturation) visit in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion treated in two visits.
    Detailed Description
    The purpose of this randomized clinical trial was to evaluate the effect of occlusal reduction on post-instrumentation and post-obturation pain in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion treated in two visits. Three hundred and eight patients were included in this study. Inclusion criteria were posterior mandibular teeth having symptomatic irreversible pulpitis with sensitivity to percussion. Patients were randomized into two equal groups. In the intervention group, occlusal reduction was done, while, in the control group, the occlusal surfaces were left intact. Conventional endodontic treatment was performed in two visits using a rotary nickel-titanium system followed by the lateral-condensation obturation technique. Post-instrumentation pain was assessed after 6, 12, 24 and 48 hours following the first visit, and post-obturation pain after 6 and 12 hours following the second visit. Each patient received a pain diary to record their pain levels and rescue medication intake.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Symptomatic Irreversible Pulpitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    308 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Occlusal reduction
    Arm Type
    Experimental
    Arm Description
    Occlusal contacts on the functional and non-functional cusps were reduced.
    Arm Title
    No occlusal reduction
    Arm Type
    Sham Comparator
    Arm Description
    Occlusal surfaces kept intact. No actual occlusal reduction..
    Intervention Type
    Procedure
    Intervention Name(s)
    Occlusal reduction
    Intervention Description
    Occlusal contacts on the functional and non-functional cusps were reduced.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham occlusal reduction
    Intervention Description
    The occlusal surface left intact. No actual occlusal reduction.
    Primary Outcome Measure Information:
    Title
    Post-instrumentation pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Time Frame
    6 hours
    Title
    Post-instrumentation pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Time Frame
    12 hours
    Title
    Post-instrumentation pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Time Frame
    24 hours
    Title
    Post-instrumentation pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Time Frame
    48 hours
    Title
    Post-obturation pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Time Frame
    6 hours
    Title
    Post-obturation pain using a pain-measuring scale
    Description
    Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
    Time Frame
    12 hours
    Secondary Outcome Measure Information:
    Title
    Sham analgesic intake incidence
    Description
    Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain.
    Time Frame
    7 days
    Title
    Analgesic intake incidence
    Description
    Analgesic intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham analgesic intake.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Healthy adults 18-65 years old. The diagnosis of symptomatic irreversible pulpitis with sensitivity to percussion. Posterior mandibular teeth. Exclusion Criteria: Pregnant women. Patients who reported bruxism or clenching. Patients who took analgesics during the last 12 hours before treatment start. Teeth with no occlusal contact. Unrestorable teeth.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Randa El Boghdadi, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9693578
    Citation
    Rosenberg PA, Babick PJ, Schertzer L, Leung A. The effect of occlusal reduction on pain after endodontic instrumentation. J Endod. 1998 Jul;24(7):492-6. doi: 10.1016/S0099-2399(98)80054-X.
    Results Reference
    background
    PubMed Identifier
    27129585
    Citation
    Arslan H, Seckin F, Kurklu D, Karatas E, Yanikoglu N, Capar ID. The effect of various occlusal reduction levels on postoperative pain in teeth with symptomatic apical periodontitis using computerized analysis: a prospective, randomized, double-blind study. Clin Oral Investig. 2017 Apr;21(3):857-863. doi: 10.1007/s00784-016-1835-y. Epub 2016 Apr 30.
    Results Reference
    background

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    Occlusal Reduction Effect on Postendodontic Pain

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