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Effect of Occlusal Reduction on Post-operative Pain

Primary Purpose

Evaluate Occlusal Reduction on Post-operative Pain, Teeth With Symptomatic Irreversible Pulpitis, Apical Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
occlusal surface reduction
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Evaluate Occlusal Reduction on Post-operative Pain

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patient's age between 20-50 years with no sex predilection.
  2. Medically free patients.

  3. Patients suffering from symptomatic irreversible pulpitis with symptomatic apical periodontitis in maxillary and mandibular molars with:

    • Preoperative pain.
    • Vital pulp.
    • Sensitivity to percussion.
    • Occlusal contact with the opposing teeth.
    • Normal periapical radiographic appearance or slight widening in the periodontal membrane space.

Exclusion Criteria:

  1. Pregnant females.
  2. Patients having a significant systemic disorder.
  3. Patients who had administered analgesics or antibiotics during the last 12 hours preoperatively.
  4. Patients having bruxism or clenching.

  5. Teeth having :

    • No occlusal contact.
    • No sensitivity to percussion.
    • Association with swelling or fistulous tract.
    • Acute or chronic peri-apical abscess.
    • Greater than grade I mobility.
    • Pocket depth greater than 5mm.
    • No possible restorability.
    • Previous endodontic treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    occlusal surface reduction

    no occlusal surface reduction

    Arm Description

    occlusal surface reduction after single visit root canal treatment

    No occlusal surface reduction after single visit root canal treatment

    Outcomes

    Primary Outcome Measures

    pre-operative pain before single visit root canal treatment by NRS (numerical rating scale)
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
    post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
    post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
    post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
    post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2017
    Last Updated
    June 15, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03189771
    Brief Title
    Effect of Occlusal Reduction on Post-operative Pain
    Official Title
    Effect of Occlusal Reduction on Post-operative Pain in Patients With Irreversible Pulpitis and Symptomatic Apical Periodontitis Treated in a Single-visit: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 27, 2017 (Anticipated)
    Primary Completion Date
    July 1, 2018 (Anticipated)
    Study Completion Date
    July 30, 2018 (Anticipated)

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    effect of occlusal reduction on post-operative pain is evaluated after single visit root canal treatment in upper and lower molar teeth in patients with sypmtomatic irreversible pulpitis and apical periondontis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Evaluate Occlusal Reduction on Post-operative Pain, Teeth With Symptomatic Irreversible Pulpitis, Apical Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    occlusal surface reduction
    Arm Type
    Experimental
    Arm Description
    occlusal surface reduction after single visit root canal treatment
    Arm Title
    no occlusal surface reduction
    Arm Type
    Placebo Comparator
    Arm Description
    No occlusal surface reduction after single visit root canal treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    occlusal surface reduction
    Intervention Description
    occlusal surface reduction after single visit root canal treatment
    Primary Outcome Measure Information:
    Title
    pre-operative pain before single visit root canal treatment by NRS (numerical rating scale)
    Description
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
    Time Frame
    Baseline
    Title
    post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
    Description
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
    Time Frame
    after treatment by 6 hours
    Title
    post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
    Description
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
    Time Frame
    after treatment by 12 hours
    Title
    post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
    Description
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
    Time Frame
    after treatment by 24 hours
    Title
    post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
    Description
    Primary outcome will be assessed by NRS (numerical rating scale), the unit of measurement is categorical.The scale is from (0-10) (1-3) Mild pain (4-6) Moderate pain (7-10) Severe pain
    Time Frame
    after treatment by 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient's age between 20-50 years with no sex predilection. Medically free patients. Patients suffering from symptomatic irreversible pulpitis with symptomatic apical periodontitis in maxillary and mandibular molars with: Preoperative pain. Vital pulp. Sensitivity to percussion. Occlusal contact with the opposing teeth. Normal periapical radiographic appearance or slight widening in the periodontal membrane space. Exclusion Criteria: Pregnant females. Patients having a significant systemic disorder. Patients who had administered analgesics or antibiotics during the last 12 hours preoperatively. Patients having bruxism or clenching. Teeth having : No occlusal contact. No sensitivity to percussion. Association with swelling or fistulous tract. Acute or chronic peri-apical abscess. Greater than grade I mobility. Pocket depth greater than 5mm. No possible restorability. Previous endodontic treatment

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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