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Occlusal Reduction and Postoperative Pain

Primary Purpose

Postoperative Pain

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

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

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

Inclusion Criteria:

  • healthy adults of 18-50 years. The diagnosis of symptomatic irreversible pulpitis with symptomatic apical periodontitis in a posterior mandibular tooth was confirmed by history of chief complaint of moderate to severe lingering sharp throbbing pain with pain on biting, clinical examination revealing positive response to an electrical pulp tester and tenderness to percussion on tapping the tooth with the end of a mirror handle, and radiographic examination showing posterior tooth with no apical radiolucency or slight widening of lamina dura.

Exclusion Criteria:

  • pregnant women, patients who reported bruxism or clenching, or patients who have administrated analgesics preoperatively during the past 12 hours that might alter their pain perception. Teeth that had no occlusal contact, no sensitivity to percussion, association with swelling or fistulous tract, greater than grade I mobility, or no possible restorability were also excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Occlusal Reduction

    non-occlusal reduction

    Arm Description

    performing occlusal reduction on functional cusps until abscence of contact was confirmed

    occlusal surface left intact

    Outcomes

    Primary Outcome Measures

    postinstrumentation pain
    postoperative pain was measured using visual analogue scale (VAS) following root canal instrumentation
    postobturation pain
    postoperative pain was measured using visual analogue scale (VAS) following root canal obturation

    Secondary Outcome Measures

    incidence of placebo and analgesic intake
    The incidence of placebo intake and number of analgesic tablets taken were recorded by the patients.

    Full Information

    First Posted
    April 6, 2017
    Last Updated
    April 12, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03117062
    Brief Title
    Occlusal Reduction and Postoperative Pain
    Official Title
    Evaluation of Postoperative Pain Intensity Following Occlusal Reduction in Teeth Associated With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (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 purpose of this randomized clinical study was to evaluate the impact of occlusal reduction on the incidences of post-instrumentation and post-obturation pain. Forty four patients were included in this study. Inclusion criteria were posterior mandibular teeth having symptomatic irreversible pulpitis and symptomatic apical periodontitis. Patients were randomized into two equal groups. In the intervention group the functional and nonfunctional cusps were reduced until absence of contact was confirmed, while in the control group the occlusal surfaces were left intact. Standard endodontic treatment was performed in two visits using rotary nickel titanium files for shaping, 2.5% sodium hypochlorite for cleaning and lateral condensation technique with resin sealer for obturation. Pain was assessed preoperatively, then after 6, 12, 24 and 48 hours following instrumentation, then after 6 and 12 hours following obturation. Visual Analogue Scale (VAS) was used as the primary outcome measure. Patients were given a placebo to be administrated in case of severe pain and ibuprofen 400mg was prescribed in case of persistent pain.
    Detailed Description
    Recruitment of the study participants was done from the outpatient clinic of the Endodontic Department of the Faculty of Oral and Dental Medicine, Cairo University. Randomization was done to assign participants to the study groups by chance and not choice. 44 numbers were generated and randomly allocated to either intervention or control group on a table using Microsoft Office Excel 2010. Each participant was given a number from 1 to 44 according to his turn in enrollment in the study. Root canal treatment was completed in two visits. Before treatment, each patient was given pain scale chart and was asked to record their pain level. The tooth was anesthetized using inferior alveolar nerve block technique by local anesthesia of 1.8 - 3.6 ml of 2% Mepivacaine HCl. The access cavity preparation was performed using round carbide bur and Endo-z bur. After access cavity in the intervention group, all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges were reduced using a wheel diamond bur. Absence of contact was confirmed using an articulating paper. In the control group, all occlusal contacts were left intact. The tooth was then properly isolated with rubber dam. The patency of the root canals was confirmed using stainless steel hand K-files size #10 and #15. Working length was determined using an electronic apex locator and confirmed radiographically to be 1 mm shorter than radiographic apex. Mechanical preparation was done by crown-down technique using rotary Revo-S instruments and Ethylene Diamine Tetra Aceticacid gel as a lubricant. The canals were thoroughly irrigated using 3ml of 2.5% sodium hypochlorite following each instrument. After dryness of the canals using paper points, a cotton pellet was placed in the pulp chamber and the access cavity was sealed with a temporary filling. After 7 days, the root canals were obturated with lateral condensation technique using 0.04 taper gutta-percha and AdSeal resin-based root canal sealer. Degree of postoperative pain was measured using visual analogue scale (VAS) after 6, 12, 24 and 48 hours after instrumentation then at 6 and 12 hours after obturation. The VAS consists of a 10-cm line anchored by two extremes "No pain" and "pain as bad as could be". The patients were asked to choose the mark that represents their level of pain. Pain level was assigned to one of four categorical scores: 1, None(0); 2,Mild(1-3); 3,Moderate(4-6); 4,Severe(7-10) 10. In case of moderate to severe postoperative pain, the patients were instructed to take a capsule of placebo given to him/her at the end of each visit. In case of persistent pain, patients were allowed to take Ibuprofen 400mg. The incidence of placebo intake and number of analgesic tablets taken were recorded by the patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Occlusal Reduction
    Arm Type
    Experimental
    Arm Description
    performing occlusal reduction on functional cusps until abscence of contact was confirmed
    Arm Title
    non-occlusal reduction
    Arm Type
    No Intervention
    Arm Description
    occlusal surface left intact
    Intervention Type
    Other
    Intervention Name(s)
    occlusal reduction
    Other Intervention Name(s)
    occlusal relief
    Intervention Description
    relief of occlusion following endodontic treatment
    Primary Outcome Measure Information:
    Title
    postinstrumentation pain
    Description
    postoperative pain was measured using visual analogue scale (VAS) following root canal instrumentation
    Time Frame
    up to 48 hours following instrumentation
    Title
    postobturation pain
    Description
    postoperative pain was measured using visual analogue scale (VAS) following root canal obturation
    Time Frame
    upto 24 hours following obturation
    Secondary Outcome Measure Information:
    Title
    incidence of placebo and analgesic intake
    Description
    The incidence of placebo intake and number of analgesic tablets taken were recorded by the patients.
    Time Frame
    up to 48 hours following each visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy adults of 18-50 years. The diagnosis of symptomatic irreversible pulpitis with symptomatic apical periodontitis in a posterior mandibular tooth was confirmed by history of chief complaint of moderate to severe lingering sharp throbbing pain with pain on biting, clinical examination revealing positive response to an electrical pulp tester and tenderness to percussion on tapping the tooth with the end of a mirror handle, and radiographic examination showing posterior tooth with no apical radiolucency or slight widening of lamina dura. Exclusion Criteria: pregnant women, patients who reported bruxism or clenching, or patients who have administrated analgesics preoperatively during the past 12 hours that might alter their pain perception. Teeth that had no occlusal contact, no sensitivity to percussion, association with swelling or fistulous tract, greater than grade I mobility, or no possible restorability were also excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Radwa S Emara, Masters
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD data are confidential and secured. Only accessed by principal investigator and supervisors

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    Occlusal Reduction and Postoperative Pain

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