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Does Post-operative Rinsing With a Monoject Syringe Result in as Much Post-operative Pain After Surgical Removal of Lower Impact Third Molars as no Post-operative Rinsing: a Randomized Controlled Equivalence Trial (RITOR)

Primary Purpose

Third Molar

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monoject syringe
Sponsored by
Isala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Third Molar

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: patients over 18 years of age (non-smoking) referred for removal of a wisdom tooth in the mandible. Patient has ASA I. Exclusion Criteria: Patient is younger than 18 years Patient has an ASA of II,III en IV Patient has only one maxillary third molar that needs to be extracted/removed Patient has an active pericoronitis In case of planned coronectomy Patient has trismus Patient has chronic pain Patient is pregnant Patient has a known allergy for ibuprofen of other NSAID's Patient has a known allergy for articaine of epinefrine Intra-operative compilations for example excessive bleeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    No rinsing

    Monoject rinsing

    Arm Description

    Outcomes

    Primary Outcome Measures

    NRS pain
    pain score

    Secondary Outcome Measures

    Full Information

    First Posted
    May 8, 2023
    Last Updated
    May 8, 2023
    Sponsor
    Isala
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05860686
    Brief Title
    Does Post-operative Rinsing With a Monoject Syringe Result in as Much Post-operative Pain After Surgical Removal of Lower Impact Third Molars as no Post-operative Rinsing: a Randomized Controlled Equivalence Trial
    Acronym
    RITOR
    Official Title
    Does Post-operative Rinsing With a Monoject Syringe Result in as Much Post-operative Pain After Surgical Removal of Lower Impact Third Molars as no Post-operative Rinsing: a Randomized Controlled Equivalence Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

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

    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
    Many authors have advocated different methods of treating alveolar osteitis. Despite many years of research, however, little progress has been made and so a study with large enough sample and standard outcome measures is warranted. Goal of this study is assess the effect of postoperative use of a monoject syringe on postoperative complaints after surgical removal of a lower third molar.
    Detailed Description
    One of the most common postoperative complications after the removal of a third molar is a condition known as dry socket. This term has been in use since 1896. Since then several other terms have been used, including alveolar osteitis, postoperative alveolitis, alveolitis, sicca dolorosa and fibriniolytic alveolitis. Bim labelled the complication fibrinolytic alveolitis which is the most accurate of the terms, but also the least used. The condition has generally been characterised by delayed healing associated with degradadtion of clot, and is usually accompanied by persistent, radiating, pain postoperativively in and around the extraction site that is not easily relieved by analgesics. Because of the pain, swelling and trismus, patients also tend to have a greater need for painkillers. If it is possible to reduce the amount and severity of postoperative pain felt by patients the postoperative period would be more endurable, the quality of life will be less affected, and in addition to this it is possible that the amount of analgesics taken by patients after surgery could be lowered7. It can be a burden for both patients an surgeons and my result in a loss of productivity because at least 45% of patients require multiple visits to the surgeon. Objective of the study: Many authors have advocated different methods of treating alveolar osteitis. Despite many years of research, however, little progress has been made and so a study with large enough sample and standard outcome measures is warranted. Goal of this study is assess the effect of postoperative use of a monoject syringe on postoperative complaints after surgical removal of a lower third molar

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Third Molar

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Double blind randomized clinical trial
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    No rinsing
    Arm Type
    Active Comparator
    Arm Title
    Monoject rinsing
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Monoject syringe
    Intervention Description
    monoject syringe is used to clean the wound
    Primary Outcome Measure Information:
    Title
    NRS pain
    Description
    pain score
    Time Frame
    7 days after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: patients over 18 years of age (non-smoking) referred for removal of a wisdom tooth in the mandible. Patient has ASA I. Exclusion Criteria: Patient is younger than 18 years Patient has an ASA of II,III en IV Patient has only one maxillary third molar that needs to be extracted/removed Patient has an active pericoronitis In case of planned coronectomy Patient has trismus Patient has chronic pain Patient is pregnant Patient has a known allergy for ibuprofen of other NSAID's Patient has a known allergy for articaine of epinefrine Intra-operative compilations for example excessive bleeding

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Does Post-operative Rinsing With a Monoject Syringe Result in as Much Post-operative Pain After Surgical Removal of Lower Impact Third Molars as no Post-operative Rinsing: a Randomized Controlled Equivalence Trial

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