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Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Control
0.5% concentration of PVP-I
1 % concentration of PVP-I
3 % concentration of PVP-I
Sponsored by
Cansu Gül Koca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring third molar surgery, povidone iodine

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Totally impacted mandibular third molars of class C, 1, 2, and 3 according to the Pell-Gregory classification;
  • Has no systemic disease

Exclusion Criteria:

  • The use of medications that could interfere with the healing process;
  • Smoking;
  • Pregnancy or lactation;
  • Presence of any condition, such as inflammation, periodontitis, gingivitis and dental abscess in the area of the impacted teeth;
  • Undergoing antibiotic or anti-inflammatory drugs therapies in the 7 days before surgery;
  • History of hypersensitivity to iodine;
  • Has any thyroid diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Group I (control; saline only)

    Group II (0.5% concentration of PVP-I )

    Group III (1% concentration of PVP-I)

    Group IV (3% concentration of PVP-I)

    Arm Description

    Control Group: Intraoperative irrigation with saline solution only.

    Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution.

    Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution.

    Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution.

    Outcomes

    Primary Outcome Measures

    Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery)
    For the assessment of facial swelling, three facial lines (in milimeters) were measured with a digital tape on the operated side using following (4) landmarks: the external canthus of the eye, the gonion angle, the lower border of the tragus, soft pogonion and the mouth commissure Facial Lines between: the external canthus of the eye- the gonion angle the lower border of the tragus-the mouth commissure the lower border of the tragus- soft pogonion
    Postoperative Trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
    The degree of trismus was assessed by measuring the distance between upper and lower incisal borders of the central incisors with a digital caliper.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 24, 2019
    Last Updated
    March 27, 2019
    Sponsor
    Cansu Gül Koca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03894722
    Brief Title
    Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery
    Official Title
    Effects of Polyvinylpyrrolidone Iodine Concentrations on Postoperative Trismus and Swelling Using as an Irrigation Solution During Impacted Third Molar Surgery : a Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 3, 2016 (Actual)
    Primary Completion Date
    February 9, 2018 (Actual)
    Study Completion Date
    February 9, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Cansu Gül Koca

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of the present study was to evaluate the effects of different concentrations of povidone iodine (PVP-I) on postoperative swelling and trismus when used as a coolant and irrigation solution during the surgical removal of impacted mandibular third molars.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impacted Third Molar Tooth
    Keywords
    third molar surgery, povidone iodine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I (control; saline only)
    Arm Type
    Placebo Comparator
    Arm Description
    Control Group: Intraoperative irrigation with saline solution only.
    Arm Title
    Group II (0.5% concentration of PVP-I )
    Arm Type
    Experimental
    Arm Description
    Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution.
    Arm Title
    Group III (1% concentration of PVP-I)
    Arm Type
    Experimental
    Arm Description
    Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution.
    Arm Title
    Group IV (3% concentration of PVP-I)
    Arm Type
    Experimental
    Arm Description
    Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution.
    Intervention Type
    Procedure
    Intervention Name(s)
    Control
    Intervention Description
    During the third molar extraction the saline solution will be used in the control group.
    Intervention Type
    Procedure
    Intervention Name(s)
    0.5% concentration of PVP-I
    Intervention Description
    During the third molar extraction 0.5% concentration of PVP-I solution will be used in the test group.
    Intervention Type
    Procedure
    Intervention Name(s)
    1 % concentration of PVP-I
    Intervention Description
    During the third molar extraction 1 % concentration of PVP-I solution will be used in the test group.
    Intervention Type
    Procedure
    Intervention Name(s)
    3 % concentration of PVP-I
    Intervention Description
    During the third molar extraction 3 % concentration of PVP-I solution will be used in the test group.
    Primary Outcome Measure Information:
    Title
    Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery)
    Description
    For the assessment of facial swelling, three facial lines (in milimeters) were measured with a digital tape on the operated side using following (4) landmarks: the external canthus of the eye, the gonion angle, the lower border of the tragus, soft pogonion and the mouth commissure Facial Lines between: the external canthus of the eye- the gonion angle the lower border of the tragus-the mouth commissure the lower border of the tragus- soft pogonion
    Time Frame
    Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day
    Title
    Postoperative Trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
    Description
    The degree of trismus was assessed by measuring the distance between upper and lower incisal borders of the central incisors with a digital caliper.
    Time Frame
    Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Totally impacted mandibular third molars of class C, 1, 2, and 3 according to the Pell-Gregory classification; Has no systemic disease Exclusion Criteria: The use of medications that could interfere with the healing process; Smoking; Pregnancy or lactation; Presence of any condition, such as inflammation, periodontitis, gingivitis and dental abscess in the area of the impacted teeth; Undergoing antibiotic or anti-inflammatory drugs therapies in the 7 days before surgery; History of hypersensitivity to iodine; Has any thyroid diseases.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33475533
    Citation
    Yuce E, Dereci O, Altin N, Koca CE, Yazan M. Effects of different polyvinylpyrrolidone iodine concentrations on trismus and swelling following third molar surgery. J Pak Med Assoc. 2020 Dec;70(12(B)):2304-2309. doi: 10.5455/JPMA.130.
    Results Reference
    derived

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    Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery

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