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

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ClinicalTrials.gov Identifier: NCT03894722
Recruitment Status : Completed
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Cansu Gül Koca, Uşak University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Procedure: Control Procedure: 0.5% concentration of PVP-I Procedure: 1 % concentration of PVP-I Procedure: 3 % concentration of PVP-I Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group I (control; saline only)
Control Group: Intraoperative irrigation with saline solution only.
 Procedure: Control
During the third molar extraction the saline solution will be used in the control group.
Experimental: Group II (0.5% concentration of PVP-I )
Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution.
 Procedure: 0.5% concentration of PVP-I
During the third molar extraction 0.5% concentration of PVP-I solution will be used in the test group.
Experimental: Group III (1% concentration of PVP-I)
Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution.
 Procedure: 1 % concentration of PVP-I
During the third molar extraction 1 % concentration of PVP-I solution will be used in the test group.
Experimental: Group IV (3% concentration of PVP-I)
Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution.
 Procedure: 3 % concentration of PVP-I
During the third molar extraction 3 % concentration of PVP-I solution will be used in the test group.


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery) [ Time Frame: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day ]

    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:

    1. the external canthus of the eye- the gonion angle
    2. the lower border of the tragus-the mouth commissure
    3. the lower border of the tragus- soft pogonion

  2. Postoperative Trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery) [ Time Frame: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day. ]
    The degree of trismus was assessed by measuring the distance between upper and lower incisal borders of the central incisors with a digital caliper.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cansu Gül Koca, Head Of Department, Assistant Professor Doctor, Uşak University
ClinicalTrials.gov Identifier: NCT03894722    
Other Study ID Numbers: CHR: 2016-8/11
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cansu Gül Koca, Uşak University:
third molar surgery
povidone iodine
Additional relevant MeSH terms:
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Tooth, Impacted
Trismus
Tooth Diseases
Stomatognathic Diseases
Spasm
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents