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Completed

NCT Number: NCT03894722

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

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.

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Key information

Conditions

Impacted Third Molar Tooth

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Procedure

During the third molar extraction the saline solution will be used in the control group.

0.5% concentration of PVP-I

Procedure

During the third molar extraction 0.5% concentration of PVP-I solution will be used in the test group.

1 % concentration of PVP-I

Procedure

During the third molar extraction 1 % concentration of PVP-I solution will be used in the test group.

3 % concentration of PVP-I

Procedure

During the third molar extraction 3 % concentration of PVP-I solution will be used in the test group.

Primary outcomes

  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:

    • 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

  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.

Sponsors and collaborators

Lead sponsor

Cansu Gül Koca

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 28, 2019
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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