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

March 27, 2019 updated by: Cansu Gül Koca

Effects of Polyvinylpyrrolidone Iodine Concentrations on Postoperative Trismus and Swelling Using as an Irrigation Solution During Impacted Third Molar Surgery : a Randomized Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day
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.
Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cansu Gül Koca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 3, 2016

Primary Completion (ACTUAL)

February 9, 2018

Study Completion (ACTUAL)

February 9, 2018

Study Registration Dates

First Submitted

March 24, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (ACTUAL)

March 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHR: 2016-8/11

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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