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

Study Overview
=================
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.

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

Conditions
-----------------
Impacted Third Molar Tooth

Intervention / Treatment
-----------------
* Procedure: Control
* Procedure: 0.5% concentration of PVP-I
* Procedure: 1 % concentration of PVP-I
* Procedure: 3 % concentration of PVP-I


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

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) | 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 | 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) | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
third molar surgery, povidone iodine