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

Phase 4

Completed

• Conditions: Impacted Third Molar Tooth
• Interventions: Procedure: Control; Procedure: 1 % concentration of PVP-I; Procedure: 3 % concentration of PVP-I; Procedure: 0.5% concentration of PVP-I

• Registration Number: NCT03894722
• Lead Sponsor: Cansu Gül Koca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-03
• Primary Completion: 2018-02-09
• Study Completion: 2018-02-09
• Status Verified: 2019-03
• Study First Submitted: 2019-03-24
• Study First Submitted QC: 2019-03-27
• Last Update Submitted: 2019-03-27
• Study First Posted: 2019-03-28
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (control; saline only)	Control	Control Group: Intraoperative irrigation with saline solution only.
Group III (1% concentration of PVP-I)	1 % concentration of PVP-I	Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution.
Group IV (3% concentration of PVP-I)	3 % concentration of PVP-I	Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution.
Group II (0.5% concentration of PVP-I )	0.5% concentration of PVP-I	Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution.

Primary Outcome Measures

Name	Time	Method
Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery)	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
Postoperative Trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)	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.