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

Impacted Third Molar Tooth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894722
• Other study ID #: CHR: 2016-8/11
• Status: Completed
• Phase: Phase 4
• Start date: October 3, 2016
• Est. completion date: February 9, 2018

Study information

• Verified date: March 2019
• Source: Usak University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 9, 2018
• Est. primary completion date: February 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted
• Trismus

Intervention

Procedure:
• Control
During the third molar extraction the saline solution will be used in the control group.
• 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.
• 1 % concentration of PVP-I
During the third molar extraction 1 % concentration of PVP-I solution will be used in the test group.
• 3 % concentration of PVP-I
During the third molar extraction 3 % concentration of PVP-I solution will be used in the test group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cansu Gül Koca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.