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

NCT03894722 | Completed Phase 4

• 1 other identifier: CHR: 2016-8/11
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impacted Third Molar Tooth

Keywords

third molar surgery; povidone iodine

Outcome Measures

Primary Outcomes (2)

• 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: 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)

  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.

Study Arms (4)

Group I (control; saline only)

PLACEBO COMPARATOR

Control Group: Intraoperative irrigation with saline solution only.

Procedure: Control

Group II (0.5% concentration of PVP-I )

EXPERIMENTAL

Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution.

Procedure: 0.5% concentration of PVP-I

Group III (1% concentration of PVP-I)

EXPERIMENTAL

Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution.

Procedure: 1 % concentration of PVP-I

Group IV (3% concentration of PVP-I)

EXPERIMENTAL

Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution.

Procedure: 3 % concentration of PVP-I

Interventions

Control PROCEDURE

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

Group I (control; saline only)

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.

Group II (0.5% concentration of PVP-I )

1 % concentration of PVP-I PROCEDURE

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

Group III (1% concentration of PVP-I)

3 % concentration of PVP-I PROCEDURE

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

Group IV (3% concentration of PVP-I)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Totally impacted mandibular third molars of class C, 1, 2, and 3 according to the Pell-Gregory classification;
• Has no systemic disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cansu Gül Koca: lead

Related Publications (1)

• Yuce E, Dereci O, Altin N, Koca CE, Yazan M. Effects of different polyvinylpyrrolidone iodine concentrations on trismus and swelling following third molar surgery. J Pak Med Assoc. 2020 Dec;70(12(B)):2304-2309. doi: 10.5455/JPMA.130.

  PMID: 33475533 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Of Department, Assistant Professor Doctor

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: March 28, 2019
• Study Start: October 3, 2016
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03