CClinicalTrials.gg
CompletedNCT03894722Updated Mar 28, 2019

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

A Phase 4 interventional study of Control and 0.5% concentration of PVP-I in Impacted Third Molar Tooth, sponsored by Cansu Gül Koca. Completed. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by Cansu Gül Koca · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Oct 2016, registered Mar 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Impacted Third Molar Tooth

Keywords

  • third molar surgery
  • povidone iodine
03

In context

Tooth, Impacted

195 studies on the registry are indexed under Tooth, Impacted; 20 are open to participants now.

This study's enrollment of 80 is above the median of 53 across 164 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

This is the only study on the registry with Cansu Gül Koca as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Placebo comparator
    Group I (control; saline only)

    Control Group: Intraoperative irrigation with saline solution only.

    Procedure: Control

  • 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

  • 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

  • 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

Interventions

  • ProcedureControl

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

  • Procedure0.5% concentration of PVP-I

    During the third molar extraction 0.5% concentration of PVP-I solution will be used in the test group.

  • Procedure1 % concentration of PVP-I

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

  • Procedure3 % concentration of PVP-I

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day

  2. 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.

    Time frame: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 33475533 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03894722
Lead sponsor
Cansu Gül Koca
Responsible party
Cansu Gül Koca (Head Of Department, Assistant Professor Doctor, Uşak University) — Sponsor-investigator
First posted
Mar 28, 2019
Start date
Oct 3, 2016
Primary completion
Feb 9, 2018
Completion
Feb 9, 2018
Last update
Mar 28, 2019

Oversight

FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion