- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03894722
Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery
March 27, 2019 updated by: Cansu Gül Koca
Effects of Polyvinylpyrrolidone Iodine Concentrations on Postoperative Trismus and Swelling Using as an Irrigation Solution During Impacted Third Molar Surgery : a Randomized Clinical Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Group I (control; saline only)
Control Group: Intraoperative irrigation with saline solution only.
|
During the third molar extraction the saline solution will be used in the control group.
|
EXPERIMENTAL: Group II (0.5% concentration of PVP-I )
Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution.
|
During the third molar extraction 0.5% concentration of PVP-I solution will be used in the test group.
|
EXPERIMENTAL: Group III (1% concentration of PVP-I)
Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution.
|
During the third molar extraction 1 % concentration of PVP-I solution will be used in the test group.
|
EXPERIMENTAL: Group IV (3% concentration of PVP-I)
Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution.
|
During the third molar extraction 3 % concentration of PVP-I solution will be used in the test group.
|
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)
Time Frame: 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:
|
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)
Time Frame: 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.
|
Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 3, 2016
Primary Completion (ACTUAL)
February 9, 2018
Study Completion (ACTUAL)
February 9, 2018
Study Registration Dates
First Submitted
March 24, 2019
First Submitted That Met QC Criteria
March 27, 2019
First Posted (ACTUAL)
March 28, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 28, 2019
Last Update Submitted That Met QC Criteria
March 27, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHR: 2016-8/11
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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