Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery
Primary Purpose
Impacted Third Molar Tooth
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Control
0.5% concentration of PVP-I
1 % concentration of PVP-I
3 % concentration of PVP-I
Sponsored by
About this trial
This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring third molar surgery, povidone iodine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Group I (control; saline only)
Group II (0.5% concentration of PVP-I )
Group III (1% concentration of PVP-I)
Group IV (3% concentration of PVP-I)
Arm Description
Control Group: Intraoperative irrigation with saline solution only.
Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution.
Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution.
Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03894722
Brief Title
Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
February 9, 2018 (Actual)
Study Completion Date
February 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cansu Gül Koca
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
third molar surgery, povidone iodine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (control; saline only)
Arm Type
Placebo Comparator
Arm Description
Control Group: Intraoperative irrigation with saline solution only.
Arm Title
Group II (0.5% concentration of PVP-I )
Arm Type
Experimental
Arm Description
Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution.
Arm Title
Group III (1% concentration of PVP-I)
Arm Type
Experimental
Arm Description
Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution.
Arm Title
Group IV (3% concentration of PVP-I)
Arm Type
Experimental
Arm Description
Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
During the third molar extraction the saline solution will be used in the control group.
Intervention Type
Procedure
Intervention Name(s)
0.5% concentration of PVP-I
Intervention Description
During the third molar extraction 0.5% concentration of PVP-I solution will be used in the test group.
Intervention Type
Procedure
Intervention Name(s)
1 % concentration of PVP-I
Intervention Description
During the third molar extraction 1 % concentration of PVP-I solution will be used in the test group.
Intervention Type
Procedure
Intervention Name(s)
3 % concentration of PVP-I
Intervention Description
During the third molar extraction 3 % concentration of PVP-I solution will be used in the test group.
Primary Outcome Measure Information:
Title
Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery)
Description
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
Time Frame
Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day
Title
Postoperative Trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
33475533
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery
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