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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03894722
Other study ID # CHR: 2016-8/11
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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