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

NCT ID: NCT03894722

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-03

Study Completion Date

2018-02-09

Brief Summary

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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.

Detailed Description

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Conditions

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Impacted Third Molar Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group I (control; saline only)

Control Group: Intraoperative irrigation with saline solution only.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

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

Group II (0.5% concentration of PVP-I )

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

Group Type EXPERIMENTAL

0.5% concentration of PVP-I

Intervention Type PROCEDURE

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

Group III (1% concentration of PVP-I)

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

Group Type EXPERIMENTAL

1 % concentration of PVP-I

Intervention Type PROCEDURE

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

Group IV (3% concentration of PVP-I)

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

Group Type EXPERIMENTAL

3 % concentration of PVP-I

Intervention Type PROCEDURE

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

Interventions

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Control

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

1 % concentration of PVP-I

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

Intervention Type PROCEDURE

3 % concentration of PVP-I

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cansu Gül Koca

OTHER

Sponsor Role lead

Responsible Party

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Cansu Gül Koca

Head Of Department, Assistant Professor Doctor

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 33475533 (View on PubMed)

Other Identifiers

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CHR: 2016-8/11

Identifier Type: -

Identifier Source: org_study_id

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