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Effect of Low Level Laser Therapy After Wisdom Tooth Removal

Primary Purpose

Tooth, Impacted, Wound Heal, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Use of Low level Laser after wisdom tooth removal
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth, Impacted focused on measuring Wisdom tooth, Low Level Laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Indication for prophylactical wisdom tooth removal
  • 4 wisdom teeth

Exclusion Criteria:

  • pregnancy
  • taking blood thinners
  • known infectious diseases
  • untreated diabetes mellitus
  • taking immunosuppressants
  • Previous infections in the area of the wisdom teeth
  • smoking

Sites / Locations

  • Center of dental medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Low Level Laser

Placebo Low Level Laser

Arm Description

therapeutic laser

non-therapeutic laser

Outcomes

Primary Outcome Measures

Postoperative Pain
Measurement of Pain with a visual analogue scale (VAS) 0-10

Secondary Outcome Measures

Postoperative Pain
Measurement of Pain with a visual analogue scale (VAS) 0-10
Postoperative Swelling
Measurement of swelling with an extraoral scan
Postoperative Mouth opening
Measurement of mouth opening

Full Information

First Posted
June 15, 2020
Last Updated
November 17, 2020
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04437316
Brief Title
Effect of Low Level Laser Therapy After Wisdom Tooth Removal
Official Title
Effect of Low Level Laser Therapy After Wisdom Tooth Removal on Swelling, Pain and Mouth Opening in a Randomized, Double-blind Split-mouth Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim is to test the effect of low level laser therapy on the relief of symptoms after wisdom tooth removal.
Detailed Description
Each Patient will get all four wisdom teeth removed, left and right side separately. After the operation, low level laser therapy is applied intra- and extraorally. Two different lasers are used, one for each side. The two lasers look identical. Only one of the lasers has therapeutic light, the other one shows just non-therapeutic red light. The effect of the low level laser is measured by several parameters and they are compared with the other side. These parameters are pain, swelling and mouth opening. The selection of the lasers to the sides is double-blind and randomized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Impacted, Wound Heal, Quality of Life
Keywords
Wisdom tooth, Low Level Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split-mouth design
Masking
ParticipantCare ProviderInvestigator
Masking Description
double-blind, randomized study
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Level Laser
Arm Type
Active Comparator
Arm Description
therapeutic laser
Arm Title
Placebo Low Level Laser
Arm Type
Placebo Comparator
Arm Description
non-therapeutic laser
Intervention Type
Device
Intervention Name(s)
Use of Low level Laser after wisdom tooth removal
Intervention Description
Directly after the wisdom teeth removal of the right/left side, one of the low level laser (therapeutic and non-therapeutic (Placebo)) is used.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Measurement of Pain with a visual analogue scale (VAS) 0-10
Time Frame
3 days after wisdom tooth removal
Secondary Outcome Measure Information:
Title
Postoperative Pain
Description
Measurement of Pain with a visual analogue scale (VAS) 0-10
Time Frame
7 days after wisdom tooth removal
Title
Postoperative Swelling
Description
Measurement of swelling with an extraoral scan
Time Frame
3 and 7 days after wisdom tooth removal
Title
Postoperative Mouth opening
Description
Measurement of mouth opening
Time Frame
3 and 7 days after wisdom tooth removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Indication for prophylactical wisdom tooth removal 4 wisdom teeth Exclusion Criteria: pregnancy taking blood thinners known infectious diseases untreated diabetes mellitus taking immunosuppressants Previous infections in the area of the wisdom teeth smoking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Schiefersteiner, Dr.
Phone
0041 44 634 32 90
Email
mona.schiefersteiner@zzm.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Ruecker, Prof.
Organizational Affiliation
Clinic for maxillofacial and oral surgery
Official's Role
Study Director
Facility Information:
Facility Name
Center of dental medicine
City
Zürich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Schiefersteiner, Dr.
Phone
0041 44 634 32 90
Email
mona.schiefersteiner@zzm.uzh.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Low Level Laser Therapy After Wisdom Tooth Removal

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