Effect of Low Level Laser Therapy After Wisdom Tooth Removal

Effect of Low Level Laser Therapy After Wisdom Tooth Removal on Swelling, Pain and Mouth Opening in a Randomized, Double-blind Split-mouth Study

The aim is to test the effect of low level laser therapy on the relief of symptoms after wisdom tooth removal.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Wound Heal; Tooth, Impacted
• Intervention / Treatment: Device: Use of Low level Laser 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mona Schiefersteiner, Dr.; Phone Number: 0041 44 634 32 90; Email: mona.schiefersteiner@zzm.uzh.ch

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Recruiting
    • Center of dental medicine
    • Contact: Mona Schiefersteiner, Dr.; Phone Number: 0041 44 634 32 90; Email: mona.schiefersteiner@zzm.uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low Level Laser; therapeutic laser	Device: Use of Low level Laser after wisdom tooth removal; Directly after the wisdom teeth removal of the right/left side, one of the low level laser (therapeutic and non-therapeutic (Placebo)) is used.
Placebo Comparator: Placebo Low Level Laser; non-therapeutic laser	Device: Use of Low level Laser after wisdom tooth removal; Directly after the wisdom teeth removal of the right/left side, one of the low level laser (therapeutic and non-therapeutic (Placebo)) is used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Measurement of Pain with a visual analogue scale (VAS) 0-10	3 days after wisdom tooth removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Measurement of Pain with a visual analogue scale (VAS) 0-10	7 days after wisdom tooth removal
Postoperative Swelling	Measurement of swelling with an extraoral scan	3 and 7 days after wisdom tooth removal
Postoperative Mouth opening	Measurement of mouth opening	3 and 7 days after wisdom tooth removal

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Study Director: Martin Ruecker, Prof., Clinic for maxillofacial and oral surgery

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Wisdom tooth; Low Level Laser
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: 2019-00949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No