NCT04437316

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

12 months

First QC Date

June 15, 2020

Last Update Submit

November 17, 2020

Conditions

Tooth, ImpactedWound HealQuality of Life

Keywords

Wisdom toothLow Level Laser

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

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

    3 days after wisdom tooth removal

Secondary Outcomes (3)

  • Postoperative Pain

    7 days after wisdom tooth removal

  • Postoperative Swelling

    3 and 7 days after wisdom tooth removal

  • Postoperative Mouth opening

    3 and 7 days after wisdom tooth removal

Study Arms (2)

Low Level Laser

ACTIVE COMPARATOR

therapeutic laser

Device: Use of Low level Laser after wisdom tooth removal

Placebo Low Level Laser

PLACEBO COMPARATOR

non-therapeutic laser

Device: Use of Low level Laser after wisdom tooth removal

Interventions

Use of Low level Laser after wisdom tooth removalDEVICE

Directly after the wisdom teeth removal of the right/left side, one of the low level laser (therapeutic and non-therapeutic (Placebo)) is used.

Low Level LaserPlacebo Low Level Laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for prophylactical wisdom tooth removal
  • wisdom teeth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of dental medicine

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Martin Ruecker, Prof.

    Clinic for maxillofacial and oral surgery

    STUDY DIRECTOR

Central Study Contacts

Mona Schiefersteiner, Dr.

CONTACT

0041 44 634 32 90mona.schiefersteiner@zzm.uzh.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
double-blind, randomized study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: split-mouth design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

July 1, 2020

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)