Tooth, ImpactedNCT04437316
Effect of Low Level Laser Therapy After Wisdom Tooth Removal
A study testing Use of Low level Laser after wisdom tooth removal in people with Tooth, Impacted and Wound Heal, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim is to test the effect of low level laser therapy on the relief of symptoms after wisdom tooth removal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted, Wound Heal, Quality of Life
- What is being tested?
- Use of Low level Laser after wisdom tooth removal
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication for prophylactical wisdom tooth removal
- 4 wisdom teeth
Who cannot join
- pregnancy
- taking blood thinners
- known infectious diseases
- untreated diabetes mellitus
- taking immunosuppressants
- Previous infections in the area of the wisdom teeth
- smoking
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Center of dental medicine
Zurich
Mona Schiefersteiner, Dr., 0041 44 634 32 90, mona.schiefersteiner@zzm.uzh.ch
About this study
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
The aim is to test the effect of low level laser therapy on the relief of symptoms after wisdom tooth removal.
Read the 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.
- Conditions
- Tooth, Impacted, Wound Heal, Quality of Life
- Being tested
- Use of Low level Laser after wisdom tooth removal
- Keywords
- Wisdom tooth, Low Level Laser
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser | Active comparator | therapeutic laser Receives: Device: Use of Low level Laser after wisdom tooth removal |
| Placebo Low Level Laser | Placebo comparator | non-therapeutic laser Receives: Device: Use of Low level Laser after wisdom tooth removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Measurement of Pain with a visual analogue scale (VAS) 0-10
Measured: 3 days after wisdom tooth removal
Secondary outcomes (3)
Postoperative Pain
Measurement of Pain with a visual analogue scale (VAS) 0-10
Measured: 7 days after wisdom tooth removal
Postoperative Swelling
Measurement of swelling with an extraoral scan
Measured: 3 and 7 days after wisdom tooth removal
Postoperative Mouth opening
Measurement of mouth opening
Measured: 3 and 7 days after wisdom tooth removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, ImpactedStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split-mouth design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Ruecker, Prof., Study director, Clinic for maxillofacial and oral surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437316
- Sponsor's protocol ID
- 2019-00949
- Other IDs
- 2019
- Status last verified
- Nov 2020
- First submitted
- 15 Jun 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04437316
- Acronym / sponsor ID
- 2019-00949
- Conditions
- Tooth, Impacted, Wound Heal, Quality of Life
- Keywords
- Wisdom tooth, Low Level Laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser | Active comparator | Device: Use of Low level Laser after wisdom tooth removaltherapeutic laser |
| Placebo Low Level Laser | Placebo comparator | Device: Use of Low level Laser after wisdom tooth removalnon-therapeutic laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for prophylactical wisdom tooth removal
- 4 wisdom teeth
Key exclusion criteria (7 listed)
- pregnancy
- taking blood thinners
- known infectious diseases
- untreated diabetes mellitus
- taking immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Low level Laser after wisdom tooth removalDirectly after the wisdom teeth removal of the right/left side, one of the low level laser (therapeutic and non-therapeutic (Placebo)) is used. | Device | Low Level Laser, Placebo Low Level Laser |
Primary outcome
Postoperative Pain
Time frame: 3 days after wisdom tooth removal
Measurement of Pain with a visual analogue scale (VAS) 0-10
3 secondary outcomes
Postoperative Pain
Time frame: 7 days after wisdom tooth removal
Postoperative Swelling
Time frame: 3 and 7 days after wisdom tooth removal
Postoperative Mouth opening
Time frame: 3 and 7 days after wisdom tooth removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Ruecker, Prof. study director
Clinic for maxillofacial and oral surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Low level Laser after wisdom tooth removal in people with Tooth, Impacted and Wound Heal, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona Schiefersteiner, Dr. (0041 44 634 32 90, mona.schiefersteiner@zzm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 3 days after wisdom tooth removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.