Third Molar ExtractionNCT05255731
Effect of Low Power Laser in the Pain After Lower Tooth Extraction
A study testing Low frequency laser activated photobiomodulation and Low frequency laser photobiomodulation inactive in people with Third Molar Extraction and Oral Pain, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
Introduction: Previously published studies report a prevalence ranging from 35.9% to 58.7% of the general population with at least one impacted wisdom tooth. Surgical extraction of wisdom teeth is the procedure most often associated with postoperative complications, such as pain, swelling, trismus, and oral discomfort… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Third Molar Extraction, Oral Pain, Tooth Extraction
- What is being tested?
- Low frequency laser activated photobiomodulation and Low frequency laser photobiomodulation inactive
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2022to 30 Nov 2023
- 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
- Patients who require extraction of the two lower wisdom teeth due to previous infection or pain, orthodontics or crowding, caries and who have a similar degree of difficulty according to the Pell and Gregory/Winter classifications.
- Patients must have the capacity to understand and decide at the time of voluntarily signing the informed consent before any intervention related to the study is performed.
- Patients who, after being informed about the aims and procedures of the research, agree and sign the informed consent form. Patients must be willing and able to adhere to the study in order to complete the necessary visits.
Who cannot join
- Patients with uncontrolled systemic disease (ASA ≥ III).
- Patients with severe periodontal disease or acute pericoronitis.
- Smokers of more than 5 cigarettes per day.
- Pregnant and lactating women, as the effect of laser therapy in this population has not been studied, its use is contraindicated.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, 15785
About this study
Official title: Effect of the Low Power Laser in the Treatment of Pain After the Third Molar Lower Extraction. A Randomised Single-blind Clinical Trial Split-mouth
Introduction: Previously published studies report a prevalence ranging from 35.9% to 58.7% of the general population with at least one impacted wisdom tooth. Surgical extraction of wisdom teeth is the procedure most often associated with postoperative complications, such as pain, swelling, trismus, and oral discomfort during the first postoperative days. These complications arise from an inflammatory response, which is a direct and immediate consequence of the surgical intervention and can limit the patients' daily functions in the recovery phase and compromise their quality of life. Several methods have been used to control postoperative morbidity related to wisdom tooth extraction, including administration of proteolytic enzymes, tube drains, cryotherapy, anti-inflammatory and analgesic drugs and low level laser therapy.
Objectives: To test whether the use of low power laser can improve post-operative pain, swelling and healing of the surgical wound.
Material and methods: A double-centre, randomised, split-mouth, double-centre clinical study will be carried out in 38 patients per centre, totalling 76 patients and 152 wisdom teeth, who will undergo surgery for the extraction of the lower third molars. The necessary data for the study will be taken on the days of the consultation for surgery planning, on the day of surgery, by the patient on each post-operative day and on the 7th post-operative day (at the time of suture removal ).
- Conditions
- Third Molar Extraction, Oral Pain, Tooth Extraction
- Being tested
- Low frequency laser activated photobiomodulation, Low frequency laser photobiomodulation inactive
- Keywords
- Dentistry, Tooth extraction, Photobiomodulation, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low frequency laser activated photobiomodulationRadiation
Protocol description Infrared: analgesia, biostimulation of tissues, edema and hyperemia (hard and soft tissues). There will be 11 laser application points, 3 intra-oral and 8 extra-oral, with a total dose of 33J.
Intraoral: one point in the region of the mandibular lingula (point of submersion of the mandibular nerve), one vestibular point and one lingual point in relation to the alveolus of the extracted wisdom tooth.
Extraoral: for muscle relaxation, five points on the masseter muscle; for oedema drainage, one point in each lymph node region: parotid, submandibular and buccal.
Low frequency laser photobiomodulation inactiveOther
The same protocol as the activated group
| Study group | Role | What they receive |
|---|---|---|
| Laser Group (GL) | Active comparator | Patients will be submitted to a low power laser application immediately after suturing of the surgical area. The radiation emission shall be conducted according to protocol. Receives: Radiation: Low frequency laser activated photobiomodulation |
| Control Group (CG) | Placebo comparator | In these patients the investigators will use the same protocol applied in the experimental group (time and application values) but the laser device will be turn off. Receives: Other: Low frequency laser photobiomodulation inactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate edema after surgery
To evaluate the effect of diode laser radiation of 808 nm (infrared) applied intra and extra-orally on the post-operative edema (by measuring in centimetres obtained by a ruler - external contour of the face from the tragus to the labial comisure, from the gonion to the external ocular corner, the greater the measurement obtained, when compared with the initial measurement, the greater the post-operative edema).
Measured: 7 days
Secondary outcomes (3)
Reported pain
The degree of pain reported by patients using a visual analogue scale (VAS). Scale from 0 to 10, where zero means no pain and ten means severe pain
Measured: 7 days
Rescue medication for pain
To assess whether there has been a change in the amount of pills consumed as rescue medication for pain management. Through the number of pills used by the patient after each surgery.
Measured: 7 days
Trismus
With a ruler the distance of the maximum opening between the upper right and lower right central incisors before surgery will be measured (the measurement in centimetres). The smaller the measurement of mouth opening obtained, compared to the initial measurement, the greater the post-operative trismus)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start15 Feb 2022
- Primary completion30 Jul 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Molar ExtractionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255731
- Sponsor's protocol ID
- RCT-PBM/TM-USC/UB-22
- Status last verified
- Jul 2024
- First submitted
- 1 Feb 2022
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Low Power Laser in the Treatment of Pain After the Third Molar Lower Extraction. A Randomised Single-blind Clinical Trial Split-mouth
- ClinicalTrials.gov ID
- NCT05255731
- Acronym / sponsor ID
- RCT-PBM/TM-USC/UB-22
- Conditions
- Third Molar Extraction, Oral Pain, Tooth Extraction
- Keywords
- Dentistry, Tooth extraction, Photobiomodulation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 24 Feb 2022 (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.
Introduction: Previously published studies report a prevalence ranging from 35.9% to 58.7% of the general population with at least one impacted wisdom tooth. Surgical extraction of wisdom teeth is the procedure most often associated with postoperative complications, such as pain, swelling, trismus, and oral discomfort during the first postoperative days. These complications arise from an inflammatory response, which is a direct and immediate consequence of the surgical intervention and can limit the patients' daily functions in the recovery phase and compromise their quality of life. Several methods have been used to control postoperative morbidity related to wisdom tooth extraction, including administration of proteolytic enzymes, tube drains, cryotherapy, anti-inflammatory and analgesic drugs and low level laser therapy.
Objectives: To test whether the use of low power laser can improve post-operative pain, swelling and healing of the surgical wound.
Material and methods: A double-centre, randomised, split-mouth, double-centre clinical study will be carried out in 38 patients per centre, totalling 76 patients and 152 wisdom teeth, who will undergo surgery for the extraction of the lower third molars. The necessary data for the study will be taken on the days of the consultation for surgery planning, on the day of surgery, by the patient on each post-operative day and on the 7th post-operative day (at the time of suture removal ).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Group (GL) | Active comparator | Radiation: Low frequency laser activated photobiomodulationPatients will be submitted to a low power laser application immediately after suturing of the surgical area. The radiation emission shall be conducted according to protocol. |
| Control Group (CG) | Placebo comparator | Other: Low frequency laser photobiomodulation inactiveIn these patients the investigators will use the same protocol applied in the experimental group (time and application values) but the laser device will be turn off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who require extraction of the two lower wisdom teeth due to previous infection or pain, orthodontics or crowding, caries and who have a similar degree of difficulty according to the Pell and Gregory/Winter classifications.
- Patients must have the capacity to understand and decide at the time of voluntarily signing the informed consent before any intervention related to the study is performed.
- Patients who, after being informed about the aims and procedures of the research, agree and sign the informed consent form. Patients must be willing and able to adhere to the study in order to complete the necessary visits.
Key exclusion criteria (4 listed)
- Patients with uncontrolled systemic disease (ASA ≥ III).
- Patients with severe periodontal disease or acute pericoronitis.
- Smokers of more than 5 cigarettes per day.
- Pregnant and lactating women, as the effect of laser therapy in this population has not been studied, its use is contraindicated.
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 |
|---|---|---|
| Low frequency laser activated photobiomodulationProtocol description Infrared: analgesia, biostimulation of tissues, edema and hyperemia (hard and soft tissues). There will be 11 laser application points, 3 intra-oral and 8 extra-oral, with a total dose of 33J. Intraoral: one point in the region of the mandibular lingula (point of submersion of the mandibular nerve), one vestibular point and one lingual point in relation to the alveolus of the extracted wisdom tooth. Extraoral: for muscle relaxation, five points on the masseter muscle; for oedema drainage, one point in each lymph node region: parotid, submandibular and buccal. | Radiation | Laser Group (GL) |
| Low frequency laser photobiomodulation inactiveThe same protocol as the activated group | Other | Control Group (CG) |
Primary outcome
Evaluate edema after surgery
Time frame: 7 days
To evaluate the effect of diode laser radiation of 808 nm (infrared) applied intra and extra-orally on the post-operative edema (by measuring in centimetres obtained by a ruler - external contour of the face from the tragus to the labial comisure, from the gonion to the external ocular corner, the greater the measurement obtained, when compared with the initial measurement, the greater the post-operative edema).
3 secondary outcomes
Reported pain
Time frame: 7 days
Rescue medication for pain
Time frame: 7 days
Trismus
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Undecided. The investigators will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low frequency laser activated photobiomodulation and Low frequency laser photobiomodulation inactive in people with Third Molar Extraction and Oral Pain, run by University of Santiago de Compostela at 1 site in Spain.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Jul 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate edema after surgery (time frame: 7 days). 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 19 Jul 2024.