Pain, PostoperativePhase 2NCT03442166
Effectiveness of Light-emitting Diode (LED) Photobiomodulation in the Extraction of Retained Lower Third Molars
A Phase 2 study testing LED group in people with Pain, Postoperative and Edema, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
In dentistry, one of the most common surgical procedures is the removal of included third molars. This surgery generates great morbidity to patients for causing pain, edema and trismus due to surgical trauma. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Edema, Trismus
- What is being tested?
- LED group
- 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
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2018to 31 Dec 2019
- Phase
- Phase 2
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who need surgical removal of retained lower third molars;
- Patients who agree to participate in the study after reading and signing the Term of Consent for Participation in Clinical Research.
- Patients with indication for extraction of lower third molars (recurrent infections, bad position, orthodontic indication) or written professional indication (ASA I - negative medical history), systolic blood pressure less than 140mmHg, and diastolic blood pressure lower than 90mmHg and heart rate values of 70 ± 20 beats / minute and have the upper and lower central incisor teeth.
Who cannot join
- Patients who have systemic diseases, chronic pain or neurological and psychiatric disorders;
- Claim to be smokers;
- Are using anti-inflammatories, analgesics or bisphosphonates in the last 15 days;
- Present active pericoronaritis;
- Are pregnant;
- are breastfeeding;
Show all 11Show fewer
- Severe temporomandibular disorders
- Have photo sensitivity history
- Are allergic to any drug used in the research (paracetamol, chlorhexidine 2%)
- Patients presenting radiolucent images associated with the teeth to be extracted
- Patients who present any type of complication during surgery (hemorrhage, operative difficulty, time greater than 90 minutes of surgery), as these cases are not in the standard expected for third molar surgeries. In this case the central action analgesic will be prescribed. These data will not be part of the statistical analysis but will be described and discussed as well as possible adverse effects.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
UniNove
São Paulo, São Paulo, 01504-000
Sandra K Bussadori, PhD, 1126339000, sandra.skb@gmail.com
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial on the Effectiveness of Light-emitting Diode (LED) Photobiomodulation in Pain Management, Facial Edema, Trismus and Quality of Life After Extraction of Retained Lower Third Molars
In dentistry, one of the most common surgical procedures is the removal of included third molars. This surgery generates great morbidity to patients for causing pain, edema and trismus due to surgical trauma. The use of photobiomodulation (PBM) (low-power laser or light emitting diode - LED) in the postoperative of these procedures has shown excellent results in the control of postoperative sequelae. The objective of the present study is to evaluate the effectiveness of PBM with LED in the control of pain, facial edema, trismus and quality of life resulting from the extraction of retained lower third molars. A randomized, double-blind, placebo-controlled clinical trial involving 34 adult patients, who search the Discipline of Buccomaxillofacial Surgery and Traumatology (CTBMF) II of FO-UFRGS for the removal of included lower third molars will be conducted. Before and after the surgeries, the facial and mouth opening measurements of all patients will be done. Immediately after the surgeries, the patients will be randomized by means of envelopes in two groups. In the LED group the patients will receive daily LED applications (intra oral with 660nm and extra oral with 850nm) from the immediate postoperative to 7 days after the surgical procedure. In the control group the patients will be treated in the same way as in the LED group, however, the person in charge of the application will simulate intraoral and extraoral irradiation with the LED kept off. Pain (EVA and NRS-101), postoperative edema, trismus, temperature, dysphagia and hematomas, as well as the impact of the surgical procedure on patients' quality of life will be evaluated after 1, 2, 5 and 7 days. For the analysis of the oral health impact profile (OHIP-14 Questionnaire) and anxiety analysis (Beck anxiety inventory -BAI) the questionnaires will be applied preoperatively and 7 days after treatment. Initial descriptive analyzes will be performed considering all variables measured in the study, both quantitative (mean and standard deviation) and qualitative (frequencies and percentages). Later, the appropriate statistical tests will be applied for each specific analysis. In all tests, the significance level of 5% probability or the corresponding p-value will be adopted. All analyzes will be performed using the statistical software SAS for Windows, version 9.1.3.
- Conditions
- Pain, Postoperative, Edema, Trismus, Quality of Life
- Being tested
- LED group, Sham group
- Medical subject headings
- Pain, Postoperative, Edema, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED groupRadiation
The patients (n=17) will receive daily intra and extra oral LED applications from the immediate postoperative period up to 7 days after the surgical procedure. The LED irradiation will be performed in two areas, one intra and one extra oral. The LED to be used in the intraoral site will be red, 660+/-20nm wavelength, 5 mW power, 2.7J/cm2 energy density for 7 min, 2J energy per point, knowing that the 6 irradiated spots will have 12J in total. In the extra oral site the infra-red LED will be used, 850+/-20nm wavelength, power of 5mW, 3.8J/cm2 of energy density for 10 min, 3J of energy per point, knowing that 36 will be irradiated, so we will have 108J in total.
Sham groupRadiation
Patients will be treated in the same way as the LED group. The person in charge of the application will simulate the intraoral and extraoral irradiation by positioning the LED in the same locations described for the LED group, but the equipment will be kept off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of application.
| Study group | Role | What they receive |
|---|---|---|
| LED group | Active comparator | The patients (n=17) will receive daily intra and extra oral LED applications from the immediate postoperative period up to 7 days after the surgical procedure. The LED irradiation will be performed in two areas, one intra and one extra oral. The LED to be used in the intraoral site will be red, 660+/-20nm wavelength, 5 mW power, 2.7J/cm2 energy density for 7 min, 2J energy per point, knowing that the 6 irradiated spots will have 12J in total. In the extra oral site the infra-red LED will be used, 850+/-20nm wavelength, power of 5mW, 3.8J/cm2 of energy density for 10 min, 3J of energy per point, knowing that 36 will be irradiated, so we will have 108J in total. Receives: Radiation: LED group |
| Sham group | Sham comparator | Patients (n=17) will be treated in the same way as the LED group. The person in charge of the application will simulate the intraoral and extraoral irradiation by positioning the LED in the same locations described for the LED group, but the equipment will be kept off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of application. Receives: Radiation: Sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postoperative pain
A Visual Analog Scale (VAS) will be printed on the patient evaluation form and the subjects will be instructed by the evaluator to mark a point in the line of 10 cm, indicating the intensity of their pain after 1,2, 5 and 7 days of the surgeries.
Measured: After 1, 2, 5 and 7 days of surgeries.
Secondary outcomes (4)
Changes of postoperative edema
The evaluator will measure the distances between the corner of the eye and angle of the mandible, between the tragus and labial commissure and between the tragus and pogonium.
Measured: After 1, 2, 5 and 7 days of surgeries.
Change of trismus
The evaluator will measure the opening of the mouth using a pachymeter in each patient 1, 2, 5 and 7 days after surgery.
Measured: After 1, 2, 5 and 7 days of surgeries.
Changes in quality of life
The Oral Health Impact Profile (OHIP-14) is a simplified form of the original OHIP questionnaire that is used to assess the impact of oral health on subjects' quality of life. The items are distributed among the following subscales: functional limitation, pain, psychological discomfort, physical disability, psychological deficiency, social incapacity and disability. The questionnaire will be applied by the evaluator.
Measured: Before and 7 days after surgery.
Changes in postoperative pain (NRS-10 scale)
For the NRS-101 scale, the evaluators will ask patients to assign a number between 0 (no pain) and 100 (worst possible pain) that best represents the pain they are currently experiencing after 1, 2, 5 and 7 days of surgeries.
Measured: After 1, 2, 5 and 7 days of surgeries.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Sep 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442166
- Sponsor's protocol ID
- Carlos
- Status last verified
- Oct 2018
- First submitted
- 9 Feb 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Trial on the Effectiveness of Light-emitting Diode (LED) Photobiomodulation in Pain Management, Facial Edema, Trismus and Quality of Life After Extraction of Retained Lower Third Molars
- ClinicalTrials.gov ID
- NCT03442166
- Acronym / sponsor ID
- Carlos
- Conditions
- Pain, Postoperative, Edema, Trismus, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 22 Feb 2018 (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.
In dentistry, one of the most common surgical procedures is the removal of included third molars. This surgery generates great morbidity to patients for causing pain, edema and trismus due to surgical trauma. The use of photobiomodulation (PBM) (low-power laser or light emitting diode - LED) in the postoperative of these procedures has shown excellent results in the control of postoperative sequelae. The objective of the present study is to evaluate the effectiveness of PBM with LED in the control of pain, facial edema, trismus and quality of life resulting from the extraction of retained lower third molars. A randomized, double-blind, placebo-controlled clinical trial involving 34 adult patients, who search the Discipline of Buccomaxillofacial Surgery and Traumatology (CTBMF) II of FO-UFRGS for the removal of included lower third molars will be conducted. Before and after the surgeries, the facial and mouth opening measurements of all patients will be done. Immediately after the surgeries, the patients will be randomized by means of envelopes in two groups. In the LED group the patients will receive daily LED applications (intra oral with 660nm and extra oral with 850nm) from the immediate postoperative to 7 days after the surgical procedure. In the control group the patients will be treated in the same way as in the LED group, however, the person in charge of the application will simulate intraoral and extraoral irradiation with the LED kept off. Pain (EVA and NRS-101), postoperative edema, trismus, temperature, dysphagia and hematomas, as well as the impact of the surgical procedure on patients' quality of life will be evaluated after 1, 2, 5 and 7 days. For the analysis of the oral health impact profile (OHIP-14 Questionnaire) and anxiety analysis (Beck anxiety inventory -BAI) the questionnaires will be applied preoperatively and 7 days after treatment. Initial descriptive analyzes will be performed considering all variables measured in the study, both quantitative (mean and standard deviation) and qualitative (frequencies and percentages). Later, the appropriate statistical tests will be applied for each specific analysis. In all tests, the significance level of 5% probability or the corresponding p-value will be adopted. All analyzes will be performed using the statistical software SAS for Windows, version 9.1.3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LED group | Active comparator | Radiation: LED groupThe patients (n=17) will receive daily intra and extra oral LED applications from the immediate postoperative period up to 7 days after the surgical procedure. The LED irradiation will be performed in two areas, one intra and one extra oral. The LED to be used in the intraoral site will be red, 660+/-20nm wavelength, 5 mW power, 2.7J/cm2 energy density for 7 min, 2J energy per point, knowing that the 6 irradiated spots will have 12J in total. In the extra oral site the infra-red LED will be used, 850+/-20nm wavelength, power of 5mW, 3.8J/cm2 of energy density for 10 min, 3J of energy per point, knowing that 36 will be irradiated, so we will have 108J in total. |
| Sham group | Sham comparator | Radiation: Sham groupPatients (n=17) will be treated in the same way as the LED group. The person in charge of the application will simulate the intraoral and extraoral irradiation by positioning the LED in the same locations described for the LED group, but the equipment will be kept off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of application. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who need surgical removal of retained lower third molars;
- Patients who agree to participate in the study after reading and signing the Term of Consent for Participation in Clinical Research.
- Patients with indication for extraction of lower third molars (recurrent infections, bad position, orthodontic indication) or written professional indication (ASA I - negative medical history), systolic blood pressure less than 140mmHg, and diastolic blood pressure lower than 90mmHg and heart rate values of 70 ± 20 beats / minute and have the upper and lower central incisor teeth.
Key exclusion criteria (11 listed)
- Patients who have systemic diseases, chronic pain or neurological and psychiatric disorders;
- Claim to be smokers;
- Are using anti-inflammatories, analgesics or bisphosphonates in the last 15 days;
- Present active pericoronaritis;
- Are pregnant;
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 |
|---|---|---|
| LED groupThe patients (n=17) will receive daily intra and extra oral LED applications from the immediate postoperative period up to 7 days after the surgical procedure. The LED irradiation will be performed in two areas, one intra and one extra oral. The LED to be used in the intraoral site will be red, 660+/-20nm wavelength, 5 mW power, 2.7J/cm2 energy density for 7 min, 2J energy per point, knowing that the 6 irradiated spots will have 12J in total. In the extra oral site the infra-red LED will be used, 850+/-20nm wavelength, power of 5mW, 3.8J/cm2 of energy density for 10 min, 3J of energy per point, knowing that 36 will be irradiated, so we will have 108J in total. | Radiation | LED group |
| Sham groupPatients will be treated in the same way as the LED group. The person in charge of the application will simulate the intraoral and extraoral irradiation by positioning the LED in the same locations described for the LED group, but the equipment will be kept off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of application. | Radiation | Sham group |
Primary outcome
Changes in postoperative pain
Time frame: After 1, 2, 5 and 7 days of surgeries.
A Visual Analog Scale (VAS) will be printed on the patient evaluation form and the subjects will be instructed by the evaluator to mark a point in the line of 10 cm, indicating the intensity of their pain after 1,2, 5 and 7 days of the surgeries.
4 secondary outcomes
Changes of postoperative edema
Time frame: After 1, 2, 5 and 7 days of surgeries.
Change of trismus
Time frame: After 1, 2, 5 and 7 days of surgeries.
Changes in quality of life
Time frame: Before and 7 days after surgery.
Changes in postoperative pain (NRS-10 scale)
Time frame: After 1, 2, 5 and 7 days of surgeries.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LED group in people with Pain, Postoperative and Edema, run by University of Nove de Julho at 1 site in Brazil.
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 11 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 11 Oct 2018. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in postoperative pain (time frame: After 1, 2, 5 and 7 days of surgeries.). 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 11 Oct 2018.