Maxillary DiseasesPhase 2NCT03814525
Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction
A Phase 2 study testing Photobiomodulation in people with Maxillary Diseases, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The objective of the present study will be to evaluate the efficacy of photobiomodulation (PBM) with LED in pain control, facial edema, paresthesia, bone repair and quality of life arising after maxillar surgical disjunction (MSD). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Diseases
- What is being tested?
- Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2019to 28 Feb 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Transverse maxillary deficiency ˃ of 5 mm with bilateral posterior crossbite and indication for surgical maxillary disjunction.
- Agree to participate in the study after reading and signing the Term of Consent for Participation in Clinical Research.
Who cannot join
- Transverse maxilla deficiency, with unilateral posterior crossbite.
- Local or systemic alterations that contraindicate surgical intervention or hinder the postoperative period.
- Smokers.
- Display photo sensitivity history.
- Possess systemic diseases, chronic pain or neurological and psychiatric disorders.
- Have been using anti-inflammatories, analgesics or bisphosphonates in the past 15 days.
Show all 9Show fewer
- Pregnant.
- Breastfeeding.
- Participants who present any type of complication during surgery (hemorrhage, operative difficulty), as these cases will not be in the expected pattern for these surgeries. 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
Conjunto Hospitalar do Mandaqui
São Paulo, São Paulo, 02402-500
Sandra K Bussadori, PhD, +55112281-5000, sandra.skb@gmail.com
About this study
Official title: Evaluation of Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction: Double Blind, Randomized and Controlled Clinical Trial
The objective of the present study will be to evaluate the efficacy of photobiomodulation (PBM) with LED in pain control, facial edema, paresthesia, bone repair and quality of life arising after maxillar surgical disjunction (MSD). A randomized, double-blind, placebo-controlled clinical trial involving 72 participants aged 18 to 45 years, who search the Service of Oral Maxillofacial Surgery and Traumatology of the Mandaqui Hospital Complex to undergo MSD, attend to the eligibility criteria and agree to participate. Surgeries will be conducted by three oral maxillofacial surgeons who will perform all surgical procedures, two examiners (who will perform pre and post-surgical evaluations, blinded to the experimental group) and another researcher who will perform the LED application. Before the surgeries, facial measures, radiographic examinations, tests of facial and oral sensitivity and the evaluation of the level of anxiety of all the participants will be carried out. Immediately after the surgeries, the participant will be inserted into the placebo group or the LED group, according to block randomization defined previously. In the LED group, the participants will receive PBM with an extraoral device (660 and 850 nm with 6J per point) and an intraoral one (660 nm with 2J per point) and in the control group the participants will be attended in the same way, but with the LED devices kept off. The applications will be in the immediate postoperative period, 1, 2, 7, 14, 30, 60, 90 and 120 days after the end of the surgeries, when the evaluations will also be performed. Facial measurements, extra and intraoral sensitivity, pain and bone repair will be evaluated. Secondarily, the data regarding the occurrence of headache; otalgia; nausea; bruise; nasolacrimation; epistaxis; dysphagia; systemic and superficial temperature in the operated region; use of analgesics and anti-inflammatories; anxiety and impact of oral health on the participants' quality of life will be computed.
- Conditions
- Maxillary Diseases
- Being tested
- Photobiomodulation, Placebo Photobiomodulation
- Medical subject headings
- Maxillary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationRadiation
PBM will be applied with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days.
Placebo PhotobiomodulationRadiation
The person responsible for applying the PBM will simulate the irradiation by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation group | Active comparator | PBM will be applied after the surgeries with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days. Receives: Radiation: Photobiomodulation |
| Control group | Placebo comparator | Participants will be attended in the same way as the PBM group. The person who is responsible for the application of the PMB will simulate the irradiations by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off. Receives: Radiation: Placebo Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 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, 7 and 14 days of the surgeries. 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, 7 and 14 days of surgeries.
Measured: After 1, 2, 7 and 14 days of surgeries.
Change in Edema
Using a flexible plastic millimeter tape (0.5mm precision), five facial measurements will be taken corresponding to the distances between the points listed below as described by Ristow et al. (2013).
Line A - posterior tragus point to the most lateral point of the labial commissure Line B - tragus posterior point to pogonium Line C - posterior tragus point to the lateral corner of the eye Line D - lateral corner of eye to lowest point of jaw angle Line E - lower point of the angle of the mandible (gonio) to the middle of the nasal bone
Measured: After 1, 2, 7 and 14 days of surgeries.
Change in intra and extraoral sensitivity
The evaluation of extra and intraoral sensitivity will be performed in 6 regions: below the lower eyelid, cheek, nose wing, upper lip, oral buccal mucosa and oral palatal mucosa on both sides. The tests will be performed sequentially, with a 2 to 3 minute interval between each. The participant will receive instructions on the tests that will be initially performed on the back of his hand so he can become familiar.
Measured: After 7, 30, 60, 90 and 120 days of surgeries.
Change in postoperative bone repair
The optical density (OD) of the alveolar bone in the anterior region of the palatine suture, in each experimental period, will be calculated and compared with that obtained in the preoperative radiographic examination.
Measured: After 30, 60, 90 and 120 days of surgeries.
Secondary outcomes (9)
Change in temperature
The temperature will be measured locally (on both sides) and systemically. Local measurements will be measured using an infrared digital thermometer in the right and left cheek region and anterior nasal spine. The systemic temperature will be measured in the frontal region of the patient in the median position 3 cm above the glabella.
Measured: After 1, 2, 7 and 14 days of surgeries.
Presence of headache
Patients will answer yes or not, to indicate whether they had headaches in the examined periods.
Measured: After 1, 2, 7 and 14 days of surgeries.
Presence of bruises
The presence of hematoma/ecchymosis will be evaluated by measuring the largest diameter of the colorimetric changes on the right and left side. The measure will be performed by the examiners who will classify the occurrence of this result into four categories: 1) none; 2) larger diameter smaller than 4 cm; 3) larger diameter between 4 and 10 cm, and 4) larger diameter greater than 10 cm.
Measured: After 1, 2, 7 and 14 days of surgeries.
Presence of otalgia
Patients will answer yes or not, to indicate whether they had otalgia in the examined periods.
Measured: After 1, 2, 7 and 14 days of surgeries.
Presence of nausea
Patients will answer yes or not, to indicate whether they had nausea in the examined periods.
Measured: After 1, 2, 7 and 14 days of surgeries.
Presence of nasolacrimation
Patients will answer yes or not, to indicate whether they had nasolacrimation in the examined periods.
Measured: After 1, 2, 7 and 14 days of surgeries.
Presence of nose bleeding
Patients will answer yes or not, to indicate whether they had nose bleeding in the examined periods.
Measured: After 1, 2, 7 and 14 days of surgeries.
Presence of dysphagia
The evaluation of dysphagia will be performed after 7 and 30 days by questioning and classification on a numerical scale in which:
(0) total absence of dysphagia;
- dysphagia to solid foods
- dysphagia to any liquid or solid food
Measured: After 7 and 30 days of surgeries.
Postoperative quality of life
Patients will answer yes or no to the following questions:
- Are you maintaining your social activities normally?
- Are you working / studying normally?
- Are you maintaining your normal diet?
- Do you have difficulty swallowing because of the surgery?
- Do you have difficulty in tasting food?
- Can you chew on the sides?
- Do you have trouble sleeping because of the surgery?
- Did you have trouble speaking because of the surgery?
- Has your appearance changed because of the surgery?
- Do you feel sick from the surgery?
Measured: After 7 and 30 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 posted24 Jan 2019
- Study start2 Jan 2019
- Primary completion30 Jan 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary DiseasesStudies 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, Outcomes assessor
- Enrolment
- 72 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
- NCT03814525
- Sponsor's protocol ID
- Eduardo
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
da Fonseca EV, Bussadori SK, da Silva Martinho LFC, de Sousa Melo MC, de Andrade FL, Goncalves MLL, Mesquita-Ferrari RA, Horliana ACRT, Fernandes KPS. Evaluation of photobiomodulation effects on pain, edema, paresthesia, and bone regeneration after surgically assisted rapid maxillary expansion: Study protocol for a randomized, controlled, and double blind clinical trial. Medicine (Baltimore). 2019 Nov;98(48):e17756. doi: 10.1097/MD.0000000000017756.
PubMed 31770194
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction: Double Blind, Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03814525
- Acronym / sponsor ID
- Eduardo
- Conditions
- Maxillary Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 24 Jan 2019 (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 objective of the present study will be to evaluate the efficacy of photobiomodulation (PBM) with LED in pain control, facial edema, paresthesia, bone repair and quality of life arising after maxillar surgical disjunction (MSD). A randomized, double-blind, placebo-controlled clinical trial involving 72 participants aged 18 to 45 years, who search the Service of Oral Maxillofacial Surgery and Traumatology of the Mandaqui Hospital Complex to undergo MSD, attend to the eligibility criteria and agree to participate. Surgeries will be conducted by three oral maxillofacial surgeons who will perform all surgical procedures, two examiners (who will perform pre and post-surgical evaluations, blinded to the experimental group) and another researcher who will perform the LED application. Before the surgeries, facial measures, radiographic examinations, tests of facial and oral sensitivity and the evaluation of the level of anxiety of all the participants will be carried out. Immediately after the surgeries, the participant will be inserted into the placebo group or the LED group, according to block randomization defined previously. In the LED group, the participants will receive PBM with an extraoral device (660 and 850 nm with 6J per point) and an intraoral one (660 nm with 2J per point) and in the control group the participants will be attended in the same way, but with the LED devices kept off. The applications will be in the immediate postoperative period, 1, 2, 7, 14, 30, 60, 90 and 120 days after the end of the surgeries, when the evaluations will also be performed. Facial measurements, extra and intraoral sensitivity, pain and bone repair will be evaluated. Secondarily, the data regarding the occurrence of headache; otalgia; nausea; bruise; nasolacrimation; epistaxis; dysphagia; systemic and superficial temperature in the operated region; use of analgesics and anti-inflammatories; anxiety and impact of oral health on the participants' quality of life will be computed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group | Active comparator | Radiation: PhotobiomodulationPBM will be applied after the surgeries with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days. |
| Control group | Placebo comparator | Radiation: Placebo PhotobiomodulationParticipants will be attended in the same way as the PBM group. The person who is responsible for the application of the PMB will simulate the irradiations by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Transverse maxillary deficiency ˃ of 5 mm with bilateral posterior crossbite and indication for surgical maxillary disjunction.
- Agree to participate in the study after reading and signing the Term of Consent for Participation in Clinical Research.
Key exclusion criteria (9 listed)
- Transverse maxilla deficiency, with unilateral posterior crossbite.
- Local or systemic alterations that contraindicate surgical intervention or hinder the postoperative period.
- Smokers.
- Display photo sensitivity history.
- Possess systemic diseases, chronic pain or neurological and psychiatric disorders.
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 |
|---|---|---|
| PhotobiomodulationPBM will be applied with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days. | Radiation | Photobiomodulation group |
| Placebo PhotobiomodulationThe person responsible for applying the PBM will simulate the irradiation by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off | Radiation | Control group |
Primary outcome
Change in Pain
Time frame: After 1, 2, 7 and 14 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, 7 and 14 days of the surgeries. 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, 7 and 14 days of surgeries.
Change in Edema
Time frame: After 1, 2, 7 and 14 days of surgeries.
Using a flexible plastic millimeter tape (0.5mm precision), five facial measurements will be taken corresponding to the distances between the points listed below as described by Ristow et al. (2013). Line A - posterior tragus point to the most lateral point of the labial commissure Line B - tragus posterior point to pogonium Line C - posterior tragus point to the lateral corner of the eye Line D - lateral corner of eye to lowest point of jaw angle Line E - lower point of the angle of the mandible (gonio) to the middle of the nasal bone
Change in intra and extraoral sensitivity
Time frame: After 7, 30, 60, 90 and 120 days of surgeries.
The evaluation of extra and intraoral sensitivity will be performed in 6 regions: below the lower eyelid, cheek, nose wing, upper lip, oral buccal mucosa and oral palatal mucosa on both sides. The tests will be performed sequentially, with a 2 to 3 minute interval between each. The participant will receive instructions on the tests that will be initially performed on the back of his hand so he can become familiar.
Change in postoperative bone repair
Time frame: After 30, 60, 90 and 120 days of surgeries.
The optical density (OD) of the alveolar bone in the anterior region of the palatine suture, in each experimental period, will be calculated and compared with that obtained in the preoperative radiographic examination.
9 secondary outcomes
Change in temperature
Time frame: After 1, 2, 7 and 14 days of surgeries.
Presence of headache
Time frame: After 1, 2, 7 and 14 days of surgeries.
Presence of bruises
Time frame: After 1, 2, 7 and 14 days of surgeries.
Presence of otalgia
Time frame: After 1, 2, 7 and 14 days of surgeries.
Presence of nausea
Time frame: After 1, 2, 7 and 14 days of surgeries.
Presence of nasolacrimation
Time frame: After 1, 2, 7 and 14 days of surgeries.
Presence of nose bleeding
Time frame: After 1, 2, 7 and 14 days of surgeries.
Presence of dysphagia
Time frame: After 7 and 30 days of surgeries.
Postoperative quality of life
Time frame: After 7 and 30 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 24 Jan 2019.
- Derived from this study: PubMed 31770194da Fonseca EV, Bussadori SK, da Silva Martinho LFC, de Sousa Melo MC, de Andrade FL, Goncalves MLL, Mesquita-Ferrari RA, Horliana ACRT, Fernandes KPS. Evaluation of photobiomodulation effects on pain, edema, paresthesia, and bone regeneration after surgically assisted rapid maxillary expansion: Study protocol for a randomized, controlled, and double blind clinical trial. Medicine (Baltimore). 2019 Nov;98(48):e17756. doi: 10.1097/MD.0000000000017756.
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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 Photobiomodulation in people with Maxillary Diseases, 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 2 inclusion and 9 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 24 Jan 2019. 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?
Change in Pain (time frame: After 1, 2, 7 and 14 days of surgeries.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03814525, which also lists 1 linked publication.
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 24 Jan 2019.