Clinical trial NCT04036539: Photobiomodulation on Molar Verticalization With Mini-implant
Official title: Evaluation of the Effects of Photobiomodulation on Orthodontic Movement of Molar Verticalization With Mini-implant: a Randomized Double-blind Protocol Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliances
Low-Level Light Therapy
Keywords: orthodontic treatment,
photobiomodulation,
mini-implant,
verticalization of molars
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 34 individuals will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM.
Primary purpose: TREATMENT

Brief summary: The objective of this study will be to evaluate the effect of photobiomodulation on the acceleration of the orthodontic movement of molar verticalization and its effect on pain and inflammation of the periodontal tissues.

Thirty-four healthy patients aged 30-60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element, will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM (photobiomodulation) simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM. The movements will occur with the aid of mini-implants and elastomeric chains ligatures. The PBM will occur with diode laser application, 660 nm (nanometers), 100mW (milliwatts), receiving 1J(joule) per point, 10s (seconds), 10 points (5 per buccal and 5 per lingual) and radiant exposure of 25 J / cm². The crevicular gingival fluid (FGC) will be collected to analyzed Interleukins IL1β, IL-6, IL-8, IL-10(Interleukins) and TNF-α (tumor necrosis factor) by ELISA (enzyme-linked immunosorbent assay). Radiographic shots will be taken each month to ascertain the amount (in degrees) of verticalization. To evaluate the pain, the Visual Analogue Scale will be used in all the consultations, and to evaluate the quality of life, the OHIP-14 (oral health impact profile) questionnaire will be applied. Analgesics will be given and the number of drugs will be counted. If the data are normal, they will be submitted to the Student's t-test. The data will be presented as means ± SD(standard deviation) and the value of p will be defined as \<0.05.

Detailed description: Loss of a dental element can generate several repercussions in the stomatognathic system. According to the latest survey by the Ministry of Health, in 2010, Brazilian adults had, on average, 7 missing teeth. This loss may lead to movement of the adjacent teeth and the antagonist, which would make prosthetic rehabilitation harder to do. Anchoring systems, such as mini-implants, have been increasingly used as a treatment option because they act with heavy but controlled forces and without side effects. Recent studies have shown that photobiomodulation (PBM) can accelerate orthodontic movement in the molar intrusion. The objective of this study will be to evaluate the effect of photobiomodulation on the acceleration of the orthodontic movement of molar verticalization and its effect on pain and inflammation of the periodontal tissues.

Thirty-four healthy patients aged 30-60 years, who need to recover the prosthetic space for oral rehabilitation after loss of the posterior inferior dental elements and inclination of the adjacent element, will be randomly divided into 2 groups: G1 (control group) - verticalization by mini-implant + PBM simulation (placebo); G2 (experimental group) - verticalization by mini-implant + PBM. The movements will occur with the aid of mini-implants and elastomeric chains ligatures. The PBM will occur with diode laser application, 660 nm, 100mW, receiving 1J per point, 10s, 10 points (5 per buccal and 5 per lingual) and radiant exposure of 25 J / cm². The orthodontic forces of verticalization (corresponding to any exchange of elastomeric ligation) will be applied every 30 days and the PBM will be applied immediately, 3 and 7 days of each month, for a period of 3 months. The crevicular gingival fluid (FGC) will be collected on the 1st, 3rd and 7th days after the first activation, and then on the 3rd day of the following two months. Interleukins IL1β, IL-6, IL-8, IL-10 and TNF-α will be analyzed by ELISA. Radiographic shots will be taken each month to ascertain the amount (in degrees) of verticalization. To evaluate the pain, the Visual Analogue Scale will be used in all the consultations, and to evaluate the quality of life, the OHIP-14 questionnaire will be applied. Analgesics will be given and the number of drugs will be counted. If the data are normal, they will be submitted to the Student's t-test. The data will be presented as means ± SD and the value of p will be defined as \<0.05.

Eligibility criteria: Inclusion Criteria:

* Patients who agree and sign the informed consent
* healthy (ASA I - negative medical history),
* systolic blood pressure less than 140mmHg and diastolic blood pressure less than 90mmHg,
* heart rate with 70 ± 20 beats / minute
* requiring oral rehabilitation after loss of some posterior lower dental element (1st molar),
* with favorable periodontal condition to the installation of mini-implants. Any questions during the research period should be informed to the researcher so that the researcher can take the appropriate measures (the latter should provide some form of personal contact).

Exclusion Criteria:

* Patients who are latex allergic,
* pregnant or breastfeeding,
* smokers,
* diabetics,
* patients undergoing head and neck radiotherapy,
* coagulation disorders requiring antibiotic prophylaxis for placement of mini-implants, with absolute indication for use of local anesthetics with vasoconstrictors,
* with decompensated systemic disease,
* with systemic or local infection (periodontitis or periodontal abscess),
* who have used anti-inflammatory drugs in the last 3 months before orthodontic treatment.
* Patients who may have any complications during the research period, such as allergic reactions to any of the materials used, allergic reaction to paracetamol®,

Primary outcomes:
measure: Radiographic measurements
timeFrame: through study completion on average of one year
Secondary outcomes:
measure: Pain during movement: Visual Analog Scale (VAS)
timeFrame: through study completion on average of one year
measure: Assess the amount of painkillers ingested
timeFrame: through study completion on average of one year
measure: Oral health-related quality of life (HRQoL): OHIP-14
timeFrame: through study completion on average of one year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Anna Carolina R.T. Horliana
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Anna carolina RT Horliana, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandes MRU, Suzuki SS, Suzuki H, Martinez EF, Garcez AS. Photobiomodulation increases intrusion tooth movement and modulates IL-6, IL-8 and IL-1beta expression during orthodontically bone remodeling. J Biophotonics. 2019 Oct;12(10):e201800311. doi: 10.1002/jbio.201800311. Epub 2019 Jul 8.
citation: Schalch TO, Palmieri M, Longo PL, Braz-Silva PH, Tortamano IP, Michel-Crosato E, Mayer MPA, Jorge WA, Bussadori SK, Pavani C, Negreiros RM, Horliana ACRT. Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2019 Apr;98(17):e15312. doi: 10.1097/MD.0000000000015312.
citation: Bauer HC, Duarte FL, Horliana AC, Tortamano IP, Perez FE, Simone JL, Jorge WA. Assessment of preemptive analgesia with ibuprofen coadministered or not with dexamethasone in third molar surgery: a randomized double-blind controlled clinical trial. Oral Maxillofac Surg. 2013 Sep;17(3):165-71. doi: 10.1007/s10006-012-0360-7. Epub 2012 Sep 5.