Photobiomodulation on Molar Verticalization With Mini-implant

NCT ID: NCT04036539

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2021-12-30

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.

Conditions

Orthodontic Appliances; Low-Level Light Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control (placebo)

Patients in Control will receive the photobiomodulation placebo,application, but with the laser off. Procedures will be performed immediately after the application of forces (placement of elastic bandages) on the tooth, as described: Simulations will be performed with the same laser.This will require 10 seconds of application simulation per point. As 10 points will be simulated, it will take 100 seconds for this simulation.5 points lingual and 5 points at vestibular

Group Type: PLACEBO_COMPARATOR

Placement of the mini-implant and verticalization

Intervention Type: PROCEDURE

an orthodontic mini-implant will be installed in the retromandibular region. The site will be anesthetized. The region will be pre-drilled by about 5mm with a spear drill attached to an implant motor. Once the mini-implant has been selected, it will be locked into position using a kit-specific digital key. Being threaded clockwise until the intramucosal mini-implant is at the gingival level. After installation, a metallic orthodontic lingual will be glued to the molar mesial to be verticalized. The lingual button will be glued to the inclined molar mesial with orthodontic adhesive. A gray chain elastomeric ligature will attach the head of the mini-implant to the lingual button glued to the molar mesial. A light force of 150gr will be imposed (measured with a tensiometer) in all cases, regardless of tooth position. This chain elastic will be changed every 30 days for a period of 3 months. After 90 days of the experiment time, the mini-implants will be removed.

Experimental:

Experimental: Molar verticalization + PBM (n = 17 + 3) - patients will receive laser treatment (photobiomodulation) in order to modulate orthodontic movement and act on inflammation and pain. The procedures will be performed immediately after the application of forces (placement of elastic bandages) on the tooth, as described:The irradiations will be performed with the red diode laser ( = 660 nm) with 100 milliwatts output power The power of the device will be 100miliWatts and the wavelength used will be 808 nanometers (± 10nm). The optical fiber diameter of the device is 600 micrometer, therefore a spot (area) of 0.002826 centimeter2. The energy delivered per point will be 1Joule. This will require 10 seconds of application per point. As 10 points will be irradiated, the total application time will be 100 seconds and the total energy delivered will be 10Joule. The energy density will be 25 Joule / cm2 and the power density will be 35.38 Watt / cm2

Group Type: EXPERIMENTAL

Placement of the mini-implant and verticalization

Intervention Type: PROCEDURE

an orthodontic mini-implant will be installed in the retromandibular region. The site will be anesthetized. The region will be pre-drilled by about 5mm with a spear drill attached to an implant motor. Once the mini-implant has been selected, it will be locked into position using a kit-specific digital key. Being threaded clockwise until the intramucosal mini-implant is at the gingival level. After installation, a metallic orthodontic lingual will be glued to the molar mesial to be verticalized. The lingual button will be glued to the inclined molar mesial with orthodontic adhesive. A gray chain elastomeric ligature will attach the head of the mini-implant to the lingual button glued to the molar mesial. A light force of 150gr will be imposed (measured with a tensiometer) in all cases, regardless of tooth position. This chain elastic will be changed every 30 days for a period of 3 months. After 90 days of the experiment time, the mini-implants will be removed.

Interventions

Placement of the mini-implant and verticalization

an orthodontic mini-implant will be installed in the retromandibular region. The site will be anesthetized. The region will be pre-drilled by about 5mm with a spear drill attached to an implant motor. Once the mini-implant has been selected, it will be locked into position using a kit-specific digital key. Being threaded clockwise until the intramucosal mini-implant is at the gingival level. After installation, a metallic orthodontic lingual will be glued to the molar mesial to be verticalized. The lingual button will be glued to the inclined molar mesial with orthodontic adhesive. A gray chain elastomeric ligature will attach the head of the mini-implant to the lingual button glued to the molar mesial. A light force of 150gr will be imposed (measured with a tensiometer) in all cases, regardless of tooth position. This chain elastic will be changed every 30 days for a period of 3 months. After 90 days of the experiment time, the mini-implants will be removed.

Intervention Type: PROCEDURE

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®,

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Anna Carolina Ratto Tempestini Horliana

PhD, clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna carolina RT Horliana, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

Anna Carolina R.T. Horliana

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 31001928 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31027098 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22949122 (View on PubMed)

Other Identifiers

verticalization

Identifier Type: -

Identifier Source: org_study_id