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Laser Therapy, Low-LevelNCT03164252

Low Power Laser in Mandibular Third Molar Surgery

A study testing Grupo I- Lower laser fluency and Grupo II- Greater laser fluency in people with Laser Therapy, Low-Level, run by Universidade Estadual Paulista Júlio de Mesquita Filho.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The low-power laser provides the body with an improvement in the inflammatory response. Thus, the objective of this study is to evaluate two laser application protocols in 60 patients requiring surgical treatment for extraction of third molars included, without distinction of race or gender, aged between 16 and 40… Read more about this study

Who is it for?
Ages 16 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Laser Therapy, Low-Level
What is being tested?
Grupo I- Lower laser fluency and Grupo II- Greater laser fluency
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7 participants
Where
No sites listed yet
Study dates
23 Feb 2016to 6 Dec 2016
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 16 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy patients, without surgical contraindications, requiring avulsion of the included third molars and / or impacted lower molars,
  • Teeth classified according to Winter (1926) as mesioangulated and according to Pell \& Gregory (1933) as 1A to 2B.
  • Between the ages of 16 and 40
  • Who have agreed to participate in the research voluntarily, after knowing the risks and benefits, and signed the Informed Consent Term (TCLE)

Who cannot join

  • Patients with any systemic or local change that contraindicate the procedure,
  • Use of anti-inflammatories in the last 15 days,
  • Patients smokers or diabetics.

About this study

Official title: Low Power Laser in the Second Molar Tissue Repair and in the Postoperative of Mandibular Third Molar Surgery - Double Blind Randomized Clinical Trial.

The low-power laser provides the body with an improvement in the inflammatory response. Thus, the objective of this study is to evaluate two laser application protocols in 60 patients requiring surgical treatment for extraction of third molars included, without distinction of race or gender, aged between 16 and 40 years, coming from the Faculty of Dentistry Of São José dos Campos (UNESP). These patients will be divided randomly into 3 groups: group 1 - intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2) , group 2 - intraoral irradiation with 660 nm laser at a dose of 30 J (30 mW, 30 J / cm 2) and group 3- control group, with application of placebo laser. At 3 and 7 days after surgery, the patients will be evaluated by two evaluators who will measure edema, trismus and pain. The tissue repair will also be evaluated after 1, 3 and 6 months of surgery, through radiographic analysis and periodontal conditions in the distal of the lower second molar. The results will be submitted to descriptive statistics and compared using the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.

Read the detailed description

Knowing the ability of the low-power laser to provide the body with an improvement in inflammatory response, with consequent reduction of edema, minimizing painful symptoms and leading to biostimulation, laser therapy is presented as an alternative for processes that present an inflammatory reaction, Pain and need for tissue regeneration. The literature shows the efficacy of laser in the postoperative surgery for extraction of third molars. However, to date, there is no consensus on the best protocol to be used in these cases. Thus, the objective of this study will be to evaluate two laser application protocols. To this end, 60 patients will be selected who require surgical treatment for the extraction of third molars, regardless of race or gender, between the ages of 16 and 40, from the School of Dentistry of São José dos Campos (UNESP). These patients will be divided randomly into 3 groups: group 1 - intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2), group 2 - intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2) and group 3 - control group, with application of placebo laser. At 3 and 7 days after surgery, patients will be evaluated by two evaluators who will measure edema, mouth opening (assessment of muscle spasm) and pain. To compare the data, we will use the analog pain scale (VAS), the method of Ustün et al. (2003), and the millimeter rule. The patient will also be questioned about possible postoperative problems, as well as the surgeon, who will classify the postoperative repair process according to Batinjan et al. (2013). The tissue repair will also be evaluated after 1, 3 and 6 months of surgery, through radiographic analysis and periodontal conditions in the distal of the lower second molar. The results will be submitted to descriptive statistics and compared using the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.

Being tested
Grupo I- Lower laser fluency, Grupo II- Greater laser fluency, Grupo III- Laser sham
Keywords
Third molar;, Third molar surgery;, Laser;, Tissue Repair.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Grupo I- Lower laser fluencyRadiation

    Also called Red laser diode of 660 nm/ power 30 mW/ creep of 10 J / cm2

    The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.

  • Grupo II- Greater laser fluencyRadiation

    Also called Red laser diode of 660 nm/ power 30 mW/ creep of 30 J / cm2.

    The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.

  • Grupo III- Laser shamRadiation

    Also called Control group, application of laser sham

    The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.

Study groups in NCT03164252
Study groupRoleWhat they receive
Grupo I- Lower laser fluencyActive comparator20 patients received 660 nm red laser diode laser therapy, 30 mW power and 10 J / cm2 fluency, in the immediate period after surgical period of the third molar third molar extraction / impacted by the intraoral region
Receives: Radiation: Grupo II- Greater laser fluency; Radiation: Grupo III- Laser sham
Grupo II- Greater laser fluencyActive comparator20 patients received 660 nm red laser diode laser therapy, 30 mW power and 30J / cm2 fluency, in the immediate period after surgical of the third molar third molar extraction / impacted by the intraoral region
Receives: Radiation: Grupo I- Lower laser fluency; Radiation: Grupo III- Laser sham
Grupo III- Laser shamPlacebo comparatorApplication of laser sham, the handpiece of the device will be positioned intraorally and activated. However, the tip of the applicator will be covered by an opaque material that prevents radiation from passing through.
Receives: Radiation: Grupo I- Lower laser fluency; Radiation: Grupo II- Greater laser fluency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Periodontal probing

    Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). For the investigator periodontal evaluation was performed based on the modified Montero \& Mazzaglia (2011) methodology, where the length of the clinical crown in the second distal molar region will be measured with a North Carolina-type probe (Hu-Friedy, Chicago, USA). According to this methodology, we will previously mold the occlusal of the second molar with a condensation silicone (Optosil Xantopren, Heraeus Kulzer, Hanau, Germany), which was used as a guide to standardize the location and height of the measurement. We will then measure at three points in the distal of the second molar: disto-lingual, mesio-distal and vestibular-distal.

    Measured: Initially carried out in one, three and six months

Secondary outcomes (4)
  1. Pain assessment

    Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham).The investigators were based on the analogue pain scale (VAS).

    Measured: Evaluated immediately, two, four, six and eight hours after surgery. And with continuity for one, two, three and four days

  2. Edema assessment

    Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). For investigators to measure facial edema used the method of Ustün et al. (2003) and a millimeter rule to obtain the measures.

    Measured: Initially carried out in three and seven days.

  3. Trismus assessment

    Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). To measure the buccal opening, the distance between the incisal edges of the maxillary and mandibular incisors, obtained with the patient sitting upright, will be evaluated by a millimeter ruler.

    Measured: Initially carried out in three and seven days

  4. Radiographic assessment

    Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). Radiographic evaluation will be performed using the methodology as recommended by Ogundipe et al. (2011), who performed periapical radiographs of the investigators region and classified the bone repair based on three variables: hard blade, bone density and trabecular pattern according to a specific table.

    Measured: Assessment in one, three and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2017
  2. Study start23 Feb 2016
  3. Primary completion7 Jun 2016
  4. Study completion6 Dec 2016

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The sample of this study will be composed of 60 patients between 16 and 40 years old, who need to undergo the extraction of third molars included and / or impacted. The patients will be those who voluntarily seek the Discipline of Buccomaxillofacial Surgery and Traumatology, at the State University of São Paulo "Júlio de Mesquita Filho" - Unesp, to perform the procedure. This study will be a randomized, double-blind, prospective clinical trial with the following groups: Group I (with 20 patients) - laser therapy used in the immediate postoperative period will be intraoral irradiation with 660 nm red diode laser, 30 mW power and 10 J / cm2 fluency. Group II (with 20 patients) - laser therapy used in the immediate postoperative period will be intraoral irradiation with 660 nm red diode laser, 30 mW power and 30 J / cm2 fluency. Group III (with 20 patients) - Control Group - Application of laser sham.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03164252
Sponsor's protocol ID
47325515.3.0000.0077
Status last verified
Jun 2018
First submitted
18 May 2017
Last updated
18 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lago-Mendez L, Diniz-Freitas M, Senra-Rivera C, Gude-Sampedro F, Gandara Rey JM, Garcia-Garcia A. Relationships between surgical difficulty and postoperative pain in lower third molar extractions. J Oral Maxillofac Surg. 2007 May;65(5):979-83. doi: 10.1016/j.joms.2006.06.281.

    PubMed 17448851
  • Lopez-Ramirez M, Vilchez-Perez MA, Gargallo-Albiol J, Arnabat-Dominguez J, Gay-Escoda C. Efficacy of low-level laser therapy in the management of pain, facial swelling, and postoperative trismus after a lower third molar extraction. A preliminary study. Lasers Med Sci. 2012 May;27(3):559-66. doi: 10.1007/s10103-011-0936-8. Epub 2011 May 27.

    PubMed 21617973
  • Montero J, Mazzaglia G. Effect of removing an impacted mandibular third molar on the periodontal status of the mandibular second molar. J Oral Maxillofac Surg. 2011 Nov;69(11):2691-7. doi: 10.1016/j.joms.2011.06.205. Epub 2011 Aug 23.

    PubMed 21864969

Questions about this trial

What is this clinical trial studying?

A study testing Grupo I- Lower laser fluency and Grupo II- Greater laser fluency in people with Laser Therapy, Low-Level, run by Universidade Estadual Paulista Júlio de Mesquita Filho.

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 4 inclusion and 3 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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Periodontal probing (time frame: Initially carried out in one, three and six months). 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 NCT03164252, which also lists 3 linked publications.

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 18 Jun 2018.

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