Effects of Photobiomodulation in Burning Mouth Syndrome

NCT04034849 | Completed DMC

• 1 other identifier: 0003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to assess the effects of Photobiomodulation with Low-level Laser Therapy to the pain management in Burning Mouth Syndrome patients, besides assessing their impact on the different aspects of their quality of life, using the necessary questionnaires to evaluate all the outcomes of chronic pain.

Conditions

Burning Mouth Syndrome

Keywords

Low-level Laser Therapy; Burning Mouth Syndrome; Photobiomodulation; Visual Analogue Scale; Oral Health Impact Profile; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Changes in Visual Analogue Scale for Pain

  Pain was assessed using a Visual Analogue Scale (0-10 cm) by the patients before starting each session and at two follow-up sessions, 1 and 4 months after finishing the treatment.

  Baseline (day 1), Session2 (day 4), Session 3 (day 8), Session 4 (day 11), Session 5 (day 15), Session 6 (day 18), Session 7 (day 22), Session 8 (day 25), Session 9 (day 29), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up(day 150)

Secondary Outcomes (5)

• Description of Pain: Mc Gill Pain Questionnaire validated to Spanish

  Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)

• General Health Short Form with the 36 Health Survery validated to Spanish

  Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)

• Oral patient's quality of life with the Oral Health Impact Profile 14 validated to Spanish

  Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)

• Epworth sleepiness scale validated to Spanish

  Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)

• Psychometris test Symptom Check List 90 validated to Spanish

  Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)

Study Arms (2)

Test group

EXPERIMENTAL

Low-Level Laser Therapy was applied in the test group with a Diode Laser Fox (A.R.C. Laser, Italy) using these parameters: a wavelength of 810 nm, a power of 0.6 W, a power density of 1.2 W/cm2, a beam area of 0.08 cm2 and an energy of 6 J with an application time per point of 10 seconds in 56 points (3 in the vestibular mucosa of the 4 quadrants, 6 in each of the two buccal mucosa, 6 in the hard palate, 4 in each lateral of the tongue, 6 in the dorsum of the tongue and 4 sublingual points) with a distance between points of 2mm. It was applied, therefore, a dose of 12 J/cm2 in a continuous mode in a total of 10 sessions, 2 sessions per week for 5 weeks.

Radiation: Photobiomodulation

Placebo group

PLACEBO COMPARATOR

Low-Level Laser Therapy was applied in the placebo group with a Diode Laser Fox (A.R.C. Laser, Italy) turned off with an application time per point of 10 seconds in 56 points (3 in the vestibular mucosa of the 4 quadrants, 6 in each of the two buccal mucosa, 6 in the hard palate, 4 in each lateral of the tongue, 6 in the dorsum of the tongue and 4 sublingual points) with a distance between points of 2mm. It was applied, therefore, a dose of 12 J/cm2 in a continuous mode in a total of 10 sessions, 2 sessions per week for 5 weeks.

Radiation: Placebo

Interventions

Photobiomodulation RADIATION

Photobiomodulation whit Low-Level Laser Therapy

Test group

Placebo RADIATION

Device turned off

Placebo group

Eligibility Criteria

• Age: 31 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients not interested in participate in the study, unable to understand or answer the questionnaires and follow the appointments, patients suffering hiposialia or Sjögren's syndrome, patients who had received head and neck radiotherapy, pregnant women, patients with uncontrolled systemic diseases (diabetes, thyroid diseases, fibromyalgia or anemia) and patients suffering burning mouth symptoms secondary to local factors

Sponsors & Collaborators

• Rosa María López-Pintor Muñoz: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28005, Spain

Location

Related Publications (2)

• Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

  PMID: 29368949 BACKGROUND

• Montero-Martin J, Bravo-Perez M, Albaladejo-Martinez A, Hernandez-Martin LA, Rosel-Gallardo EM. Validation the Oral Health Impact Profile (OHIP-14sp) for adults in Spain. Med Oral Patol Oral Cir Bucal. 2009 Jan 1;14(1):E44-50.

  PMID: 19114956 BACKGROUND

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Rosa María López-Pintor, PhD

  Universidad Complutense Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All patients were masked during all the trial. They wore protective glasses and were also advised to close their eyes during treatment. In addition, the laser was programmed not to emit any type of sound alarm. One clinician collected the Visual Analogue Scale and the questionnaires fulfilled by the patients and another clinician applied the laser treatment. All patients were warned of not speaking with the laser clinician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor; Co-director Speciality in Oral Medicine

Model Details: Randomized single blind placebo controlled study

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 26, 2019
• Study Start: April 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

ES (1)