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Completed

NCT Number: NCT04475614

Therapeutic Options for Treatment of Burning Mouth Syndrome

Burning mouth syndrome is a painful condition of unknown etiology that impairs the quality of life and does not have an adequate therapeutic option. The purpose of this study is to determine the most effective treatment option for burning mouth syndrome, among oral probiotics, low-level laser, B-vitamin injections and informative treatment only.

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Key information

Conditions

Burning Mouth Syndrome Mouth Diseases Stomatognathic Diseases

Age range

39 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed with burning mouth syndrome and excluded local and systemic causes

Exclusion criteria

  • patients who have received treatment for burning mouth earlier
  • patients with local or systemic causes of burning mouth

Treatment and study plan

BioGaia Prodentis lozenges

Dietary Supplement

oral probiotics

low level laser treatment with Ga-Al-As laser

Procedure

low level laser treatment

B vitamin injections (Neurobion, Merck, Darmstadt, Germany)

Dietary Supplement

intra muscular vitamin injections

Primary outcomes

  1. Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14)

    Time frame: up to two months (follow up was one month after the end of treatment, in each patient)

    change in the patient's quality of life determined by self-perceived quality of life questionnaire (Oral Health Impact Profile; OHIP-14)

Secondary outcomes

  1. Change in subjective burning symptoms

    Time frame: up to two months (follow up was one month after the end of treatment, in each patient)

    change of patient's subjective burning symptoms measured on visual analogue scale (VAS) grading from 0 to 10 (0- without burning, 10- the worst possible burning)

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Official study title

Different Therapeutic Options for Burning Mouth Syndrome

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2020
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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