Therapeutic Options for Treatment of Burning Mouth Syndrome

NCT04475614 | Completed

• 1 other identifier: 01072018
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burning Mouth Syndrome

Keywords

burning mouth syndrome; treatment

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (1)

• Change in subjective burning symptoms

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

Study Arms (4)

informative

NO INTERVENTION

The patients in this group received only verbal and written information about their condition.

oral probiotics

EXPERIMENTAL

The patients in this group, beside verbal and written information about their condition, received also oral probiotics. They were instructed to melt one lozenge in the mouth in the evening, after tooth brushing and flossing, for one month.

Dietary Supplement: BioGaia Prodentis lozenges

low level laser treatment

EXPERIMENTAL

The patients in this group, beside verbal and written information about their condition, received a total of ten low level laser treatments, for ten days consecutively excluding weekends.

Procedure: low level laser treatment with Ga-Al-As laser

B-vitamin injections

EXPERIMENTAL

The patients in this group, beside verbal and written information about their condition, received a total of nine B vitamin injections, every other day, intra muscular.

Dietary Supplement: B vitamin injections (Neurobion, Merck, Darmstadt, Germany)

Interventions

BioGaia Prodentis lozenges DIETARY_SUPPLEMENT

oral probiotics

oral probiotics

low level laser treatment with Ga-Al-As laser PROCEDURE

low level laser treatment

low level laser treatment

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

intra muscular vitamin injections

B-vitamin injections

Eligibility Criteria

• Age: 39 Years - 83 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Vitamin B Complex

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 17, 2020
• Study Start: September 15, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)