Floral Remedies for Sleep-bruxism Patients

Summary

Introduction: Bruxism is a parafunctional habit that affects the stomatognathic system and its support structures. Usually associated with stress and mostly occurring at night, bruxism leads to sleep disorders and daily tension headaches. Aiming to rebalance the emotional and physical state of patients, floral-essence therapy lacks side effects or drug interactions, and has been recognized by the World Health Organization. Aim and Methods: The investigators created a buccal-relaxant formula, combining 8 floral essences and testing it in a double-blind clinical assay conducted in bruxism patients. Results: An alcohol solution of the buccal relaxant containing Daughter of Gaia floral essences of Taraxacum officinale, Antirrhinum majus, Fuchsia × hybrida, Bidens bipinnata, Campanula carpatica, Achyrocline, Nymphaea caerulea, and Tetraoensis riparia significantly attenuated temporal headaches in the bruxism patients compared to the placebo group (69.46%±1.79 versus 3.55%±1.37, P=0.0001). Moreover, patients after 21 days using the buccal relaxant increased their quality of sleep and experienced attenuated jaw-muscle rigidity or morning mouth-opening difficulties. Less masseter hypertrophy and reduced sensitivity due to abfraction of enamel facets were noted as well. Conclusions: The buccal-relaxant formula may have sedative properties, preventing daily temporal headaches in sleep-bruxism patients, suggesting a muscle-relaxation effect. Although the results are promising, long-term studies are needed to clarify the pharmacological mechanism of each floral essence in the buccal-relaxant formula and their tolerance effects.

Conditions

• Temporal Cephalic Pain

Interventions

DRUG

Buccal-relaxant formula

Following physical examinations, 60 patients were randomly allocated to 2 groups of 30 patients each, who had been diagnosed with sleep bruxism. Each patient received a small amber glass bottle containing the floral remedy and was instructed to use four drops sublingually 4 times a day for 22 days. All examiners were different professionals, with no contact among each other, as follows: an examiner who conducted the physical examination, an examiner who randomly divided the patients, and an examiner who prepared the floral and placebo remedies. At the end of the study, each group of 30 patients was re-named: Group F, the group of patients who received the floral remedy.

DRUG

Placebo

30 patients diagnosed with sleep bruxism received a small amber glass bottle containing the saline solution and was instructed to use four drops sublingually 4 times a day for 22 days. All examiners were different professionals, with no contact among each other, as follows: an examiner who conducted the physical examination, an examiner who randomly divided the patients, and an examiner who prepared the floral and placebo remedies. At the end of the study, each group of 30 patients was re-named: Group P, the group of patients who received the placebo.

Sponsors & Collaborators

• Universidade Federal Fluminense

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-05-29

Primary Completion

2014-06-11

Completion

2014-06-20

Countries

• Brazil

Study Locations