Floral Remedies for Sleep-bruxism Patients

NCT03112954 | Completed

• 1 other identifier: temporal cephalic pain
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• temporal cephalic pain evaluation

  Pain Pain was evaluated twice, in the beginning and after 21 days of the treatment. Pain was scored using the visual analogue scale (VAS) described by Huskisson6 (1974) and modified by Finkel12. All results were recorded in each patient's folder, under restricted access. Patients, holding the VAS, were asked to point to the face/score number that indicated the level of his or her pain. Pain level was measured as follows: No pain or the absence of any discomfort, scored as 0 (zero); mild pain, scored from 1 to 3; moderate pain, scored as 4, 5, 6 or 7; and severe pain, scored as 8, 9 or 10.

  21 days

Secondary Outcomes (1)

• Sleep-quality assessment

  21 days

Study Arms (2)

Buccal-relaxant formula

EXPERIMENTAL

The buccal-relaxant formula used in this study contained 8 floral essences from native and non-native plants commonly grown in Brazil, developed at the Mater Gaia Institute. 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.

Drug: Buccal-relaxant formula

Placebo

EXPERIMENTAL

Each patient received a small amber glass bottle containing the placebo, and was instructed to use four drops sublingually 4 times a day for 22 days.

Drug: Placebo

Interventions

Buccal-relaxant formula DRUG

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.

Buccal-relaxant formula

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Shear noise and/or tooth-grinding, confirmed by a room companion or family member.
• Observation of wear facets on the tooth surfaces, incompatible with age and function.
• Presence of two or more symptoms, such as headache in the temporal region, rigid jaw muscles or fatigue at night or upon awakening, locking or difficulty in opening the mouth in the morning, dental hypersensitivity, hypertrophy of the masseter muscles.

You may not qualify if:

• Currently in treatment for bruxism, through the use of an interocclusal stabilization splint.
• Patients with alcoholism. Patients who make use of medications that affect episodes of bruxism, such as analgesics, anti-inflammatories, muscle relaxants, amphetamines, and inhibitors of serotonin reuptake.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Fluminese Federal University

Niterói, Rio de Janeiro, 24241, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: blind treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: cohort study.

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 13, 2017
• Study Start: May 29, 2014
• Primary Completion: June 11, 2014
• Study Completion: June 20, 2014
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)