NCT02908568

Brief Summary

Study over muscular stretching to reduce pain the oral cavity.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

September 7, 2016

Last Update Submit

September 21, 2016

Conditions

Temporomandibular Joint Disorders

Keywords

mandibular stretching, trigeminocardiac reflex

Outcome Measures

Primary Outcomes (1)

  • Mandibular stretching influences the temporomandibular disorders

    It is a current opinion that muscular stretching is able to reduce pain and to allow increase of the opening excursion at the joints. To investigate this possibility in the face, the investigators developed a method of stretching associated with large dynamic jaws during chewing using a special device (Spring Device ®) for ten minutes, allowing the muscles of the oral cavity to relax.

    up to 24 weeks

Secondary Outcomes (1)

  • mandibular stretching induces a reduction of facial contraction and decrease of heart rate

    up to 24 weeks

Study Arms (2)

Spring device

EXPERIMENTAL

Brisk dilatation of fhe mouth.

Device: Spring device

Mandible stimulator

SHAM COMPARATOR

Stimulation of fhe mouth.

Device: Mandible stimulator

Interventions

Spring deviceDEVICE

Brisk dilatation of fhe mouth.

Spring device
Mandible stimulatorDEVICE

Stimulation of fhe mouth.

Mandible stimulator

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All the subjets up to seventy years

You may not qualify if:

  • Subjects under eight years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tonlorenzi D, Brunelli M, Conti M, Covani U, Traina G. An observational study of the effects of using an high oral splint on pain control. Arch Ital Biol. 2019 Sep 30;157(2-3):66-75. doi: 10.12871/00039829201923.

    PMID: 31821530DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Azienda USL 12 Versilia

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 21, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 22, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share