NCT07868341

Brief Summary

This study will compare the effect of three different physical therapy techniques on stress level on patients with bruxism by assessment of morning salivary biomarkers.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Sep 2026Oct 2026

Study Start

First participant enrolled

September 21, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2026

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

1 month

First QC Date

September 25, 2026

Last Update Submit

October 8, 2026

Conditions

Keywords

BruxismElectromyographyBiofeedbackSalivary cortisol levelprogressive muscle relaxation

Outcome Measures

Primary Outcomes (1)

  • Morning salivary cortisol level

    morning salivary cortisol reflect the stress level before and after the intervention on the 3 groups

    1 month

Study Arms (3)

group A

EXPERIMENTAL

15 Patients

Other: The Rocabado Program

B

EXPERIMENTAL

15 Patients

Other: Jacobson Progressive Muscle Relaxation Technique

C

EXPERIMENTAL

15 patients

Other: Surface electromyography biofeedback

Interventions

The Rocabado program include learning a new postural position, restoring original muscle length and stiffness, normal joint mobility, and body balance.

group A

Jacobson developed the method of progressive muscle relaxation progressive muscle relaxation method as a supportive therapy for the treatment of neurological disorders.

B

A non invasive process by surface electrodes that using visual and auditory cues via electronic monitoring of a normally masticatory function to train bruxers to acquire voluntary control of the hyperactivity

C

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mild to moderate bruxism according to BRUX Scale.
  • At least one of the following conditions: a history of tooth clenching or grinding sounds during the last 6 months, pain around the temporomandibular joint causing discomfort in the morning, tenderness of masticatory muscles on palpation, masticatory muscle hypertrophy, tooth indication on the cheek mucosa and or tongue.
  • Moderate stress level ranged from 14-26 according to the perceived stress scale.

You may not qualify if:

  • Received any Botox, PRP (Plasma rich platelets) injection treatment for this condition for the last six months.
  • Sever cases
  • Any advanced periodontal disease as malocclusion
  • Any intra oral fixed splints
  • Pregnancy
  • Hypertension
  • Under psychiatric care
  • Parkinson's and any other neurological disease affecting the orofacial function or lead to masticatory muscles hyperactivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr university for Science and Technology

Giza, 3237101, Egypt

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Central Study Contacts

Myassar Ayman Amine, Master's degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Forty five male and female patients with mild and moderate bruxism participated in this study; they were divided into three equal groups the mean values ± SD of patients age of groups A, B and C were 25.6 ± 3.33, 25.67 ± 3.89 and 24.93 ± 3.22 years respectively, There was no statistical significant difference between the three groups in the mean values of age (p=0.818)., group A received 12 sessions of Rocabado program, group B received 12 sessions of Jacobson progressive muscle relaxation and group C received 12 sessions of electromyography biofeedback. Data obtained from three groups pre and post treatment regarding the morning cortisol level to measure the level of the stress.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer , Department of Neurological rehabilitation , College of physical Therapy

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 9, 2026

Study Start

September 21, 2026

Primary Completion (Estimated)

October 21, 2026

Study Completion (Estimated)

October 21, 2026

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share

Morning salivary cortisol levels before and after

Shared Documents
STUDY PROTOCOL
Time Frame
1 May 2027 up to 1 October 2027
Access Criteria
Data reported in this study will be available to qualified researchers upon reasonable request. Supporting documents, including the study protocol and statistical analysis plan, will be provided. Requests should be submitted to the principal investigator via E-mail address and will be reviewed ethical and institutional requirements. Access will be granted after approval and execution of a data-sharing agreement.

Locations