Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention

Not Applicable

Completed

• Conditions: Root Canal Therapy; Endodontically Treated Teeth
• Interventions: Other: Manual Therapy + Dry Needling; Other: Manual Therapy

• Registration Number: NCT05249686
• Lead Sponsor: Universidad de Zaragoza

Brief Summary

The purpose of this study was to evaluate the clinical results produced by a manual therapy treatment combined with dry needling (MT+DN) and a manual therapy treatment (TM) versus a control (C), to normalize the altered cervico-mandibular variables after a session of root canal therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-20
• Study First Posted: 2022-02-22
• Study Start: 2022-03-07
• Primary Completion: 2022-05-07
• Study Completion: 2022-06-07
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Being over 18 years old and requiring an endodontic intervention.

Exclusion Criteria

• Have received TMJ or cervical treatment during the last month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Therapy + Dry Needling	Manual Therapy + Dry Needling	-
Manual Therapy	Manual Therapy	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in Maximum Active Mouth Opening at 1 week	Baseline and 1 week	An electronic caliper (HIBOK DC-516) will be used to measure maximum active mouth opening in supine position. Patients will be instructed to open the mouth as wide as possible without feeling any pain and the distance between upper-lower central incisors (intercisal distance) will be measured in mm.

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in Pain intensity at 1 week	Baseline and 1 week	Pain intensity will be measured using a visual analogue scale (VAS) from 0 to 10 (where 0 is no pain and 10 is the worst pain imaginable).
Mean change from baseline in Pressure Pain Threshold (PPT) at 1 week	Baseline and 1 week	The examiners assess the PPT using a handheld algometer (Wagner, Model FPK). The PPT will be measured bilaterally in the following points of the craniofacial and cervical region: masseter, temporalis, upper trapezius, splenius capitis and suboccipital muscles, and temporomandibular joint. The thenar eminence will be also measured in order to evaluate central sensitization (general pain hypersensitivity) within an intervention-free anatomical location.
Mean change from baseline in Myofascial Trigger Points (MTrPs) at 1 week	Baseline and 1 week	The following muscles of the temporomandibular and cervical regions will be examined: masseter, temporalis, sternocleidomastoid, upper trapezius, splenius capitis and suboccipital muscles.
Mean change from baseline in Headache Impact Test (HIT-6) (Headache Disfunction) at 1 week	Baseline and 1 week	The examiners assess the impact of headache on patients' lives using the HIT-6.
Mean change from baseline in Cervical Spine Range of Movement (ROM) at 1 week	Baseline and 1 week	The examiners assess the cervical ROM using the Clinometer App (version 2.4) for smartphone and a standard goniometer. Cervical flexion, extension, right/left sidebending, right/left rotation, as well as upper cervical spine flexion and extension will be evaluated.
Mean change from baseline in TMD-Pain Screener (TMJ Function) at 1 week	Baseline and 1 week	The examiners assess temporomandibular disorders (TMDs) using this screening instrument f
Mean change from baseline in Helkimo Index (TMJ Function) at 1 week	Baseline and 1 week	The examiners assess the severity and pain of TMDs patients using the Helkimo Index.
Mean change from baseline in Jaw Functional Limitation Scale (JFLS-20) (TMJ Function)	Baseline and 1 week	The examiners assess the functional limitation globally during the last month using the JFLS-20. Subjects must indicate the level of limitation during the last week in a range from 0 to 10.
Mean change from baseline in Neck Disability Index (NDI) (Neck Function) at 1 week	Baseline and 1 week	The examiners assess the self-perceived disability from neck pain using the NDI.

Trial Locations

Locations (1)

Servicio de Prácticas Odontológicas del Grado en Odontología de la Universidad de Zaragoza; 🇪🇸 Huesca, Aragon, Spain