Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention

Endodontically Treated Teeth Clinical Trial

Official title:

Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249686
• Other study ID #: PI18/370
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: June 7, 2022

Study information

• Verified date: November 2022
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 7, 2022
• Est. primary completion date: May 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Root Canal Therapy
• Tooth, Nonvital

Intervention

Other:
• Manual Therapy + Dry Needling
Dry Needling: This is a minimally invasive procedure where a fine needle or acupuncture needle is inserted into the skin and muscle in order to stimulate myofascial trigger points (MTrP) provoking one to six local twitch responses (LTR). Manual Therapy Protocol: Intraoral manual techniques were applied to the musculature of both sides, both masseter and medial pterygoid, consisting of both massage and stretching. Furthermore, a grade I-II in the slack-zone traction was applied in the temporomandibular joint (TMJ).
• Manual Therapy
Manual Therapy Protocol: Intraoral manual techniques were applied to the musculature of both sides, both masseter and medial pterygoid, consisting of both massage and stretching. Furthermore, a grade I-II in the slack-zone traction was applied in the temporomandibular joint (TMJ).

Locations

Country	Name	City	State
Spain	Servicio de Prácticas Odontológicas del Grado en Odontología de la Universidad de Zaragoza	Huesca	Aragon

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in Maximum Active Mouth Opening at 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.	Baseline and 1 week
Secondary	Mean change from baseline in Pain intensity at 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).	Baseline and 1 week
Secondary	Mean change from baseline in Pressure Pain Threshold (PPT) at 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.	Baseline and 1 week
Secondary	Mean change from baseline in Myofascial Trigger Points (MTrPs) at 1 week	The following muscles of the temporomandibular and cervical regions will be examined: masseter, temporalis, sternocleidomastoid, upper trapezius, splenius capitis and suboccipital muscles.	Baseline and 1 week
Secondary	Mean change from baseline in Cervical Spine Range of Movement (ROM) at 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.	Baseline and 1 week
Secondary	Mean change from baseline in TMD-Pain Screener (TMJ Function) at 1 week	The examiners assess temporomandibular disorders (TMDs) using this screening instrument f	Baseline and 1 week
Secondary	Mean change from baseline in Helkimo Index (TMJ Function) at 1 week	The examiners assess the severity and pain of TMDs patients using the Helkimo Index.	Baseline and 1 week
Secondary	Mean change from baseline in Jaw Functional Limitation Scale (JFLS-20) (TMJ Function)	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.	Baseline and 1 week
Secondary	Mean change from baseline in Neck Disability Index (NDI) (Neck Function) at 1 week	The examiners assess the self-perceived disability from neck pain using the NDI.	Baseline and 1 week
Secondary	Mean change from baseline in Headache Impact Test (HIT-6) (Headache Disfunction) at 1 week	The examiners assess the impact of headache on patients' lives using the HIT-6.	Baseline and 1 week