Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Endodontically Treated Teeth; Root Canal Therapy
• Intervention / Treatment: Other: Manual Therapy + Dry Needling; Other: Manual Therapy

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Aragon
    • Huesca, Aragon, Spain, 22006
      • Servicio de Prácticas Odontológicas del Grado en Odontología de la Universidad de Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Therapy + Dry Needling	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).
Active Comparator: Manual Therapy	Other: 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).
No Intervention: Control; The control group received only the dentist´s usual advice after endodontic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): May 7, 2022
• Study Completion (Actual): June 7, 2022

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Dry Needling; Manual Therapy; Cervical spine; Temporomandibular Joint; Root Canal Therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: PI18/370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No