Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention

Sponsor

Universidad de Zaragoza (Other)

Overall Status

Recruiting

CT.gov ID

NCT05249686

Collaborator

(none)

Enrollment

Location

Arms

2.8

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Root Canal Therapy Endodontically Treated Teeth	Other: Manual Therapy + Dry Needling Other: Manual Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This will be a randomized controlled trial with 3 different groupsThis will be a randomized controlled trial with 3 different groups

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 7, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).