Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention
Primary Purpose
Root Canal Therapy, Endodontically Treated Teeth
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy + Dry Needling
Manual Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Root Canal Therapy focused on measuring Dry Needling, Manual Therapy, Temporomandibular Joint, Cervical spine, Root Canal Therapy
Eligibility Criteria
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).
Sites / Locations
- Servicio de Prácticas Odontológicas del Grado en Odontología de la Universidad de Zaragoza
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Manual Therapy + Dry Needling
Manual Therapy
Control
Arm Description
The control group received only the dentist´s usual advice after endodontic surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
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.
Mean change from baseline in TMD-Pain Screener (TMJ Function) at 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
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)
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
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
The examiners assess the impact of headache on patients' lives using the HIT-6.
Full Information
NCT ID
NCT05249686
First Posted
February 8, 2022
Last Updated
November 7, 2022
Sponsor
Universidad de Zaragoza
1. Study Identification
Unique Protocol Identification Number
NCT05249686
Brief Title
Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention
Official Title
Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
May 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Therapy, Endodontically Treated Teeth
Keywords
Dry Needling, Manual Therapy, Temporomandibular Joint, Cervical spine, Root Canal Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized controlled trial with 3 different groups
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Therapy + Dry Needling
Arm Type
Experimental
Arm Title
Manual Therapy
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group received only the dentist´s usual advice after endodontic surgery.
Intervention Type
Other
Intervention Name(s)
Manual Therapy + Dry Needling
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Mean change from baseline in Maximum Active Mouth Opening at 1 week
Description
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.
Time Frame
Baseline and 1 week
Secondary Outcome Measure Information:
Title
Mean change from baseline in Pain intensity at 1 week
Description
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).
Time Frame
Baseline and 1 week
Title
Mean change from baseline in Pressure Pain Threshold (PPT) at 1 week
Description
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.
Time Frame
Baseline and 1 week
Title
Mean change from baseline in Myofascial Trigger Points (MTrPs) at 1 week
Description
The following muscles of the temporomandibular and cervical regions will be examined: masseter, temporalis, sternocleidomastoid, upper trapezius, splenius capitis and suboccipital muscles.
Time Frame
Baseline and 1 week
Title
Mean change from baseline in Cervical Spine Range of Movement (ROM) at 1 week
Description
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.
Time Frame
Baseline and 1 week
Title
Mean change from baseline in TMD-Pain Screener (TMJ Function) at 1 week
Description
The examiners assess temporomandibular disorders (TMDs) using this screening instrument f
Time Frame
Baseline and 1 week
Title
Mean change from baseline in Helkimo Index (TMJ Function) at 1 week
Description
The examiners assess the severity and pain of TMDs patients using the Helkimo Index.
Time Frame
Baseline and 1 week
Title
Mean change from baseline in Jaw Functional Limitation Scale (JFLS-20) (TMJ Function)
Description
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.
Time Frame
Baseline and 1 week
Title
Mean change from baseline in Neck Disability Index (NDI) (Neck Function) at 1 week
Description
The examiners assess the self-perceived disability from neck pain using the NDI.
Time Frame
Baseline and 1 week
Title
Mean change from baseline in Headache Impact Test (HIT-6) (Headache Disfunction) at 1 week
Description
The examiners assess the impact of headache on patients' lives using the HIT-6.
Time Frame
Baseline and 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Servicio de Prácticas Odontológicas del Grado en Odontología de la Universidad de Zaragoza
City
Huesca
State/Province
Aragon
ZIP/Postal Code
22006
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention
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