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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05249686
Enrollment
29
Registered
2022-02-22
Start date
2022-03-07
Completion date
2022-06-07
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endodontically Treated Teeth, Root Canal Therapy

Keywords

Dry Needling, Manual Therapy, Temporomandibular Joint, Cervical spine, Root Canal Therapy

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.

Interventions

OTHERManual 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).

OTHERManual 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).

Sponsors

Universidad de Zaragoza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

This will be a randomized controlled trial with 3 different groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Mean change from baseline in Maximum Active Mouth Opening at 1 weekBaseline and 1 weekAn 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

MeasureTime frameDescription
Mean change from baseline in Pressure Pain Threshold (PPT) at 1 weekBaseline and 1 weekThe 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 weekBaseline and 1 weekThe 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 weekBaseline and 1 weekThe 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 weekBaseline and 1 weekThe examiners assess temporomandibular disorders (TMDs) using this screening instrument f
Mean change from baseline in Pain intensity at 1 weekBaseline and 1 weekPain 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 Jaw Functional Limitation Scale (JFLS-20) (TMJ Function)Baseline and 1 weekThe 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 weekBaseline and 1 weekThe 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 weekBaseline and 1 weekThe examiners assess the impact of headache on patients' lives using the HIT-6.
Mean change from baseline in Helkimo Index (TMJ Function) at 1 weekBaseline and 1 weekThe examiners assess the severity and pain of TMDs patients using the Helkimo Index.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026