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Completed

NCT Number: NCT05249686

Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention

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.

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Key information

Conditions

Root Canal Therapy Dental Pulp Diseases Endodontically Treated Teeth Stomatognathic Diseases Tooth Diseases Tooth, Nonvital

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Prácticas Odontológicas del Grado en Odontología de la Universidad de Zaragoza

Huesca, Aragon, 22006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Manual Therapy + Dry Needling

Other

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

Other

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 outcomes

  1. Mean change from baseline in Maximum Active Mouth Opening at 1 week

    Time frame: 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 outcomes

  1. Mean change from baseline in Pain intensity at 1 week

    Time frame: 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).

  2. Mean change from baseline in Pressure Pain Threshold (PPT) at 1 week

    Time frame: 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.

  3. Mean change from baseline in Myofascial Trigger Points (MTrPs) at 1 week

    Time frame: 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.

  4. Mean change from baseline in Cervical Spine Range of Movement (ROM) at 1 week

    Time frame: 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.

  5. Mean change from baseline in TMD-Pain Screener (TMJ Function) at 1 week

    Time frame: Baseline and 1 week

    The examiners assess temporomandibular disorders (TMDs) using this screening instrument f

  6. Mean change from baseline in Helkimo Index (TMJ Function) at 1 week

    Time frame: Baseline and 1 week

    The examiners assess the severity and pain of TMDs patients using the Helkimo Index.

  7. Mean change from baseline in Jaw Functional Limitation Scale (JFLS-20) (TMJ Function)

    Time frame: 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.

  8. Mean change from baseline in Neck Disability Index (NDI) (Neck Function) at 1 week

    Time frame: Baseline and 1 week

    The examiners assess the self-perceived disability from neck pain using the NDI.

  9. Mean change from baseline in Headache Impact Test (HIT-6) (Headache Disfunction) at 1 week

    Time frame: Baseline and 1 week

    The examiners assess the impact of headache on patients' lives using the HIT-6.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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