Root Canal TherapyNCT05249686
Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention
A study testing Manual Therapy + Dry Needling and Manual Therapy in people with Root Canal Therapy and Endodontically Treated Teeth, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Root Canal Therapy, Endodontically Treated Teeth
- What is being tested?
- Manual Therapy + Dry Needling and Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 7 Mar 2022to 7 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years old and requiring an endodontic intervention.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Prácticas Odontológicas del Grado en Odontología de la Universidad de Zaragoza
Huesca, Aragon, 22006
About this study
Official title: 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.
- Conditions
- Root Canal Therapy, Endodontically Treated Teeth
- Being tested
- Manual Therapy + Dry Needling, Manual Therapy
- Keywords
- Dry Needling, Manual Therapy, Temporomandibular Joint, Cervical spine, Root Canal Therapy
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy + Dry NeedlingOther
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 TherapyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy + Dry Needling | Experimental | Not described Receives: Other: Manual Therapy + Dry Needling |
| Manual Therapy | Active comparator | Not described Receives: Other: Manual Therapy |
| Control | No intervention | The control group received only the dentist´s usual advice after endodontic surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 week
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start7 Mar 2022
- Primary completion7 May 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized controlled trial with 3 different groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Albarova-Corral, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249686
- Sponsor's protocol ID
- PI18/370
- Status last verified
- Nov 2022
- First submitted
- 8 Feb 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Physical Therapy Protocols After an Endodontic Intervention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05249686
- Acronym / sponsor ID
- PI18/370
- Conditions
- Root Canal Therapy, Endodontically Treated Teeth
- Keywords
- Dry Needling, Manual Therapy, Temporomandibular Joint, Cervical spine, Root Canal Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 May 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This will be a randomized controlled trial with 3 different groups
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy + Dry Needling | Experimental | Other: Manual Therapy + Dry Needling |
| Manual Therapy | Active comparator | Other: Manual Therapy |
| Control | No intervention | –The control group received only the dentist´s usual advice after endodontic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being over 18 years old and requiring an endodontic intervention.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy + Dry NeedlingDry 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). | Other | Manual Therapy + Dry Needling |
| Manual TherapyManual 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). | Other | Manual Therapy |
Primary outcome
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.
9 secondary outcomes
Mean change from baseline in Pain intensity at 1 week
Time frame: Baseline and 1 week
Mean change from baseline in Pressure Pain Threshold (PPT) at 1 week
Time frame: Baseline and 1 week
Mean change from baseline in Myofascial Trigger Points (MTrPs) at 1 week
Time frame: Baseline and 1 week
Mean change from baseline in Cervical Spine Range of Movement (ROM) at 1 week
Time frame: Baseline and 1 week
Mean change from baseline in TMD-Pain Screener (TMJ Function) at 1 week
Time frame: Baseline and 1 week
Mean change from baseline in Helkimo Index (TMJ Function) at 1 week
Time frame: Baseline and 1 week
Mean change from baseline in Jaw Functional Limitation Scale (JFLS-20) (TMJ Function)
Time frame: Baseline and 1 week
Mean change from baseline in Neck Disability Index (NDI) (Neck Function) at 1 week
Time frame: Baseline and 1 week
Mean change from baseline in Headache Impact Test (HIT-6) (Headache Disfunction) at 1 week
Time frame: Baseline and 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy + Dry Needling and Manual Therapy in people with Root Canal Therapy and Endodontically Treated Teeth, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in Maximum Active Mouth Opening at 1 week (time frame: Baseline and 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.