NCT05249686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

February 8, 2022

Last Update Submit

November 7, 2022

Conditions

Root Canal TherapyEndodontically Treated Teeth

Keywords

Dry NeedlingManual TherapyTemporomandibular JointCervical spineRoot Canal Therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 1 week

Secondary Outcomes (9)

  • Mean change from baseline in Pain intensity at 1 week

    Baseline and 1 week

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

    Baseline and 1 week

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

    Baseline and 1 week

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

    Baseline and 1 week

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

    Baseline and 1 week

  • +4 more secondary outcomes

Study Arms (3)

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.

Interventions

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 Therapy + Dry Needling
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).

Manual Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old and requiring an endodontic intervention.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Huesca, Aragon, 22006, Spain

Location

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Musculoskeletal ManipulationsDry Needling

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This will be a randomized controlled trial with 3 different groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Lecturer in Physiotherapy

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 22, 2022

Study Start

March 7, 2022

Primary Completion

May 7, 2022

Study Completion

June 7, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)