Temporomandibular Disorders (TMD)NCT06853028
The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance
An observational study of Temporomandibular Disorders (TMD) and Acute Apical Periodontitis of Pulpal Origin, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The study hypothesizes that masticatory laterality caused by acute apical periodontitis pain result in muscle asymmetry. Furthermore, it posits that successful root canal treatment, by restoring normal bilateral chewing function, will reduce this asymmetry, as evidenced by ultrasonographic measurements of the masseter… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorders (TMD), Acute Apical Periodontitis of Pulpal Origin
- What is being tested?
- ultrasound measurement
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Aug 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: •. 20 systemically healthy patients (11 female, 9 male) aged 18-60 years * Patients with masticatory laterality due to tooth pain for at least 30 days * First and second maxillary or mandibular molars with acute apical periodontitis due to deep caries * Teeth with moderate or severe pain according to the VAS (no pain (0 mm), mild pain (1-3 mm), moderate pain (4-6 mm), and severe pain (7-10 mm)) * Teeth that responded positively to percussion test * Teeth without periapical pathosis
Who may be able to join
- Patients with masticatory laterality due to tooth pain for at least 30 days
- First and second maxillary or mandibular molars with acute apical periodontitis due to deep caries
- Teeth with moderate or severe pain according to the VAS (no pain (0 mm), mild pain (1-3 mm), moderate pain (4-6 mm), and severe pain (7-10 mm))
- Teeth that responded positively to percussion test
- Teeth without periapical pathosis were included in the study. Exclusion Criteria
- Systemic conditions affecting muscle structure or function, such as neuromuscular or endocrine disorders.
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- Non-endodontic odontogenic pain.
- Prior endodontic treatment of the relevant tooth within the last 30 days.
- History of trauma or surgery to the head, face, or teeth within the last six months.
- Severe communication disorders or psychological issues.
- Inability to complete treatment in a single visit due to exudation or bleeding
- Patients with masticatory laterality due to missing tooth on any side of the dental arch
- Patients who have painful teeth in opposite sides of the dental arch
- TMD patients were excluded from the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye
Adana, 01250
About this study
Official title: The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance: a Prospective Cohort Study
The study hypothesizes that masticatory laterality caused by acute apical periodontitis pain result in muscle asymmetry. Furthermore, it posits that successful root canal treatment, by restoring normal bilateral chewing function, will reduce this asymmetry, as evidenced by ultrasonographic measurements of the masseter and anterior temporal muscles.The main question it aims to answer is:
Can bilateral chewing function be restored after root canal treatment procedures in patients with masticatory laterality due to painful teeth due to acute apical periodontitis?
- Being tested
- ultrasound measurement
- Keywords
- root canal treatment, ultrasonography, endodontic pain, acute apical periodontitis, masticatory laterality
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound measurementOther
Muscle thickness measurements were performed with the ultrasound device immediately before root canal treatment, 1 week after, and 3 months after the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a masticatory laterality due to acute apical periodontitis | Not described Receives: Other: ultrasound measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography
Ultrasound (also called sonography or ultrasonography) is a noninvasive imaging test. An ultrasound picture is called a sonogram. Ultrasound uses high-frequency sound waves to create real-time pictures or video of internal organs or other soft tissues, such as blood vessels. The masseter and anterior temporal muscle thicknesses of the patients were measured bilaterally using a high-frequency linear scanning probe (7 MHz) in B-mode of the Clarius Mobile Health ultrasound device (Vancouver, Canada). As no established formula exists to calculate muscle thickness asymmetry, the asymmetry index was based on another study in the literature.
Asymmetry Index = [(Control Side - Painful Side) / (Control Side + Painful Side)] × 100
Measured: immediately before root canal treatment, 1 week after and 3 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Gürler, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853028
- Sponsor's protocol ID
- 10.05.2024/144
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elbarbary M, Sgro A, Khazaei S, Goldberg M, Tenenbaum HC, Azarpazhooh A. The applications of ultrasound, and ultrasonography in dentistry: a scoping review of the literature. Clin Oral Investig. 2022 Mar;26(3):2299-2316. doi: 10.1007/s00784-021-04340-6. Epub 2022 Jan 14.
PubMed 35028733Jeon HM, Ahn YW, Jeong SH, Ok SM, Choi J, Lee JY, Joo JY, Kwon EY. Pattern analysis of patients with temporomandibular disorders resulting from unilateral mastication due to chronic periodontitis. J Periodontal Implant Sci. 2017 Aug;47(4):211-218. doi: 10.5051/jpis.2017.47.4.211. Epub 2017 Aug 21.
PubMed 28861285Daline IH, Slade GD, Fouad AF, Nixdorf DR, Tchivileva IE. Prevalence of painful temporomandibular disorders in endodontic patients with tooth pain. J Oral Rehabil. 2023 Jul;50(7):537-547. doi: 10.1111/joor.13457. Epub 2023 Apr 14.
PubMed 37021602Gurler K, Guner Akgul I, Duyan Yuksel H, Sisli SN. The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance: A Self-Controlled Prospective Observational Study. Aust Endod J. 2025 Dec;51(3):650-659. doi: 10.1111/aej.12979. Epub 2025 Jul 29.
PubMed 40726276
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06853028
- Acronym / sponsor ID
- 10.05.2024/144
- Keywords
- root canal treatment, ultrasonography, endodontic pain, acute apical periodontitis, masticatory laterality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 28 Feb 2025 (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 study hypothesizes that masticatory laterality caused by acute apical periodontitis pain result in muscle asymmetry. Furthermore, it posits that successful root canal treatment, by restoring normal bilateral chewing function, will reduce this asymmetry, as evidenced by ultrasonographic measurements of the masseter and anterior temporal muscles.The main question it aims to answer is:
Can bilateral chewing function be restored after root canal treatment procedures in patients with masticatory laterality due to painful teeth due to acute apical periodontitis?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a masticatory laterality due to acute apical periodontitis | – | Other: ultrasound measurement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- •. 20 systemically healthy patients (11 female, 9 male) aged 18-60 years * Patients with masticatory laterality due to tooth pain for at least 30 days * First and second maxillary or mandibular molars with acute apical periodontitis due to deep caries * Teeth with moderate or severe pain according to the VAS (no pain (0 mm), mild pain (1-3 mm), moderate pain (4-6 mm), and severe pain (7-10 mm)) * Teeth that responded positively to percussion test * Teeth without periapical pathosis
Key inclusion criteria (14 listed)
- Patients with masticatory laterality due to tooth pain for at least 30 days
- First and second maxillary or mandibular molars with acute apical periodontitis due to deep caries
- Teeth with moderate or severe pain according to the VAS (no pain (0 mm), mild pain (1-3 mm), moderate pain (4-6 mm), and severe pain (7-10 mm))
- Teeth that responded positively to percussion test
- Teeth without periapical pathosis were included in the study. Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ultrasound measurementMuscle thickness measurements were performed with the ultrasound device immediately before root canal treatment, 1 week after, and 3 months after the treatment. | Other | Patients with a masticatory laterality due to acute apical periodontitis |
Primary outcome
Ultrasonography
Time frame: immediately before root canal treatment, 1 week after and 3 months after the treatment
Ultrasound (also called sonography or ultrasonography) is a noninvasive imaging test. An ultrasound picture is called a sonogram. Ultrasound uses high-frequency sound waves to create real-time pictures or video of internal organs or other soft tissues, such as blood vessels. The masseter and anterior temporal muscle thicknesses of the patients were measured bilaterally using a high-frequency linear scanning probe (7 MHz) in B-mode of the Clarius Mobile Health ultrasound device (Vancouver, Canada). As no established formula exists to calculate muscle thickness asymmetry, the asymmetry index was based on another study in the literature. Asymmetry Index = [(Control Side - Painful Side) / (Control Side + Painful Side)] × 100
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 4 Mar 2025.
- Background: PubMed 35028733Elbarbary M, Sgro A, Khazaei S, Goldberg M, Tenenbaum HC, Azarpazhooh A. The applications of ultrasound, and ultrasonography in dentistry: a scoping review of the literature. Clin Oral Investig. 2022 Mar;26(3):2299-2316. doi: 10.1007/s00784-021-04340-6. Epub 2022 Jan 14.
- Background: PubMed 28861285Jeon HM, Ahn YW, Jeong SH, Ok SM, Choi J, Lee JY, Joo JY, Kwon EY. Pattern analysis of patients with temporomandibular disorders resulting from unilateral mastication due to chronic periodontitis. J Periodontal Implant Sci. 2017 Aug;47(4):211-218. doi: 10.5051/jpis.2017.47.4.211. Epub 2017 Aug 21.
- Background: PubMed 37021602Daline IH, Slade GD, Fouad AF, Nixdorf DR, Tchivileva IE. Prevalence of painful temporomandibular disorders in endodontic patients with tooth pain. J Oral Rehabil. 2023 Jul;50(7):537-547. doi: 10.1111/joor.13457. Epub 2023 Apr 14.
- Derived from this study: PubMed 40726276Gurler K, Guner Akgul I, Duyan Yuksel H, Sisli SN. The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance: A Self-Controlled Prospective Observational Study. Aust Endod J. 2025 Dec;51(3):650-659. doi: 10.1111/aej.12979. Epub 2025 Jul 29.
- 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?
An observational study of Temporomandibular Disorders (TMD) and Acute Apical Periodontitis of Pulpal Origin, run by Cukurova University at 1 site in Turkey (Türkiye).
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 14 inclusion and 0 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 4 Mar 2025. 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 Turkey (Türkiye). 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?
Ultrasonography (time frame: immediately before root canal treatment, 1 week after and 3 months after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06853028, which also lists 4 linked publications.
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 4 Mar 2025.