Acute Apical Periodontitis of Pulpal OriginNCT06734559
Assessment of Masseter Muscle With Ultrasonography
A study testing Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours. and patients who have not acute apical periodontitis in people with Acute Apical Periodontitis of Pulpal Origin, run by Harran University at 2 sites in Turkey (Türkiye).
Trial summary
In teeth that remain decayed for a long time, the muscles in that area atrophy because the patient cannot use the decayed area much. As a result, muscle length and mass decrease. To compare the amount of this reduction before and after treatment with ultrasound and to treat accordingly Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Apical Periodontitis of Pulpal Origin
- What is being tested?
- Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours. and patients who have not acute apical periodontitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy adults aged 18-65 years (American Society of Anesthesiologists Class I) Diagnosis of acute apical periodontitis Presence of at least four posterior occlusal units (one premolar pair counted as one unit; one molar pair counted as two units) Age ≥18 years Absence of maxillofacial pathology or systemic disease No history of temporomandibular joint or masticatory muscle disorders No complaints of dysphoni No diagnosed muscular disorders
Who cannot join
- Presence of systemic disease Current use of any medication Fewer than 20 natural teeth Presence of prosthetic restorations (single crowns, fixed dental prostheses, or removable prostheses) Dental implant restorations History of periodontal treatment within the previous year Diagnosis of symptomatic pulpitis Pregnancy Smoking Unilateral edentulism
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Nezif Çelik
Karaköprü, Şanlıurfa, 63300
Harran University
Sanliurfa, Haliliye, 63300
About this study
Official title: Evaluation of the Effect of Acute Apical Periodontitis on Masseter Muscle With Elastography: A Case-control Study
In teeth that remain decayed for a long time, the muscles in that area atrophy because the patient cannot use the decayed area much. As a result, muscle length and mass decrease. To compare the amount of this reduction before and after treatment with ultrasound and to treat accordingly
Read the detailed description
Material and method Clinical examination Apical periodontitis is inflammation of the periodontium at the entry portals of the root canal system. Typically, the lesion is found at the root apex, but it can occur at various levels along the root surface, and lesions can also develop in the lateral and furcal regions Acute apical periodontitis (AAP) is characterized by acute clinical symptoms (pain with the teeth in occlusion, tenderness to percussion or palpation in the periapical region, intrasulcular/intracanal pus drainage and swelling) but no evidence of periapical radiolucency except for mild widening of the periodontal ligament.
Patients will be selected from patients who apply to the Department of Endodontics, Faculty of Dentistry, Harran University, as a result of clinical and radiological examinations for acute apical periodontitis cases. After the patients are informed about the treatments to be performed, ultrasound measurements will be performed on the patients. Ultrasound(USG) imaging procedures will be performed by a single operator. Data will be recorded. Then, under local anesthesia and rubber dam isolation, the relevant tooth will be opened with round (Intensiv212) access cavities. Working length (WL) was determined using an electronic apex locator (Root ZX II; J. Morita Corp., Kyoto, Japan) in combination with a size 10 K-file. ProTaper Next X1 (#17, 0.04 taper) and X2 (#25, 0.06 taper) files (Dentsply Sirona, Ballaigues, Switzerland) were used sequentially with an endodontic motor (VDW Silver Reciproc; VDW, Munich, Germany) using gentle in-and-out movements in accordance with the manufacturer's instructions. The canals will be irrigated with 2 ml sodium hypochlorite at each file change. final irrigation will be done with 5ml 17% EDTA (Ethylenediaminetetraacetic acid), 2.5ml DW (distilled water) and 5.25% NaOCl (sodium hypochlorite). Then, after the canals are dried, they will be filled with calcium hydroxide and kept for 14 days with glass ionomer filling. At the end of this period, the patients will be called back, the necessary checks will be done, the canals will be washed again and kept for another 14 days with calcium hydroxide. At the end of the total of 28 days, the measurements will be repeated with a second ultrasound from the patients whose symptoms have completely disappeared and before and after comparisons will be made.
USG imaging In USG evaluation, LOGIQ P9 XDclear (GE HealthCare, USA) Masseter muscle thickness measurements will assume that the part with the highest repeatability is the middle part of the mediolateral line along the mandibular ramus. Therefore, when making measurements, the "L 3-12 RS (3-12 MHz)" linear probe will be placed approximately from the region corresponding to the middle of the mediolateral line along the mandibular ramus, perpendicular to the fibers of the masseter muscle, and parallel to the long axis of the corpus mandibula, in the middle between the zygomatic arch and the gonial angle, close to the occlusal plane, which is the thickest part of the masseter muscle.
Muscle thickness was defined as the maximum distance between the inner and outer fascia. Shear wave elastography (SWE) method will be used in ultrasonographic elastography examinations of muscles. In this study, the value recorded as Young's modulus will be defined as hardness and kPa units will be used.
Masseter Muscle SWE Examination For each participant, the stiffness values of the muscles at rest and at maximum contraction will be calculated for the right and left masseter muscles. The probe will be placed at the widest part in the middle of the muscle belly, perpendicular to the long axis of the masseter muscle. In the second method, the probe will be placed at the widest part in the middle of the muscle, parallel to the long axis of the masseter muscle.
In both methods, the middle part of the masseter muscle will be determined as the most prominent part when the participant bites in the B-Mode images. Then, the width of the region to be examined will be adjusted and the "Elasto" mode will be selected and the SWE system will be activated.
With the activation of the SWE system, the screen will be divided into right and left sections, where the routine grayscale image will be displayed on the left and the elastography image will be displayed on the right. Then, three consecutive elastography images will be obtained and a 10 cm2 circular region of interest (ROI) will be placed at the center of the examined muscle tissue in each image. After three measurements are taken in this way, the average of the measurements will be taken as the stiffness value of the muscle.
- Being tested
- Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours., patients who have not acute apical periodontitis
- Keywords
- pain, masseter, muscle, ultrasonography, teeth
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours.Diagnostic test
Patients with acute apical periodontitis will first have masseter muscle measurements in the relevant area and then the decayed tooth will be treated with calcium hydroxide for 14 days. Then the dressing will be applied with calcium hydroxide again. At the end of 28 days, the patient will be measured again by ultrasonography and the initial and final data will be compared.
patients who have not acute apical periodontitisOther
Masseter measurements will be made from day 1 to day 28 in healthy subjects without acute apical periodontitis.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound group | Active comparator | Apical periodontitis' is a general term used to describe the periapical inflammatory process that occurs in response to the presence of micro-organisms and other irritants within the root canal system of a tooth. The length and mass of the masseter muscle will be measured on the first and 28th day of root canal treatment in patients with acute apical periodontitis.. Receives: Diagnostic Test: Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours. |
| sham group | Sham comparator | Masseter muscle thickness and length in healthy individuals will be measured on days 1 and 28. Receives: Other: patients who have not acute apical periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The thickness and length of the masseter muscle
Masseter muscle thickness measurements will made on the screen at the same time, with the help of the distance measurement feature of the USG device, over images of the muscles at rest and maximum contraction. masseter muscle thickness will be measured in millimeters (mm).
Measured: first week
Masseter muscle stiffness
Masseter muscle stiffness will be measured in kilopascals (Kpa)
Measured: first week
Secondary outcomes (2)
The thickness and length of the masseter muscle
Masseter muscle thickness measurements will made on the screen at the same time, with the help of the distance measurement feature of the USG device, over images of the muscles at rest and maximum contraction. masseter muscle thickness will be measured in millimeters (mm).
Measured: four weeks
Masseter muscle stiffness
Masseter muscle stiffness will be measured in kilopascals (Kpa)
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start30 Jan 2025
- Primary completion1 Nov 2025
- Study completion11 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Apical Periodontitis of Pulpal OriginStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two groups with control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezif Celik, Harran University
- Investigators
- nezif çelik, PhD, Study director, HARRAN UNİVERSTY DENTİSTRY FACULTYmehmet EMİN DOĞAN, PhD, Principal investigator, HARRAN UNİVERSTY DENTİSTRY FACULTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734559
- Sponsor's protocol ID
- HRÜ-DHF-END-NC-01
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Acute Apical Periodontitis on Masseter Muscle With Elastography: A Case-control Study
- ClinicalTrials.gov ID
- NCT06734559
- Acronym / sponsor ID
- HRÜ-DHF-END-NC-01
- Keywords
- pain, masseter, muscle, ultrasonography, teeth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 11 Mar 2026 (estimated)
- First posted
- 16 Dec 2024 (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.
In teeth that remain decayed for a long time, the muscles in that area atrophy because the patient cannot use the decayed area much. As a result, muscle length and mass decrease. To compare the amount of this reduction before and after treatment with ultrasound and to treat accordingly
Detailed description
Material and method Clinical examination Apical periodontitis is inflammation of the periodontium at the entry portals of the root canal system. Typically, the lesion is found at the root apex, but it can occur at various levels along the root surface, and lesions can also develop in the lateral and furcal regions Acute apical periodontitis (AAP) is characterized by acute clinical symptoms (pain with the teeth in occlusion, tenderness to percussion or palpation in the periapical region, intrasulcular/intracanal pus drainage and swelling) but no evidence of periapical radiolucency except for mild widening of the periodontal ligament.
Patients will be selected from patients who apply to the Department of Endodontics, Faculty of Dentistry, Harran University, as a result of clinical and radiological examinations for acute apical periodontitis cases. After the patients are informed about the treatments to be performed, ultrasound measurements will be performed on the patients. Ultrasound(USG) imaging procedures will be performed by a single operator. Data will be recorded. Then, under local anesthesia and rubber dam isolation, the relevant tooth will be opened with round (Intensiv212) access cavities. Working length (WL) was determined using an electronic apex locator (Root ZX II; J. Morita Corp., Kyoto, Japan) in combination with a size 10 K-file. ProTaper Next X1 (#17, 0.04 taper) and X2 (#25, 0.06 taper) files (Dentsply Sirona, Ballaigues, Switzerland) were used sequentially with an endodontic motor (VDW Silver Reciproc; VDW, Munich, Germany) using gentle in-and-out movements in accordance with the manufacturer's instructions. The canals will be irrigated with 2 ml sodium hypochlorite at each file change. final irrigation will be done with 5ml 17% EDTA (Ethylenediaminetetraacetic acid), 2.5ml DW (distilled water) and 5.25% NaOCl (sodium hypochlorite). Then, after the canals are dried, they will be filled with calcium hydroxide and kept for 14 days with glass ionomer filling. At the end of this period, the patients will be called back, the necessary checks will be done, the canals will be washed again and kept for another 14 days with calcium hydroxide. At the end of the total of 28 days, the measurements will be repeated with a second ultrasound from the patients whose symptoms have completely disappeared and before and after comparisons will be made.
USG imaging In USG evaluation, LOGIQ P9 XDclear (GE HealthCare, USA) Masseter muscle thickness measurements will assume that the part with the highest repeatability is the middle part of the mediolateral line along the mandibular ramus. Therefore, when making measurements, the "L 3-12 RS (3-12 MHz)" linear probe will be placed approximately from the region corresponding to the middle of the mediolateral line along the mandibular ramus, perpendicular to the fibers of the masseter muscle, and parallel to the long axis of the corpus mandibula, in the middle between the zygomatic arch and the gonial angle, close to the occlusal plane, which is the thickest part of the masseter muscle.
Muscle thickness was defined as the maximum distance between the inner and outer fascia. Shear wave elastography (SWE) method will be used in ultrasonographic elastography examinations of muscles. In this study, the value recorded as Young's modulus will be defined as hardness and kPa units will be used.
Masseter Muscle SWE Examination For each participant, the stiffness values of the muscles at rest and at maximum contraction will be calculated for the right and left masseter muscles. The probe will be placed at the widest part in the middle of the muscle belly, perpendicular to the long axis of the masseter muscle. In the second method, the probe will be placed at the widest part in the middle of the muscle, parallel to the long axis of the masseter muscle.
In both methods, the middle part of the masseter muscle will be determined as the most prominent part when the participant bites in the B-Mode images. Then, the width of the region to be examined will be adjusted and the "Elasto" mode will be selected and the SWE system will be activated.
With the activation of the SWE system, the screen will be divided into right and left sections, where the routine grayscale image will be displayed on the left and the elastography image will be displayed on the right. Then, three consecutive elastography images will be obtained and a 10 cm2 circular region of interest (ROI) will be placed at the center of the examined muscle tissue in each image. After three measurements are taken in this way, the average of the measurements will be taken as the stiffness value of the muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups with control
| Arm | Type | Receives |
|---|---|---|
| ultrasound group | Active comparator | Diagnostic Test: Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours.Apical periodontitis' is a general term used to describe the periapical inflammatory process that occurs in response to the presence of micro-organisms and other irritants within the root canal system of a tooth. The length and mass of the masseter muscle will be measured on the first and 28th day of root canal treatment in patients with acute apical periodontitis.. |
| sham group | Sham comparator | Other: patients who have not acute apical periodontitisMasseter muscle thickness and length in healthy individuals will be measured on days 1 and 28. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Systemically healthy adults aged 18-65 years (American Society of Anesthesiologists Class I) Diagnosis of acute apical periodontitis Presence of at least four posterior occlusal units (one premolar pair counted as one unit; one molar pair counted as two units) Age ≥18 years Absence of maxillofacial pathology or systemic disease No history of temporomandibular joint or masticatory muscle disorders No complaints of dysphoni No diagnosed muscular disorders
Key exclusion criteria (1 listed)
- Presence of systemic disease Current use of any medication Fewer than 20 natural teeth Presence of prosthetic restorations (single crowns, fixed dental prostheses, or removable prostheses) Dental implant restorations History of periodontal treatment within the previous year Diagnosis of symptomatic pulpitis Pregnancy Smoking Unilateral edentulism
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 |
|---|---|---|
| Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours.Patients with acute apical periodontitis will first have masseter muscle measurements in the relevant area and then the decayed tooth will be treated with calcium hydroxide for 14 days. Then the dressing will be applied with calcium hydroxide again. At the end of 28 days, the patient will be measured again by ultrasonography and the initial and final data will be compared. | Diagnostic test | ultrasound group |
| patients who have not acute apical periodontitisMasseter measurements will be made from day 1 to day 28 in healthy subjects without acute apical periodontitis. | Other | sham group |
Primary outcome
The thickness and length of the masseter muscle
Time frame: first week
Masseter muscle thickness measurements will made on the screen at the same time, with the help of the distance measurement feature of the USG device, over images of the muscles at rest and maximum contraction. masseter muscle thickness will be measured in millimeters (mm).
Masseter muscle stiffness
Time frame: first week
Masseter muscle stiffness will be measured in kilopascals (Kpa)
2 secondary outcomes
The thickness and length of the masseter muscle
Time frame: four weeks
Masseter muscle stiffness
Time frame: four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Apical Periodontitis of Pulpal Origin
Not yet recruiting
Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
Chronic Apical Periodontitis, Necrosis of Pulp
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.
nezif çelik, PhD study director
HARRAN UNİVERSTY DENTİSTRY FACULTY
mehmet EMİN DOĞAN, PhD principal investigator
HARRAN UNİVERSTY DENTİSTRY FACULTY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients who have not antibiotic treatment for acute apical periodontitis in the last month and have not taken any anti-inflammatory medication in the past 24 hours. and patients who have not acute apical periodontitis in people with Acute Apical Periodontitis of Pulpal Origin, run by Harran University at 2 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
The thickness and length of the masseter muscle (time frame: first week). The study lists 2 primary outcomes in all. 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 13 Mar 2026.