Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-03-03 @ 3:09 PM
Study NCT ID:
NCT06853028
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2025-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasonography', 'timeFrame': 'immediately before root canal treatment, 1 week after and 3 months after the treatment', 'description': '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.\n\nAsymmetry Index = \\[(Control Side - Painful Side) / (Control Side + Painful Side)\\] × 100'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['root canal treatment', 'ultrasonography', 'endodontic pain', 'acute apical periodontitis', 'masticatory laterality'], 'conditions': ['Temporomandibular Disorders (TMD)', 'Acute Apical Periodontitis of Pulpal Origin']}, 'referencesModule': {'references': [{'pmid': '35028733', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28861285', 'type': 'BACKGROUND', 'citation': 'Jeon 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.'}, {'pmid': '37021602', 'type': 'BACKGROUND', 'citation': 'Daline 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.'}, {'pmid': '40726276', 'type': 'DERIVED', 'citation': 'Gurler 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 Jul 29. doi: 10.1111/aej.12979. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nCan bilateral chewing function be restored after root canal treatment procedures in patients with masticatory laterality due to painful teeth due to acute apical periodontitis?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '•. 20 systemically healthy patients (11 female, 9 male) aged 18-60 years\n\n* Patients with masticatory laterality due to tooth pain for at least 30 days\n* First and second maxillary or mandibular molars with acute apical periodontitis due to deep caries\n* 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))\n* Teeth that responded positively to percussion test\n* Teeth without periapical pathosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients with masticatory laterality due to tooth pain for at least 30 days\n* First and second maxillary or mandibular molars with acute apical periodontitis due to deep caries\n* 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))\n* Teeth that responded positively to percussion test\n* Teeth without periapical pathosis were included in the study. Exclusion Criteria\n* Systemic conditions affecting muscle structure or function, such as neuromuscular or endocrine disorders.\n* Non-endodontic odontogenic pain.\n* Prior endodontic treatment of the relevant tooth within the last 30 days.\n* History of trauma or surgery to the head, face, or teeth within the last six months.\n* Severe communication disorders or psychological issues.\n* Inability to complete treatment in a single visit due to exudation or bleeding\n* Patients with masticatory laterality due to missing tooth on any side of the dental arch\n* Patients who have painful teeth in opposite sides of the dental arch\n* TMD patients were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06853028', 'briefTitle': 'The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'The Role of Root Canal Treatment in Alleviating Endodontic Pain-Induced Asymmetry and Restoring Muscle Balance: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': '10.05.2024/144'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a masticatory laterality due to acute apical periodontitis', 'interventionNames': ['Other: ultrasound measurement']}], 'interventions': [{'name': 'ultrasound measurement', 'type': 'OTHER', 'description': 'Muscle thickness measurements were performed with the ultrasound device immediately before root canal treatment, 1 week after, and 3 months after the treatment.', 'armGroupLabels': ['Patients with a masticatory laterality due to acute apical periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01250', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS MSc', 'investigatorFullName': 'Kübra Gürler', 'investigatorAffiliation': 'Cukurova University'}}}}