Effect of Anterior Disc Displacement With Reduction on Postoperative Pain After Root Canal Treatment
NCT ID: NCT07329413
Last Updated: 2026-01-09
Study Results
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Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2025-03-10
2025-07-14
Brief Summary
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Detailed Description
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All root canal treatments were performed by the same clinician using a standardized treatment protocol. Postoperative pain intensity was assessed using the Numeric Rating Scale at 6 and 12 hours and at 1, 2, 3, 5, and 7 days after treatment. In addition, joint sounds, joint pain, and maximum mouth opening were recorded in the preoperative period and at the 7-day postoperative follow-up, and their associations with postoperative pain were analyzed.
The findings of this study provide insight into the relationship between temporomandibular joint disorders and endodontic postoperative pain and may contribute to improved clinical understanding.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
At this stage, both the participants and the clinician performing the root canal treatments were blinded to the temporomandibular joint status of the patients (double-blind). Group allocation was concealed until completion of the data analysis, resulting in a triple-blind study design.
Study Groups
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ADDR group
Patients diagnosed with anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders.
Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold)
All endodontic treatments were performed in a single visit by a single operator (BR) with six years of clinical experience, using a standardized treatment protocol. Only one tooth per patient was included in the study. Inferior alveolar nerve block anesthesia was administered. After rubber dam isolation, access cavities were prepared. Working length was determined using an electronic apex locator set at 0.5 mm short of the apical foramen and confirmed with periapical radiography. Root canals were prepared using Endoart Smart Gold rotary instruments (Inci Dental, Istanbul, Türkiye) up to size 25/.04 for mesial canals and 30/.04 for distal canals. If insufficient apical instrumentation was detected, canal enlargement was extended up to a maximum of two sizes larger, according to canal length and anatomy. Following canal preparation, final irrigation was performed. The canals were obturated using the lateral condensation technique with a resin-based root canal sealer.
Ibuprofen 400 mg (if necessary)
Ibuprofen (oral analgesic) was prescribed to all patients who underwent root canal treatment and was recommended for use only in case of postoperative pain.
Control group
Patients without any temporomandibular joint pathology.
Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold)
All endodontic treatments were performed in a single visit by a single operator (BR) with six years of clinical experience, using a standardized treatment protocol. Only one tooth per patient was included in the study. Inferior alveolar nerve block anesthesia was administered. After rubber dam isolation, access cavities were prepared. Working length was determined using an electronic apex locator set at 0.5 mm short of the apical foramen and confirmed with periapical radiography. Root canals were prepared using Endoart Smart Gold rotary instruments (Inci Dental, Istanbul, Türkiye) up to size 25/.04 for mesial canals and 30/.04 for distal canals. If insufficient apical instrumentation was detected, canal enlargement was extended up to a maximum of two sizes larger, according to canal length and anatomy. Following canal preparation, final irrigation was performed. The canals were obturated using the lateral condensation technique with a resin-based root canal sealer.
Ibuprofen 400 mg (if necessary)
Ibuprofen (oral analgesic) was prescribed to all patients who underwent root canal treatment and was recommended for use only in case of postoperative pain.
Interventions
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Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold)
All endodontic treatments were performed in a single visit by a single operator (BR) with six years of clinical experience, using a standardized treatment protocol. Only one tooth per patient was included in the study. Inferior alveolar nerve block anesthesia was administered. After rubber dam isolation, access cavities were prepared. Working length was determined using an electronic apex locator set at 0.5 mm short of the apical foramen and confirmed with periapical radiography. Root canals were prepared using Endoart Smart Gold rotary instruments (Inci Dental, Istanbul, Türkiye) up to size 25/.04 for mesial canals and 30/.04 for distal canals. If insufficient apical instrumentation was detected, canal enlargement was extended up to a maximum of two sizes larger, according to canal length and anatomy. Following canal preparation, final irrigation was performed. The canals were obturated using the lateral condensation technique with a resin-based root canal sealer.
Ibuprofen 400 mg (if necessary)
Ibuprofen (oral analgesic) was prescribed to all patients who underwent root canal treatment and was recommended for use only in case of postoperative pain.
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with symptomatic apical periodontitis
* Presence of a vital permanent mandibular first or second molar tooth requiring root canal treatment
* Teeth with no radiographic evidence of periapical changes or only slight widening of the periodontal ligament space
* Patients reporting preoperative spontaneous pain with a Numeric Rating Scale (NRS) score between 4 and 10 (moderate pain: 4-6; severe pain: 7-10)
* Patients reporting pain intensity of 4 or higher on the NRS during percussion testing
* Patients diagnosed with isolated anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) (experimental group) or patients without any temporomandibular joint disorder or pathology (control group)
Exclusion Criteria
* Patients in whom the study tooth was not located on the same side as the temporomandibular joint diagnosed with anterior disc displacement with reduction
* Occurrence of any endodontic complications during treatment
* Use of medications that could affect pain perception (e.g., analgesics or anti-inflammatory drugs) within at least 12 hours before treatment, or use of systemic antibiotics within one month prior to enrollment
* History of major jaw trauma, dentofacial deformities, or previous temporomandibular joint surgery
* Concurrent use of steroids, muscle relaxants, or narcotic medications
* History of diagnosed neuropathic pain, myofascial pain, neuralgic pain, or chronic headache disorders
* Presence of periodontal disease (probing depth \> 5 mm or tooth mobility greater than Grade I) or teeth lacking adequate coronal structure
* Teeth without occlusal contact or with premature contacts, patients with bruxism or clenching habits, or patients with fewer than three teeth on one side of the mandible
* Inability to read, understand, or complete the pain assessment scale or to provide the required follow-up data
* Presence of significant cognitive impairment (e.g., communication deficits, intellectual disability) or diagnosed psychiatric disorders (e.g., depression, anxiety disorders)
* Presence of immature teeth or teeth with open apices
* Pregnant or breastfeeding women
18 Years
65 Years
ALL
No
Sponsors
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Recep Tayyip Erdogan University
OTHER
Responsible Party
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burcu revi
Principal Investigator
Principal Investigators
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Edanur Maraş, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Endodontics
Locations
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Recep Tayyip Erdoğan University Faculty of Dentistry
Rize, Rize Province, Turkey (Türkiye)
Countries
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Other Identifiers
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2025/82
Identifier Type: OTHER
Identifier Source: secondary_id
2025/82
Identifier Type: -
Identifier Source: org_study_id
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