- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329413
Effect of Anterior Disc Displacement With Reduction on Postoperative Pain After Root Canal Treatment (TMD-POSTOP)
Does Anterior Disc Displacement With Reduction Affect Postoperative Pain After Root Canal Treatment in Patients With Symptomatic Apical Periodontitis? A Prospective, Quasi-Experimental Controlled Study
Study Overview
Status
Conditions
Detailed Description
This prospective clinical study included individuals diagnosed with symptomatic apical periodontitis who had a vital mandibular molar tooth and were diagnosed with anterior disc displacement with reduction (ADDR) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) (n = 45), as well as individuals without any temporomandibular joint pathology (n = 45). Following patient dropouts, a total of 70 patients with complete and eligible data were included in the final analysis, with 35 participants in each group.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rize Province
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Rize, Rize Province, Turkey (Türkiye)
- Recep Tayyip Erdogan University Faculty of Dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged between 18 and 65 years with no systemic disease
- 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:
- Teeth found to have necrotic pulp tissue during access cavity preparation
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ADDR group
Patients diagnosed with anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders.
|
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 (oral analgesic) was prescribed to all patients who underwent root canal treatment and was recommended for use only in case of postoperative pain.
|
|
Active Comparator: Control group
Patients without any temporomandibular joint pathology.
|
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 (oral analgesic) was prescribed to all patients who underwent root canal treatment and was recommended for use only in case of postoperative pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity
Time Frame: 6, 12 hours 1, 2, 3, 5 and 7 days postoperatively
|
To evaluate postoperative pain, each patient was provided with a pain diary after root canal treatment and was instructed to record pain intensity using the Numeric Rating Scale (NRS).
Detailed instructions on how to use the NRS were given to all participants.
Pain intensity was recorded at 6, 12, 24, 48, and 72 hours and at 5 and 7 days after treatment.
Patients were prescribed 400 mg ibuprofen for use only in cases of severe pain.
Data from patients who used analgesics during the follow-up period were excluded from the analysis.
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6, 12 hours 1, 2, 3, 5 and 7 days postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum mouth opening
Time Frame: Baseline and 7 days postoperatively
|
Maximum mouth opening was measured in millimeters using a digital caliper during the preoperative examination and at the 7-day postoperative follow-up.
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Baseline and 7 days postoperatively
|
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Temporomandibular joint pain and percussion sensitivity
Time Frame: Baseline and 7 days postoperatively
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Temporomandibular joint pain and percussion sensitivity of the treated tooth were evaluated using the Numeric Rating Scale during the preoperative period and at the 7-day postoperative follow-up.
|
Baseline and 7 days postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edanur Maraş, DDS, PhD, Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Endodontics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Muscular Diseases
- Postoperative Complications
- Pathologic Processes
- Joint Diseases
- Jaw Diseases
- Mandibular Diseases
- Craniomandibular Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Temporomandibular Joint Disorders
- Organic Chemicals
- Carboxylic Acids
- Acids, Carbocyclic
- Phenylpropionates
- Ibuprofen
Other Study ID Numbers
- 2025/82 (Other Identifier: Recep Tayyip Erdoğan University Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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