Effect of Anterior Disc Displacement With Reduction on Postoperative Pain After Root Canal Treatment

NCT07329413 | Completed

• 1 other identifier: 2025/82
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the impact of anterior disc displacement with reduction (ADDR) on postoperative pain following root canal treatment in patients diagnosed with symptomatic apical periodontitis.

Conditions

Anterior Disc Displacement; Symptomatic Apical Periodontitis; Temporomandibular Disorders (TMDs)

Keywords

Endodontics; Postoperative pain; Root Canal Therapy; Temporomandibular Joint; Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  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.

  6, 12 hours 1, 2, 3, 5 and 7 days postoperatively

Secondary Outcomes (2)

• Maximum mouth opening

  Baseline and 7 days postoperatively

• Temporomandibular joint pain and percussion sensitivity

  Baseline and 7 days postoperatively

Study Arms (2)

ADDR group

EXPERIMENTAL

Patients diagnosed with anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders.

Procedure: Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold); Drug: Ibuprofen 400 mg (if necessary)

Control group

ACTIVE COMPARATOR

Patients without any temporomandibular joint pathology.

Procedure: Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold); Drug: Ibuprofen 400 mg (if necessary)

Interventions

Ibuprofen 400 mg (if necessary) DRUG

Ibuprofen (oral analgesic) was prescribed to all patients who underwent root canal treatment and was recommended for use only in case of postoperative pain.

ADDR group; Control group

Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold) PROCEDURE

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.

ADDR group; Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Rize Province, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain, Postoperative

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Edanur Maraş, DDS, PhD

  Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Endodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An oral diagnosis and radiology specialist with more than 10 years of clinical experience evaluated the patients' endodontic treatment needs and performed the temporomandibular joint examination. Patients diagnosed with anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders were assigned to the experimental group, while individuals without temporomandibular joint disorders constituted the control group. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were assigned to one of two parallel groups based on the presence or absence of anterior disc displacement with reduction. Both groups received root canal treatment using the same standardized clinical protocol, and outcomes were evaluated in parallel.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 9, 2026
• Study Start: March 10, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 14, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)