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

NCT ID: NCT07329413

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-07-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Symptomatic Apical Periodontitis Temporomandibular Disorders (TMDs) Anterior Disc Displacement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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ADDR group

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Ibuprofen 400 mg (if necessary)

Intervention Type 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.

Control group

Patients without any temporomandibular joint pathology.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Ibuprofen 400 mg (if necessary)

Intervention Type 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.

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.

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Recep Tayyip Erdogan University

OTHER

Sponsor Role lead

Responsible Party

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burcu revi

Principal Investigator

Responsibility Role 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)

Site Status

Countries

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Turkey (Türkiye)

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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