Symptomatic Apical PeriodontitisTMD-POSTOPNCT07329413

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

A study testing Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold) and Ibuprofen 400 mg (if necessary) in people with Symptomatic Apical Periodontitis and Temporomandibular Disorders (TMDs), run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Symptomatic Apical Periodontitis, Temporomandibular Disorders (TMDs), Anterior Disc Displacement
What is being tested?: Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold) and Ibuprofen 400 mg (if necessary)
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 10 Mar 2025to 14 Jul 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Recep Tayyip Erdoğan University Faculty of Dentistry
Rize, Rize Province

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Conditions: Symptomatic Apical Periodontitis, Temporomandibular Disorders (TMDs), Anterior Disc Displacement
Being tested: Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold), Ibuprofen 400 mg (if necessary)
Keywords: Endodontics, Postoperative pain, Root Canal Therapy, Temporomandibular Joint, Temporomandibular Joint Disorders
Medical subject headings: Temporomandibular Joint Disorders, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07329413
Study group	Role	What they receive
ADDR group	Experimental	Patients diagnosed with anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders. Receives: 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. Receives: Procedure: Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold); Drug: Ibuprofen 400 mg (if necessary)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Maximum mouth opening
Maximum mouth opening was measured in millimeters using a digital caliper during the preoperative examination and at the 7-day postoperative follow-up.
Measured: Baseline and 7 days postoperatively
Temporomandibular joint pain and percussion sensitivity
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.
Measured: Baseline and 7 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202514 Jul 2025

First posted9 Jan 2026
Study start10 Mar 2025
Primary completion1 Jul 2025
Study completion14 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Symptomatic Apical PeriodontitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07329413
Sponsor's protocol ID: 2025/82
Other IDs: 2025/82
Acronym: TMD-POSTOP
Status last verified: Dec 2025
First submitted: 15 Dec 2025
Last updated: 9 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared.

Publications

Revi B, Maras E, Naralan ME. Does Anterior Disc Displacement with Reduction Affect Postoperative Pain Perception After Root Canal Therapy? A Prospective Comparative Clinical Study. Diagnostics (Basel). 2026 Jun 26;16(13):1998. doi: 10.3390/diagnostics16131998.
PubMed 42449780

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruiting
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Endodontically Treated Teeth, Calcium Hydroxide
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis

All Symptomatic Apical Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07329413
Acronym / sponsor ID: TMD-POSTOP / 2025/82
Conditions: Symptomatic Apical Periodontitis, Temporomandibular Disorders (TMDs), Anterior Disc Displacement
Keywords: Endodontics, Postoperative pain, Root Canal Therapy, Temporomandibular Joint, Temporomandibular Joint Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Recep Tayyip Erdogan UniversityUniversity, hospital or other
Study start: 10 Mar 2025 (actual)
Primary completion: 1 Jul 2025 (actual)
Study completion: 14 Jul 2025 (actual)
First posted: 9 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
ADDR group	Experimental	Procedure: Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold), Drug: Ibuprofen 400 mg (if necessary)Patients diagnosed with anterior disc displacement with reduction according to the Diagnostic Criteria for Temporomandibular Disorders.
Control group	Active comparator	Procedure: Single-Visit Conventional Root Canal Treatment Using Nickel-Titanium Rotary Instruments (Endoart Smart Gold), Drug: Ibuprofen 400 mg (if necessary)Patients without any temporomandibular joint pathology.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Procedure or surgery	ADDR group, Control group
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.	Drug	ADDR group, Control group

Primary outcome

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.

2 secondary outcomes

Maximum mouth opening
Time frame: Baseline and 7 days postoperatively
Temporomandibular joint pain and percussion sensitivity
Time frame: Baseline and 7 days postoperatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
Derived from this study: PubMed 42449780Revi B, Maras E, Naralan ME. Does Anterior Disc Displacement with Reduction Affect Postoperative Pain Perception After Root Canal Therapy? A Prospective Comparative Clinical Study. Diagnostics (Basel). 2026 Jun 26;16(13):1998. doi: 10.3390/diagnostics16131998.
Individual participant dataSharing planned: No. Individual participant data will not be shared.

Related trials for Symptomatic Apical Periodontitis

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruiting
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Endodontically Treated Teeth, Calcium Hydroxide
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edanur Maraş, DDS, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain intensity (time frame: 6, 12 hours 1, 2, 3, 5 and 7 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07329413, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.