Chronic Apical PeriodontitisNCT07480226

Single Versus Multiple Visits Regenerative Endodontics in Mature Teeth

A study testing Single-Visit Regenerative Endodontic Treatment and Multiple-Visit Regenerative Endodontic Treatment in people with Chronic Apical Periodontitis, run by Marmara 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

Search all trials

Trial summary

The goal of this clinical trial is to learn whether regenerative endodontic treatment (RET) should be performed in one visit or two visits in people with mature permanent teeth with chronic apical periodontitis. RET is a dental treatment used for teeth with necrotic pulp and infection around the root. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Chronic Apical Periodontitis
What is being tested?: Single-Visit Regenerative Endodontic Treatment and Multiple-Visit Regenerative Endodontic Treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Sep 2024to 30 Jan 2026
Phase: Interventional

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 40 years
All sexes
No healthy volunteers
Adult

Inclusion Criteria The inclusion criteria for this study were defined as follows: individuals aged between 18 and 40 years who were classified as ASA I (systemically healthy) according to the American Society of Anesthesiologists (ASA) classification; mature permanent teeth with completed root development (closed apex); single-rooted and single-canal maxillary central or lateral incisors; teeth that had not received previous endodontic treatment; teeth diagnosed with chronic apical periodontitis and presenting with a lesion with a periapical index (PAI) score ≥3 according to the classification; teeth that were asymptomatic in the preoperative clinical evaluation; teeth that were restorable and did not require post or core placement for permanent restoration; and patients who signed the informed consent form to participate in the study.

Exclusion Criteria The exclusion criteria were as follows: individuals younger than 18 years or older than 40 years; patients with systemic diseases classified as ASA II or higher according to the ASA classification; pregnant or breastfeeding women; teeth with root fractures or internal or external root resorption; and teeth presenting with advanced periodontal destruction, pathological periodontal pocket depth ≥3 mm, or mobility greater than Grade 1.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Marmara University Faculty of Dentistry
Istanbul, Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Postoperative Pain and Healing Outcomes After Single Versus Multiple Visits Regenerative Endodontic Treatment in Mature Teeth With Chronic Apical Periodontitis: A Randomized Clinical Trial

RET is a dental treatment used for teeth with necrotic pulp and infection around the root. The procedure disinfects the root canal and promotes the formation of new tissue inside the canal space, which may support healing of the tissues around the tooth root.

The main questions this study aims to answer are:

Does single-visit RET cause different levels of postoperative pain compared with two-visit RET? Do teeth treated with single-visit or two-visit RET show different levels of healing around the root? Participants will receive RET using either a single-visit or two-visit treatment protocol. Participants will record their pain levels during the first week after treatment using a visual analog scale (VAS). Participants will return for follow-up visits at six months and one year, when dental radiographs will be taken to evaluate healing around the tooth root.

Conditions: Chronic Apical Periodontitis
Being tested: Single-Visit Regenerative Endodontic Treatment, Multiple-Visit Regenerative Endodontic Treatment

What participants receive

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

Single-Visit Regenerative Endodontic TreatmentProcedure or surgery
Regenerative endodontic treatment was performed in a single clinical visit in mature permanent teeth diagnosed with chronic apical periodontitis. During the procedure, the root canal system was cleaned through chemomechanical preparation using mechanical instrumentation and irrigation solutions. Apical bleeding was then induced to create a biological scaffold within the canal space. A mineral trioxide aggregate (MTA) coronal barrier was placed over the blood clot. After the setting of MTA, the access cavity was restored with a definitive coronal restoration the following day.
Multiple-Visit Regenerative Endodontic TreatmentProcedure or surgery
Regenerative endodontic treatment was performed in multiple clinical visits in mature permanent teeth diagnosed with chronic apical periodontitis. During the first visit, the root canal system was cleaned through chemomechanical preparation using mechanical instrumentation and irrigation solutions, and an intracanal medicament was placed. At the second visit, the intracanal medicament was removed and apical bleeding was induced to create a biological scaffold within the canal space. MTA coronal barrier was placed over the blood clot. After the setting of MTA, the access cavity was restored with a definitive coronal restoration the following day.

Study groups in NCT07480226
Study group	Role	What they receive
Single-Visit RET	Experimental	Not described Receives: Procedure: Single-Visit Regenerative Endodontic Treatment
Multiple-Visit RET	Experimental	Not described Receives: Procedure: Multiple-Visit Regenerative Endodontic Treatment

What is being measured

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

Primer success
Primary success is defined as the absence of clinical symptoms and evidence of periapical healing on radiographs.
Measured: 12 months
Secondary success
Positive response to electric pulp testing is assessed.
Measured: 12 months

Secondary outcomes (4)

Postoperative Pain
Postoperative pain is assessed using a visual analog scale (VAS), and overall pain is calculated using the area under the curve (AUC) of VAS scores.
Measured: 8 hours, 24 hours, 48 hours, and 7 days after each treatment visit
Periapical Lesion Area
Changes in periapical lesion area are assessed using digital radiographic analysis.
Measured: Baseline and 12 months
Mean Gray Value
Changes in bone density in the periapical region are assessed using mean gray value measurements obtained from digital radiographs.
Measured: Baseline and 12 months
Fractal Dimension
Changes in trabecular bone microarchitecture in the periapical region are assessed using fractal dimension analysis.
Measured: Baseline and 12 months

Timeline

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

1 Sep 202430 Jan 2026

First posted18 Mar 2026
Study start1 Sep 2024
Primary completion30 Jan 2026
Study completion30 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07480226
Sponsor's protocol ID: 2024/13/878
Status last verified: Mar 2026
First submitted: 13 Mar 2026
Last updated: 18 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.
PubMed 35030270
Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.
PubMed 31155298

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 Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
Active, not recruiting
Effects of Irrigation Activation Methods on Periapical Healing in Chronic Apical Periodontitis
Chronic Apical Periodontitis
Not yet recruiting
Regenerative Endodontics in Mature Necrotic Teeth
Necrotic Teeth With Chronic Apical Periodontitis
Active, not recruitingObservational study
The Aim of This Study is to Evaluate the Relationship Between Genetic Polymorphisms and Periapical Lesion Healing in Individuals With Chronic Apical Periodontitis at Clinical and Radiological Levels.
Chronic Apical Periodontitis
Recruiting
In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers
Chronic Apical Periodontitis

All Chronic Apical Periodontitis trials