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Completed

NCT Number: NCT07480226

Single Versus Multiple Visits Regenerative Endodontics in Mature Teeth

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. 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.

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Key information

Conditions

Chronic Apical Periodontitis

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single-Visit Regenerative Endodontic Treatment

Procedure

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 Treatment

Procedure

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.

Primary outcomes

  1. Primer success

    Time frame: 12 months

    Primary success is defined as the absence of clinical symptoms and evidence of periapical healing on radiographs.

  2. Secondary success

    Time frame: 12 months

    Positive response to electric pulp testing is assessed.

Secondary outcomes

  1. Postoperative Pain

    Time frame: 8 hours, 24 hours, 48 hours, and 7 days after each treatment visit

    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.

  2. Periapical Lesion Area

    Time frame: Baseline and 12 months

    Changes in periapical lesion area are assessed using digital radiographic analysis.

  3. Mean Gray Value

    Time frame: Baseline and 12 months

    Changes in bone density in the periapical region are assessed using mean gray value measurements obtained from digital radiographs.

  4. Fractal Dimension

    Time frame: Baseline and 12 months

    Changes in trabecular bone microarchitecture in the periapical region are assessed using fractal dimension analysis.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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