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NCT Number: NCT07466433

Apical Preparation Size in Regenerative Endodontics of Mature Teeth

The goal of this clinical trial is to learn whether the size of apical preparation affects the success of regenerative endodontic treatment in mature permanent teeth with apical periodontitis. Regenerative endodontic treatment is a procedure that aims to eliminate infection and support healing of the tissues around the root of the tooth.

The main questions the study aims to answer are:

* Does a larger apical preparation improve healing around the root tip? * Does apical preparation size affect pain after treatment or recovery of tooth vitality?

Researchers compared two treatment approaches that use different apical preparation sizes to see if one leads to better clinical and radiographic healing.

Participants:

* Received regenerative endodontic treatment with one of two apical preparation sizes * Attended follow-up visits for clinical examination and radiographic evaluation * Were monitored for pain and healing outcomes during the follow-up period

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Key information

Conditions

Apical Periodontitis Jaw Diseases Mature Teeth Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Regenerative Endodontic Treatment Stomatognathic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Faculty of Dentistry, Department of Endodontics

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Single-rooted mature teeth with periapical lesions
  • Teeth with a PAI score ≥ 3
  • Patients aged 18-45 years
  • Systemically healthy individuals
  • Patients who provided written informed consent

Exclusion criteria

  • Immature teeth
  • Previously root canal treated teeth
  • Teeth with a PAI score <3
  • Developmental anomalies
  • Advanced periodontal destruction
  • Internal/external resorption
  • History of trauma
  • Patients with systemic diseases
  • Pregnant or breastfeeding patients

Treatment and study plan

Regenerative Endodontic Treatment

Procedure

Regenerative endodontic treatment (RET) is a biologically based procedure that includes root canal disinfection followed by placement of a biological scaffold to support tissue regeneration and periapical healing. In this study, the intervention differs according to the apical preparation size used (ISO 40 and ISO 80) in mature teeth with apical periodontitis.

Primary outcomes

  1. Primer success

    Time frame: 6 months and 12 months

    Primer success is evaluated based on the absence of clinical symptoms and radiographic healing of the periapical lesion.

  2. Secondary success

    Time frame: 6 months and 12 months

    Secondary success was defined as the recovery of pulp sensibility, evaluated using cold and electric pulp tests during follow-up examinations.

Secondary outcomes

  1. Postoperative Pain

    Time frame: baseline, day 1, day 2, and day 7 after treatment

    Postoperative pain was evaluated using a visual analogue scale.

  2. Periapical Lesion Area

    Time frame: Baseline, 6 months, 12 months

    Changes in the periapical lesion area were measured using digital radiographic analysis.

  3. Mean Gray Value

    Time frame: Baseline, 6 months, 12 months

    Bone density changes in the periapical region were evaluated using mean gray value measurements obtained from digital radiographs.

  4. Fractal Dimension

    Time frame: Baseline, 6 months, 12 months

    Changes in trabecular bone microarchitecture in the periapical region were evaluated using fractal dimension analysis.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Effect of Apical Preperation Size on the Success of Regenerative Endodontic Treatment in Mature Teeth With Apical Periodontitis: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2026
Registry last updated
Mar 12, 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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