NCT07237620 The Effect of Different Intracanal Medicaments on Periapical Lesion Healing
| NCT ID | NCT07237620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mustafa Kemal University |
| Condition | Periapical Lesion Healing |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-15 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is planned to evaluate the effects of two different intracanal medicaments-calcium hydroxide and diclofenac sodium-on periapical healing following endodontic retreatment. Fifty-four patients will be included and randomly assigned into two groups according to the type of medicament used. All procedures will be performed by a single experienced endodontist under standardized clinical conditions. Periapical lesion healing will be assessed radiographically at baseline and after 12 months using fractal analysis to quantitatively evaluate bone regeneration. The primary outcome will be the change in the fractal dimension values between the initial and follow-up radiographs.
Eligibility Criteria
Inclusion Criteria: The study is planned to include patients aged 18-60 years who are systemically healthy (ASA I-II), present with apical periodontitis after primary root canal treatment, and have single-rooted, root-filled mandibular teeth with a periapical index (PAI) score of ≥3. Endodontic treatment failure is to be evaluated based on clinical and radiographic examinations. The duration of the initial endodontic treatment is to be at least four years or longer and/or the teeth are to exhibit clinical symptoms and signs. Previous root canal fillings are to be assessed for obturation quality and classified as satisfactory if they meet the following criteria: no visible voids, good condensation, and termination within 1-2 mm of the radiographic apex. If one or more of these criteria are not fulfilled, the obturation is to be classified as poor quality. The presence of post-treatment apical periodontitis, poor obturation quality, and/or persistent or newly developed symptoms (such as spontaneous pain, tenderness to palpation or percussion) and/or sinus tract formation are to be considered as indications for retreatment. Exclusion Criteria: Patients with a history of psychiatric disorders, allergic reactions, or pregnancy, and those who have taken analgesics within seven days prior to treatment or antibiotics within the previous three months, are to be excluded from the study. Teeth presenting with a periodontal pocket depth greater than 4 mm, severe coronal destruction preventing rubber dam placement, vertical root fracture, internal or external resorption, ankylosis, overfilling, open apex, or that have undergone surgical or nonsurgical retreatment after primary therapy are to be excluded. Teeth with perforation or fractured instruments are also to be excluded.
Contact & Investigator
Merve Sarı, DDS,MSc
PRINCIPAL INVESTIGATOR
Mustafa Kemal University Hatay, Turkey
Frequently Asked Questions
Who can join the NCT07237620 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Periapical Lesion Healing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07237620 currently recruiting?
Yes, NCT07237620 is actively recruiting participants. Contact the research team at sarimerve94@outlook.com for enrollment information.
Where is the NCT07237620 trial being conducted?
This trial is being conducted at Hatay, Turkey (Türkiye).
Who is sponsoring the NCT07237620 clinical trial?
NCT07237620 is sponsored by Mustafa Kemal University. The principal investigator is Merve Sarı, DDS,MSc at Mustafa Kemal University Hatay, Turkey. The trial plans to enroll 60 participants.