Apical Periodontitis, Mature Teeth, Regenerative Endodontic Treatment
Conditions
Brief summary
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
Interventions
PROCEDURERegenerative Endodontic Treatment
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.
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primer success | 6 months and 12 months | Primer success is evaluated based on the absence of clinical symptoms and radiographic healing of the periapical lesion. |
| Secondary success | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | baseline, day 1, day 2, and day 7 after treatment | Postoperative pain was evaluated using a visual analogue scale. |
| Periapical Lesion Area | Baseline, 6 months, 12 months | Changes in the periapical lesion area were measured using digital radiographic analysis. |
| Mean Gray Value | Baseline, 6 months, 12 months | Bone density changes in the periapical region were evaluated using mean gray value measurements obtained from digital radiographs. |
| Fractal Dimension | Baseline, 6 months, 12 months | Changes in trabecular bone microarchitecture in the periapical region were evaluated using fractal dimension analysis. |
Countries
Turkey (Türkiye)
Outcome results
None listed