Chronic Apical Periodontitis
Conditions
Brief 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. 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.
Interventions
PROCEDURESingle-Visit Regenerative Endodontic Treatment
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.
PROCEDUREMultiple-Visit Regenerative Endodontic Treatment
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.
Sponsors
Marmara University
Marmara University Scientific Research Projects Unit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secondary success | 12 months | Positive response to electric pulp testing is assessed. |
| Primer success | 12 months | Primary success is defined as the absence of clinical symptoms and evidence of periapical healing on radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 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. |
| Periapical Lesion Area | Baseline and 12 months | Changes in periapical lesion area are assessed using digital radiographic analysis. |
| Mean Gray Value | Baseline and 12 months | Changes in bone density in the periapical region are assessed using mean gray value measurements obtained from digital radiographs. |
| Fractal Dimension | Baseline and 12 months | Changes in trabecular bone microarchitecture in the periapical region are assessed using fractal dimension analysis. |
Countries
Turkey (Türkiye)
Outcome results
None listed