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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:
Researchers compared two treatment approaches that use different apical preparation sizes to see if one leads to better clinical and radiographic healing.
Participants:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAF 40 group | Experimental | Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 40. |
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| MAF 80 group | Experimental | Participants receive regenerative endodontic treatment with apical preparation completed to ISO size 80. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primer success | Primer success is evaluated based on the absence of clinical symptoms and radiographic healing of the periapical lesion. | 6 months and 12 months |
| Secondary success | Secondary success was defined as the recovery of pulp sensibility, evaluated using cold and electric pulp tests during follow-up examinations. | 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Postoperative pain was evaluated using a visual analogue scale. | baseline, day 1, day 2, and day 7 after treatment |
| Periapical Lesion Area | Changes in the periapical lesion area were measured using digital radiographic analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University Faculty of Dentistry, Department of Endodontics | Istanbul | Istanbul | 34854 | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2026 | Mar 7, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 7, 2026 | Mar 7, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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|
| Baseline, 6 months, 12 months |
| Mean Gray Value | Bone density changes in the periapical region were evaluated using mean gray value measurements obtained from digital radiographs. | Baseline, 6 months, 12 months |
| Fractal Dimension | Changes in trabecular bone microarchitecture in the periapical region were evaluated using fractal dimension analysis. | Baseline, 6 months, 12 months |
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |