Irreversible pulpotomy treatment Oral Health
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Radiographic Criteria: 1. Fully developed first or second permanent mandibular premolars with deep carious lesions 2. A relatively normal-sized pulp chamber without degenerative changes (e.g., pulp stones, diffuse calcifications, or significant chamber narrowing) 3. No periapical or furcal radiolucency 4. No internal or pathological external resorption 5. No signs of periodontal involvement, such as alveolar bone resorption Clinical Criteria: 1. Symptoms and clinical signs indicate symptomatic irreversible pulpitis, characterized by spontaneous, intermittent, sharp pain or prolonged pain after stimulus removal 2. The tooth is restorable without requiring a crown, post, or core-supported restoration 3. No periodontal disease; the gingival sulcus depth ranges from 1–3 mm from the free gingival margin to the epithelial attachment 4. No periodontal involvement, with tooth mobility within normal limits
Exclusion criteria
Exclusion criteria: 1. Patients with immune, bleeding disorders, systemic conditions affecting bleeding and clotting time, or those taking medications that alter metabolism 2. Immature premolars with open apices 3. Non-restorable teeth or those with periodontal disease 4. Severely narrowed pulp chambers or significant calcifications within the root canal system (e.g., pulp stones, diffuse calcifications) 5. Presence of periapical or furcal radiolucency 6. Internal or pathological external resorption 7. Signs of pulp necrosis, including negative responses to vitality tests, swelling, sinus tract, or positive percussion and palpation tests 8. Uncontrolled bleeding after pulpotomy for more than 10 minutes or abnormal pulp tissue appearance 9. Absence of bleeding or minimal dark red bleeding after pulp exposure or pulpotomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical evaluation: Patients of both groups will be recalled after 1, 3, 7, and 14 days of treatment and during radiographical assessment periods (3, 6 and 12 months), where they will be asked to rate their pain on the Wong-Baker Faces Scale, where children will set their pain levels by choosing a face; 0 = no hurt, 1 = hurts a little bit, 2 = hurts a little more 3 = hurts even more, 4 = hurts a whole lot, and 5 = hurts worst. Moreover, the presence of fistula, swelling, and movement will be recorded. 2. Radiographical assessment: after coronal restoration is completed a control x-ray will be taken. The periapical status will be assessed at the time of obturation-restoration, 3, 6, and 12 months following endodontic treatment. The outcome will be determined according to the Periapical Index scoring system: 1 = normal periapical structures; 2 = small changes in bone structure; 3 = changes in bone structure with some mineral loss; 4 = periodontitis with well-defined radiolucent area; 5 = severe periodontitis with exacerbating features. The teeth will be evaluated according to healed, healing or unsuccessful as a primary radiographical outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Histological evaluations at 1 week and 6 months: 1. Pulp inflammation was assessed based on inflammatory cell presence and graded as: 1 = No inflammation, 2= Mild inflammation (few inflammatory cells), 3 = Moderate inflammation, and 4 = Severe inflammation (dense inflammatory infiltrate). 2. Pulpal tissue disorganization was evaluated as: 1 = Normal pulp morphology, 2 = Slight superficial imbalance with a central intact pulp, 3 = Moderate imbalance extending beyond superficial layers, 4 = Severe imbalance with diffuse degeneration, and Complete pulp necrosis. 3. Dentinal bridge formation was assessed and classified as: 1 = No evidence of formation, 2= Initial formation, 3 = Incomplete or defective bridge, and 4 = Complete bridge without defects. | — |
Countries
Algeria, Syria
Contacts
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