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Assessing full pulpotomy in permanent teeth with irreversible pulpitis using three calcium silicate cements

Evaluation of vital full pulpotomy techniques in permanent mature teeth with symptomatic irreversible pulpitis using three calcium silicate cements

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16268487
Enrollment
40
Registered
2025-03-17
Start date
2021-02-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible pulpotomy treatment Oral Health

Interventions

Patients were assured that their medical care would not be affected should they choose not to participate. Documentation explicitly noted that the treated premolars would be extracted after the agreed

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 20 Years

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

MeasureTime 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

MeasureTime 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

Public ContactYasser;Sarah Alsayed Tolibah;Nassri

;

yasseralsayedtolibah@gmail.com;Sarahnassri@gmail.com+963 (0)988812044;+963 (0)933092075

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026