- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07768852
Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis
Outcome, Quality of Life and Patient Satisfaction After Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis: A Prospective Exploratory Clinical Study.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a single-arm, prospective clinical study evaluating the effectiveness of full pulpotomy in mature permanent posterior teeth diagnosed with symptomatic or asymptomatic irreversible pulpitis and associated periapical radiolucency. The study will be conducted at the endodontic postgraduate, with a minimum target of 30 teeth in 30 patients recruited consecutively during the study period.
Eligible teeth will undergo clinical and radiographic assessment, including cold sensibility testing, percussion, palpation, periodontal assessment, and periapical radiography. Following local anesthesia and rubber dam isolation, caries will be completely removed and full pulpotomy will be performed to the level of the root canal orifices. The vitality of the remaining pulp tissue will be assessed clinically. Hemostasis will initially be attempted using sodium hypochlorite-moistened cotton pellets. A 980-nm diode laser will then be applied to the pulp tissue to assist hemostasis. Following adequate hemostasis, a calcium silicate-based pulp capping material will be placed over the pulp stumps, followed by a resin-modified glass ionomer liner and definitive resin composite restoration.
Teeth found to have complete pulpal necrosis or in which adequate hemostasis cannot be achieved will not proceed with the pulpotomy protocol and will receive appropriate endodontic treatment according to the clinical findings.
Clinical and radiographic follow-up will be performed at 6 and 12 months, with additional follow-up planned at 24 and 36 months. Periapical radiographs will be obtained during follow-up, and limited-field CBCT will be obtained immediately after treatment and at 12 months to assess changes in the periapical lesion. Treatment success will be determined based on the absence of clinical signs and symptoms and evidence of resolution or reduction of the periapical lesion. Radiographic healing will be assessed by comparing follow-up images with baseline postoperative images.
Patient-reported outcomes will include postoperative pain, analgesic intake, oral health-related quality of life, and patient satisfaction. Pain will be assessed before treatment and at 3 days and 1 week after treatment. Oral health-related quality of life and patient satisfaction will be assessed before treatment, at 1 week, and at 12 months.
The study will provide clinical and radiographic evidence regarding the feasibility and outcome of full pulpotomy in selected permanent teeth with irreversible pulpitis and periapical radiolucency. It will also assess patient-reported outcomes associated with this treatment approach and explore whether full pulpotomy may represent a less invasive alternative to conventional root canal treatment in appropriately selected cases.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nessrin Taha, DclinDent (Endo), PhD
- Numéro de téléphone: +962776566110
- E-mail: n.taha@just.edu.jo
Sauvegarde des contacts de l'étude
- Nom: Nessrin Taha, PhD
- Numéro de téléphone: +962777258907
- E-mail: nessrin_taha@yahoo.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
• Non -contributory medical history (SAI, II).
- Posterior permanent tooth (premolar, molar).
- Age range 8-30 years
- Deep caries extending into the inner quarter of dentin or exposing the pulp on the periapical radiograph
- The tooth should give positive response to cold sensibility testing
- Clinical diagnosis of symptomatic/asymptomatic irreversible pulpitis based on the symptoms, radiographic findings and results of cold testing
- The tooth is restorable, probing pocket depth and mobility are within normal limits
- Periapical radiograph demonstrates the presence of periapical lesion.
Exclusion Criteria:
- Non-restorable tooth.
- Signs of pulpal necrosis including sinus tract or swelling.
- Evidence of necrotic tissue in one or all canals.
- Profuse pulpal bleeding and inability to achieve hemostasis.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis.
Participants will receive full pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis.
Treatment outcomes will be evaluated clinically and radiographically during follow-up.
|
Full pulpotomy will be performed in permanent teeth with irreversible pulpitis and apical periodontitis, with diode laser-assisted hemostasis and calcium silicate-based pulp capping.
The intervention is distinguished by the treatment of teeth with radiographic evidence of apical periodontitis using a full pulpotomy approach rather than conventional root canal treatment.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Success of pulpotomy
Délai: 6 and 12 months
|
Treatment success will be determined by the absence of clinical signs and symptoms of disease, together with radiographic evidence of healing or reduction of the periapical lesion.
|
6 and 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative pain
Délai: 3 and 7 days after treatment
|
Postoperative pain will be assessed using a numerical rating scale from 0 to 10, where 0 represents no pain and 10 represents the most severe pain.
|
3 and 7 days after treatment
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oral health-related quality of life
Délai: Before treatment, 1 week and 12 months after treatment
|
Oral health-related quality of life will be assessed using the Oral Health Impact Profile questionnaire modified for endodontic treatment.
|
Before treatment, 1 week and 12 months after treatment
|
|
Tooth Survival
Délai: 12, 24, and 36 months
|
Tooth survival will be assessed based on percentage of the treated teeth remains present and functional during the follow-up period.
|
12, 24, and 36 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Nessrin Taha, DClinDent, PhD, Jordan University of Science and Technology
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 550/226
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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