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Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .

26 juillet 2026 mis à jour par: Postgraduate Institute of Dental Sciences Rohtak

Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study

The aim of the study is to compare the clinical and radiographic outcomes of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Primary objective of the study is to evaluate the clinical and radiographic success of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Secondary objective of the study is to evaluate and compare postoperative pain following direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. Subjects of age group 18 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with deep carious lesion 2) Permanent mature molars with extremely deep carious lesion.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

TITLE-Comparative evaluation of direct pulp capping between deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis. PICO P (Population) -Mature permanent mandibular molars with clinical signs of reversible pulpitis. I (Intervention) - Direct pulp capping in teeth with extremely deep carious lesion. C (Comparison) - Direct pulp capping in teeth with deep carious lesion. O (Outcome) - 1. Assessment of clinical success at 7 days, 6 months, 12 months and radiographic success at 6 and 12 months of follow up. To assess pain experience at preoperative and post operatively at 24 hours intervals for one week. Direct pulp capping is considered as the most conservative procedure to treat mechanically or traumatically exposed pulp. In this procedure, biomaterial is directly applied on the exposed pulp. According to depth of caries, carious lesion has been classified as deep caries (reaching inner quarter of dentine) and extremely deep caries (extending through entire dentine thickness). Various studies on direct pulp capping in deep carious lesions with reversible pulpitis have reported success rates ranging from 77.3% to 100%. A prospective study by demonstrated a 95.2% success rate for direct pulp capping with extremely deep carious lesions and reversible pulpitis in young individuals. A randomized clinical trial , which included both deep and extremely deep carious lesions, reported a direct pulp capping success rate of 81.3%. A recent systematic review and meta-analysis highlighted that the depth of caries penetration is a critical factor that need to be considered when evaluating the outcomes of direct pulp capping in cariously exposed pulps. Currently, there is a lack of clinical trials comparing the effectiveness of direct pulp capping in cases of deep and extremely deep caries presenting with reversible pulpitis. Hence, the present trial is designed to assess differences in clinical and radiographic outcomes of direct pulp capping between deep and extremely deep carious lesions in mature permanent teeth diagnosed with reversible pulpitis.

Type d'étude

Interventionnel

Inscription (Estimé)

130

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Inde
    • Haryana
      • Rohtak, Haryana, Inde, 124001
        • Recrutement
        • PGIDS , Rohtak
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. The patient should be 18-40 years of age.
  2. Patients with deep and extremely deep caries in permanent mandibular molars.
  3. Deep caries lesion -Reaching the inner quarter of dentine on radiograph
  4. Extremely deep caries lesion - Caries penetrating the entire thickness of dentin on radiograph.
  5. Reversible pulpitis will be diagnosed clinically based on discomfort experienced by the participant when a stimulus such as cold or sweet is applied and goes away within a couple of seconds following removal of stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and pain experienced is not spontaneous.
  6. Tooth should give positive response to pulp sensibility testing.
  7. Bleeding can be controlled with in 8 minutes.
  8. Radiographic finding of periapical index (PAI) score ≤2.
  9. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).

Exclusion criteria

  1. Teeth with immature roots.
  2. Internal/external resorption.
  3. Patient experience spontaneous pain.
  4. Negative response to vitality testing
  5. No pulp exposure after complete caries excavation.
  6. Signs of pulpal necrosis, insufficient bleeding after pulp exposure, sinus tract, swelling.
  7. Bleeding could not be controlled in 8 minutes.
  8. Pregnant women
  9. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency diseases , infectious diseases, kidney or liver, migraine)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Direct pulp capping in deep carious lesion
Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds.
Procédure: Direct pulp capping in deep carious lesion.
After pulp exposure, pulp wound will be irrigated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes. Hemostasis will be achieved with 3% NaOCl . The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured. After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer of RMGIC. Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.
Expérimental: Direct pulp capping in extremely deep carious lesion
Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis . If the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds.
Procédure: Direct pulp capping in extremely deep carious lesion.
After pulp exposure, pulp wound will be irrigated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes till. Hemostasis will be achieved with 3% NaOCl .The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured. After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer of RMGIC. Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Success rate at 12 months
Délai: 12 months
Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Absence of associated soft tissue swelling, sinus or fistula. Radiographic: - 1. Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (Periapical index score 1 or 2 ). 3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Postoperative pain
Délai: Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
Post Operative Pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain.
Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Postgraduate Institute of Dental Sciences Rohtak

Les enquêteurs

  • Chercheur principal: Dr. Vinay Kumar, MDS, PGIDS, Rohtak

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 avril 2026

Achèvement primaire (Estimé)

28 octobre 2027

Achèvement de l'étude (Estimé)

28 avril 2028

Dates d'inscription aux études

Première soumission

6 juillet 2026

Première soumission répondant aux critères de contrôle qualité

6 juillet 2026

Première publication (Réel)

10 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • Vineeta

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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