Effect of Age on the Success of DPC Using Bio-ceramic Materials in Cariously Exposed Teeth With Reversible Pulpitis

NCT ID: NCT06240169

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-03-30

Brief Summary

Study Title: - Effect of age on the success of direct pulp capping using bio-ceramic materials in cariously exposed teeth with reversible pulpitis: A Prospective clinical study.

Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion with reversible pulpitis, vital pulp therapy procedures in the form of direct pulp capping(DPC)is more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Patient's age may have a role in the survival rate after direct pulp capping and the role of the pulp capping material has been recognized as an important parameter for the success of treatment.

Research Question : Does age has any influence on the success of DPC procedure and is there any difference between MTA and Biodentine as DPC material in cariously exposed permanent teeth with reversible pulpitis? Aim & Objectives- To evaluate the effect of age on success of Direct Pulp Capping, to evaluate the success of MTA and Biodentine as direct pulp capping agents.

Detailed Description

Study Title: - Effect of age on the success of direct pulp capping using bio-ceramic materials in cariously exposed teeth with reversible pulpitis: A Prospective clinical study.

Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion with reversible pulpitis, vital pulp therapy procedures in the form of direct pulp capping(DPC)is more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Patient's age may have a role in the survival rate after direct pulp capping and the role of the pulp capping material has been recognized as an important parameter for the success of treatment.

Research Question : Does age has any influence on the success of DPC procedure and is there any difference between MTA and Biodentine as DPC material in cariously exposed permanent teeth with reversible pulpitis? Aim & Objectives- To evaluate the effect of age on success of Direct Pulp Capping, to evaluate the success of MTA and Biodentine as direct pulp capping agents based on clinical and radiographic findings and assessment of post operative pain for 7 days post treatment.

Statistical method: - Data analysis by suitable statistical method.

Conditions

Pulpitis Reversible

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DPC in AGE I with MTA

DPC using MTA in Age group I i.e. 18-40years.

Group Type: EXPERIMENTAL

DPC with MTA in AGEI

Intervention Type: PROCEDURE

DPC using MTA in 18-40 years

DPC in AGE I with BD

DPC using BD in Age group I i.e. 18-40years.

Group Type: EXPERIMENTAL

DPC with BD in AGEI

Intervention Type: PROCEDURE

DPC using BD in 18-40 years

DPC in AGE II with MTA

DPC using MTA in Age group II i.e. 41-60years

Group Type: EXPERIMENTAL

DPC with MTA in AGEII

Intervention Type: PROCEDURE

DPC using MTA in 41-60Years

DPC in AGE II with BD

DPC using BD in Age group II i.e. 41-60years

Group Type: EXPERIMENTAL

DPC with BD in AGEII

Intervention Type: PROCEDURE

DPC using BD in 41-60Years

Interventions

DPC with MTA in AGEI

DPC using MTA in 18-40 years

Intervention Type: PROCEDURE

DPC with BD in AGEI

DPC using BD in 18-40 years

Intervention Type: PROCEDURE

DPC with MTA in AGEII

DPC using MTA in 41-60Years

Intervention Type: PROCEDURE

DPC with BD in AGEII

DPC using BD in 41-60Years

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Healthy patients (ASA I and ASA II).
• Patients falling in the age group of 18-60 years.
• Restorable permanent mandibular posterior teeth.
• Extremely deep caries penetrating the entire thickness of dentine and exhibiting signs and symptoms of reversible pulpitis.
• Teeth responding positively to cold test and electric pulp testing with no tenderness on percussion.

Exclusion Criteria

• Primary teeth.
• Traumatic or mechanical exposure.
• No pulp exposure after caries excavation.
• Hemostasis not achieved within 10 mins.
• Teeth with irreversible pulpitis.
• Presence of periapical lesion or evidence of internal or external resorption, calcified canals, as assessed by radiographic examination.
• Patients with periodontal disease, swelling and sinus tract.
• Immunocompromised or pregnant patients, patients with any systemic disease, and a positive history of antibiotic use within 1 month and analgesic use within week before the treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay Tewari

Role: PRINCIPAL_INVESTIGATOR

pgids rohtak

Locations

PGIDS

Rohtak, Haryana, India

Countries

India

Other Identifiers

Harshita Wadhwa

Identifier Type: -

Identifier Source: org_study_id