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

NCT06240169 | Unknown

• 1 other identifier: Harshita Wadhwa
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis Reversible

Outcome Measures

Primary Outcomes (1)

• clinical and radiographic success rates and evaluation of the effect of age on the success of procedure.

  CLINICAL SUCCESS CRITERIA * Absence of sign and symptoms of pain on stimulus or spontaneous pain. * Absence of tenderness to palpation or percussion and presence of functional tooth. * Absence of any soft tissue swelling sinus or fistula. * Normal tooth mobility and no periodontal probing depth. * Positive response to pulp sensibility test (cold and EPT). RADIOGRAPHIC SUCCESS CRITERIA * Periapical Index (PAI) score ≤2. * Absence of external or internal root resorption. Also, to evaluate the effect of age on the success of procedure.

  Baseline to 18 months

Secondary Outcomes (1)

• Post operative pain Secondary outcome measure will be pain intensity after treatment. Secondary outcome measure will be pain intensity after treatment. Secondary outcome measure will be pain intensity after treatment.

  Base line to 7 days

Study Arms (4)

DPC in AGE I with MTA

EXPERIMENTAL

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

Procedure: DPC with MTA in AGEI

DPC in AGE I with BD

EXPERIMENTAL

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

Procedure: DPC with BD in AGEI

DPC in AGE II with MTA

EXPERIMENTAL

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

Procedure: DPC with MTA in AGEII

DPC in AGE II with BD

EXPERIMENTAL

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

Procedure: DPC with BD in AGEII

Interventions

DPC with MTA in AGEI PROCEDURE

DPC using MTA in 18-40 years

DPC in AGE I with MTA

DPC with BD in AGEI PROCEDURE

DPC using BD in 18-40 years

DPC in AGE I with BD

DPC with MTA in AGEII PROCEDURE

DPC using MTA in 41-60Years

DPC in AGE II with MTA

DPC with BD in AGEII PROCEDURE

DPC using BD in 41-60Years

DPC in AGE II with BD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Sanjay Tewari

  pgids rohtak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients and the outcome assessors will be blinded to the allocation groups (double-blinding). But the operator (Principal investigator) will not be blinded due to the nature of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 2, 2024
• Study Start: June 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)