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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulpitis Reversible
• Intervention / Treatment: Procedure: DPC with MTA in AGEI; Procedure: DPC with BD in AGEI; Procedure: DPC with MTA in AGEII; Procedure: DPC with BD in AGEII

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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • PGIDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DPC in AGE I with MTA; DPC using MTA in Age group I i.e. 18-40years.	Procedure: DPC with MTA in AGEI; DPC using MTA in 18-40 years
Experimental: DPC in AGE I with BD; DPC using BD in Age group I i.e. 18-40years.	Procedure: DPC with BD in AGEI; DPC using BD in 18-40 years
Experimental: DPC in AGE II with MTA; DPC using MTA in Age group II i.e. 41-60years	Procedure: DPC with MTA in AGEII; DPC using MTA in 41-60Years
Experimental: DPC in AGE II with BD; DPC using BD in Age group II i.e. 41-60years	Procedure: DPC with BD in AGEII; DPC using BD in 41-60Years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 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	Base line to 7 days

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Sanjay Tewari, Pgids Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: Harshita Wadhwa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No