Clinical trial NCT06240169: Effect of Age on the Success of DPC Using Bio-ceramic Materials in Cariously Exposed Teeth With Reversible Pulpitis
Official 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulpitis Reversible
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: clinical and radiographic success rates and evaluation of the effect of age on the success of procedure.
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: 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.
timeFrame: Base line to 7 days
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: pgids rohtak
name: Sanjay Tewari
role: PRINCIPAL_INVESTIGATOR
References: