Direct Pulp Capping With MTA and Calcium Hydroxide.

NCT03284697 | Completed DMC

• 1 other identifier: Komal Suhag
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim of the study was to evaluate and compare clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials in cariously exposed mandibular molars. Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry \& Endodontics. Mature permanent mandibular molars with reversible pulpitis exhibiting occlusal pulp exposure from primary dental caries were included in the study. After excavation of caries and obtaining pulpal hemostasis, patients were randomly allocated into two groups- MTA and Calcium Hydroxide. Pulp was capped with respective allocated material and then tooth in both groups were restored according to standard protocol.

Conditions

Reversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.

  CRITERIA FOR SUCCESSFUL OUTCOME * A positive vitality test. * No pain on percussion. * No widening of periodontal ligament on periapical radiograph. * No clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis. CRITERIA FOR FAILURE * No response to pulp vitality test. * Teeth exhibiting clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.

  Baseline to 1 year

Secondary Outcomes (1)

• To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).

  Baseline to 7 days

Study Arms (2)

DPC with Ca(OH)2

ACTIVE COMPARATOR

Direct pulp capping with Ca(OH)2.

Procedure: Direct Pulp Capping with Ca(OH)2

DPC with MTA

ACTIVE COMPARATOR

Direct pulp capping with MTA

Procedure: Direct Pulp Capping With MTA

Interventions

Direct Pulp Capping with Ca(OH)2 PROCEDURE

Calcium hydroxide powder was mixed with saline and placed over the exposed pulp tissue. The cavities were then restored with resin modified GIC liner followed by composite restoration.

Also known as: Vital Pulp Therapy

DPC with Ca(OH)2

Direct Pulp Capping With MTA PROCEDURE

MTA was mixed using1:3 water/ powder ratio and applied to exposure site. Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed provisionally with IRM. After 24 hours, the patient was recalled and the cavity was restored with resin modified GIC liner followed by composite restoration.

Also known as: Vital pulp therapy

DPC with MTA

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient willing to participate in the study.
• Age group- 15-40 years.
• Mature permanent mandibular molars with reversible pulpitis.
• Teeth exhibiting occlusal pulp exposure from primary dental caries.

You may not qualify if:

• Primary teeth.
• Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract, and furcation or apical radiolucency.
• Immuno-compromised, diabetic, pregnant and hypertensive patients.
• Positive history of antibiotic and analgesic use within past one month of the treatment.
• Failure to obtain authorization from patients.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 15, 2017
• Study Start: October 14, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share