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Direct Pulp Capping With MTA and Calcium Hydroxide.

Primary Purpose

Reversible Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Direct Pulp Capping with Ca(OH)2
Direct Pulp Capping With MTA
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reversible Pulpitis

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    DPC with Ca(OH)2

    DPC with MTA

    Arm Description

    Direct pulp capping with Ca(OH)2.

    Direct pulp capping with MTA

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).
    Patients were instructed to score the pain experienced by them using VAS scale. Pain was recorded preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6, and 7 days following the procedure. Pain intensity was categorized as: no pain (0 - 4 mm), mild pain (5- 44), moderate pain (45-74 mm), and severe pain (75- 100 mm). Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity of pain experienced by them and note down the details of analgesic intake on the proforma regarding the number of doses required and timing of the dose.

    Full Information

    First Posted
    September 8, 2017
    Last Updated
    January 11, 2018
    Sponsor
    Postgraduate Institute of Dental Sciences Rohtak
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03284697
    Brief Title
    Direct Pulp Capping With MTA and Calcium Hydroxide.
    Official Title
    Success of Direct Pulp Capping With Mineral Trioxide Aggregate and Calcium Hydroxide In Cariously Exposed Teeth: A Randomized Clinical Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 14, 2016 (Actual)
    Primary Completion Date
    November 30, 2017 (Actual)
    Study Completion Date
    November 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Postgraduate Institute of Dental Sciences Rohtak

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    AIM AND OBJECTIVES The present study aims to Evaluate the success of direct pulp capping in mandibular molar teeth. Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials. To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS). MATERIALS AND METHODS Study subjects were recruited from the patients visiting the Department of conservative dentistry and endodontics, PGIDS, Rohtak. METHODOLOGY Prior to treatment, a thorough clinical and radiological examination was carried out. A thorough history will be taken from each patient. Prior informed consent was obtained either from the patient or guardians after explaining the procedure, risks and benefits. Clinical procedure: Mature mandibular permanent molars exhibiting deep caries approaching pulp were chosen for the study. The teeth were evaluated by periapical radiographs, periodontal probing, percussion test, and vitality assessment with thermal test and electric pulp test; the teeth determined to have reversible pulpitis were included. All periapical radiographs were exposed by using constant kVP, mA, and exposure time (70 KVP, 8 mA, and 0.8 sec.) with a Rinn paralleling device and processed manually. After administration of local anesthesia, rubber dam isolation of the involved tooth was done. The tooth was disinfected by scrubbing with 2% chlorhexidine and 75% isopropyl alcohol. Initially caries was removed with round bur under sterile water spray. Then, the remaining caries was removed carefully with a spoon excavator. After complete caries excavation, disinfection of exposed pulp with 2.5% sodium hypochlorite irrigation and a soaked cotton pellet was done. Then sodium hypochlorite dressing was placed for 10 minutes to achieve adequate pulpal hemostasis. Patients were randomly allocated into two groups (Group I - MTA and Group II -Calcium hydroxide) using a computer program This study was a double blinded trial i.e. both the patient and the investigator were not aware of the group to which the participant belongs. GROUP I- CALCIUM HYDROXIDE GROUP Calcium hydroxide powder was mixed according to manufacturer's instructions and applied directly onto the exposed pulps. The cavities were then restored with resin modified GIC liner followed by composite restoration. GROUP II - MTA GROUP MTA was mixed according to manufacturer's instructions i.e. 1:3 water/ powder ratio and applied to exposure site with a sterile carrier. Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed temporarily with intermediate restoration material. After 24 hours, the patient was recalled and the setting of MTA was confirmed and the cavity was restored with resin modified GIC liner followed by composite restoration. FOLLOW UP The patients were recalled periodically at 1 week, 3 months, 6 months and 12 months after the direct pulp capping procedure for clinical (post operative sensitivity, pain, tenderness, vitality) and radiographic (widening of periodontal ligament space and periapical radiolucency) evaluation. 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. Postoperative pain assessment: This was done using Horizontal VAS scale preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6, and 7 days after the procedure. The pain VAS was completed by the patients themselves. The patients were asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity of pain experienced by them and note down the details of analgesic intake on the proforma regarding the number of doses required and timing of the dose.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reversible Pulpitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DPC with Ca(OH)2
    Arm Type
    Active Comparator
    Arm Description
    Direct pulp capping with Ca(OH)2.
    Arm Title
    DPC with MTA
    Arm Type
    Active Comparator
    Arm Description
    Direct pulp capping with MTA
    Intervention Type
    Procedure
    Intervention Name(s)
    Direct Pulp Capping with Ca(OH)2
    Other Intervention Name(s)
    Vital Pulp Therapy
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Direct Pulp Capping With MTA
    Other Intervention Name(s)
    Vital pulp therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.
    Description
    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.
    Time Frame
    Baseline to 1 year
    Secondary Outcome Measure Information:
    Title
    To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).
    Description
    Patients were instructed to score the pain experienced by them using VAS scale. Pain was recorded preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6, and 7 days following the procedure. Pain intensity was categorized as: no pain (0 - 4 mm), mild pain (5- 44), moderate pain (45-74 mm), and severe pain (75- 100 mm). Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity of pain experienced by them and note down the details of analgesic intake on the proforma regarding the number of doses required and timing of the dose.
    Time Frame
    Baseline to 7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Direct Pulp Capping With MTA and Calcium Hydroxide.

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