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Completed

NCT Number: NCT01468480

Human Pulpal Response After Pulp Capping With Four Different Agents

Application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity.

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Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mahta Fazlyab

Tehran, Tehran Province, 1946853314, Iran

About this study

The purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation & dentinal bridge formation. Methods: Eight patients providing 32 sound first premolars are selected. As recommended by ISO / TC 7405 pulpal exposure will be performed through a class I cavity. Four groups of eight specimens each will be defined according to the pulp capping method. Group A, will receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aging from 10 to 16
  • Patients who need to extract 4 premolars for orthodontic purposes
  • the teeth should be free of caries and clinical symptoms
  • Through thermal tests and radiographic examination absence of any pathology is confirmed.
  • Periapical radiographs demonstrating absence of any pathology
  • no sensitivity to percussion, palpation and biting, no sensitivity to cold after 5 seconds contact with Green Endo Ice refrigerant spray, heat sensitivity after applying tempered Gutta Percha for 10 seconds.
  • Absence of any systematic disorder
  • No consumption of drugs of any kind
  • All patients and their parents need to sign a fully informed consent.

Exclusion criteria

  • If any of the teeth shows caries, restoration, crack or hypocalcification
  • presence of any periapical pathosis
  • Teeth that seem sensitive to cold, hot, percussion or pressure
  • any systematic disorder
  • consumption of drugs of any kind.

Treatment and study plan

Pro Root MTA

Drug

application of MTA in second group and 24 hour interval before restoration

Other names: Mineral Trioxide Aggregate

Pro Root MTA- single visit

Drug

application of MTA in third group and 15 minute interval before restoration

Other names: Mineral Trioxide Aggregate

MultiCal

Drug

application of Multical in forth group as a pulp dressing agent

Other names: Hard set calcium hydroxide paste

Dycal

Drug

application of Dycal in first group as a pulp dressing agent

Other names: chemical set calcium hydroxide

Primary outcomes

  1. histologic findings - inflammation of the pulp

    Time frame: 6weeks

    According to histological evaluation and ISO/DIS7405, the investigators gave to non inflamed cases no points, mild cases 1 point, moderate cases 2 points, severe cases 3 points and necrosis 4 points.

Secondary outcomes

  1. histologic findings - formation of the dentinal bridge

    Time frame: 6 weeks

    The specimens will be evaluated in the terms of dentinal bridge formation and its resemblence to natural dentin and also the thickness of the bridge.

Sponsors and collaborators

Lead sponsor

Islamic Azad University, Sanandaj

Other

Registry information

Official study title

Comparison of Human Pulpal Response After Pulpal Exposure to Common Treatments and Single-visit MTA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2011
Registry last updated
Nov 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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