Human Pulpal Response After Pulp Capping With Four Different Agents

Islamic Azad University, Tehran

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dental Pulp Exposure

Treatments: Drug: Pro Root MTA; Drug: Pro Root MTA- single visit; Drug: Dycal; Drug: MultiCal

Study type: Interventional

Funder types: Other

Identifiers

NCT01468480

p/261/d

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 4 patient groups

Pro Root MTA- standard method

Experimental group

Description:

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

Treatment:

Drug: Pro Root MTA

Pro Root MTA- single visit

Experimental group

Description:

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

Treatment:

Drug: Pro Root MTA- single visit

MultiCal / LimeLite

Experimental group

Description:

application of Multical in forth group

Treatment:

Drug: MultiCal

Dycal

Active Comparator group

Description:

application of Dycal in first group as a pulp dressing agent

Treatment:

Drug: Dycal