Human Pulpal Response After Pulp Capping With Four Different Agents

Dental Pulp Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468480
• Other study ID #: p/261/d
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 4, 2011
• Last updated: November 8, 2011
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: November 2011
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Exposure

Intervention

Drug:
• Pro Root MTA
application of MTA in second group and 24 hour interval before restoration
• Pro Root MTA- single visit
application of MTA in third group and 15 minute interval before restoration
• MultiCal
application of Multical in forth group as a pulp dressing agent
• Dycal
application of Dycal in first group as a pulp dressing agent

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mahta Fazlyab	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histologic findings - inflammation of the pulp	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.	6weeks	Yes
Secondary	histologic findings - formation of the dentinal bridge	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.	6 weeks	Yes