Human Pulpal Response After Pulp Capping With Four Different Agents

Sponsor

Islamic Azad University, Tehran (Other)

Overall Status

Completed

CT.gov ID

NCT01468480

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dental Pulp Exposure	Drug: Pro Root MTA Drug: Pro Root MTA- single visit Drug: MultiCal Drug: Dycal	Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pro Root MTA- standard method application of MTA in second group and 24 hour interval before restoration	Drug: Pro Root MTA application of MTA in second group and 24 hour interval before restoration Other Names: Mineral Trioxide Aggregate
Experimental: Pro Root MTA- single visit Intervention/Control application of MTA in third group and 15 minute interval before restoration	Drug: Pro Root MTA- single visit application of MTA in third group and 15 minute interval before restoration Other Names: Mineral Trioxide Aggregate
Experimental: MultiCal / LimeLite application of Multical in forth group	Drug: MultiCal application of Multical in forth group as a pulp dressing agent Other Names: Hard set calcium hydroxide paste
Active Comparator: Dycal application of Dycal in first group as a pulp dressing agent	Drug: Dycal application of Dycal in first group as a pulp dressing agent Other Names: chemical set calcium hydroxide

Outcome Measures

Primary Outcome Measures

histologic findings - inflammation of the pulp [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 Outcome Measures

histologic findings - formation of the dentinal bridge [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.