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Human Pulpal Response After Pulp Capping With Four Different Agents

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01468480
Enrollment
32
Registered
2011-11-09
Start date
2010-06-30
Completion date
2011-03-31
Last updated
2011-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pulp Exposure

Keywords

direct pulp capping, MTA, Single visit pulp cap, Multical

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.

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.

Interventions

DRUGPro Root MTA

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

DRUGPro Root MTA- single visit

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

DRUGMultiCal

application of Multical in forth group as a pulp dressing agent

DRUGDycal

application of Dycal in first group as a pulp dressing agent

Sponsors

Islamic Azad University, Sanandaj
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
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.

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.

Design outcomes

Primary

MeasureTime frameDescription
histologic findings - inflammation of the pulp6weeksAccording 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

MeasureTime frameDescription
histologic findings - formation of the dentinal bridge6 weeksThe specimens will be evaluated in the terms of dentinal bridge formation and its resemblence to natural dentin and also the thickness of the bridge.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026