Clinical trial NCT01468480: Human Pulpal Response After Pulp Capping With Four Different Agents
Official title: Comparison of Human Pulpal Response After Pulpal Exposure to Common Treatments and Single-visit MTA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dental Pulp Exposure
Keywords: direct pulp capping
MTA
Single visit pulp cap
Multical
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: histologic findings - inflammation of the pulp
timeFrame: 6weeks
Secondary outcomes:
measure: histologic findings - formation of the dentinal bridge
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mahta Fazlyab
Study officials:
affiliation: Fazlyab Mahta
name: Mahta Fazlyab, Resident
role: PRINCIPAL_INVESTIGATOR
References: