Clinical trial NCT01420718: Partial Pulpotomy on Caries Free Human Teeth
Official title: Partial Pulpotomy on Caries Free Human Teeth Using iRootBP and White ProRoot MTA: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dentin Bridge
Pulpitis
Keywords: partial pulpotomy
Cvek pulpotomy
MTA
iRootBP
dentin bridge
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the human pulp response to partial pulpotomy using White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.

Detailed description: This will be a randomized single blind clinical trial. Setting and conduct: Twenty caries free premolar teeth from fifteen patients assigned for orthodontic extraction will be included. Participants including major eligibility criteria: Their parents need to sign an informed form, Patients shouldn't have any systematic complication, The teeth should be free of any symptom, caries and decalcification and should reveal a normal response to pulp sensitivity tests, No mobility or swelling in the surrounding soft tissues, sensitivity on palpation or percussion should be present. Intervention: A class one cavity will be prepared and the depth will be increased until the pulp exposure occurs. One millimeter of the coronal pulp will be removed. Then the exposure site will be covered using two pulpotomy agents: White ProRoot MTA as control group and iRoot BP. After six weeks (42 days) the teeth will be extracted after radiographic and clinical examination to find any sign of swelling, abscess or sinus tract. Main outcome measures (variables): The teeth will be sectioned and examined to compare the presence of dentinal bridge, its thickness and feature in the terms of tunnel defect formation. The underlying pulp will be assessed and graded according to the degree of inflammation as follows: grade 0 no inflammation, grade 1 mild inflammation, grade 2 moderate inflammations, grade 3 severe inflammation, grade 4 abscess formation or necrosis. Our criteria are based on ISO 7405.

Eligibility criteria: Inclusion Criteria:

* Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan.
* Their parents need to read and sign a fully informed form.
* They shouldn't have any systematic complication or take any medicine during the period of study.
* The teeth need to be free of any symptom, caries and decalcification
* They should give a normal response to pulp sensitivity tests (cold test) compared to the control tooth on the same quadrant.
* The teeth need to be free of mobility or swelling in the surrounding soft tissues and any sensitivity on palpation or percussion.
* On radiographic examination no apical lucency or PDL widening should be detected.

Exclusion Criteria:

* tooth crack
* tooth filling
* any caries
* hypocalcification
* The teeth showing apical lucency
* PDL widening on radiography
* sensitivity to cold, heat or bite
* The responses beyond the normal limits to pulp vitality testing
* Any medicine consumption

Primary outcomes:
measure: dentinal bridge formation
timeFrame: six weeks after intervention
Secondary outcomes:
measure: inflammatory status of the pulp
timeFrame: six weeks after intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Azad University, Dental Branch, Tehran, Endodontic department
Study officials:
affiliation: Azad University, Dental Branch, Tehran
name: Mahta Fazlyab
role: PRINCIPAL_INVESTIGATOR
References: