Partial Pulpotomy on Caries Free Human Teeth

Pulpitis Clinical Trial

Official title:

Partial Pulpotomy on Caries Free Human Teeth Using iRootBP and White ProRoot MTA: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420718
• Other study ID #: p/439/d
• Secondary ID: IRCT201102145804
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 19, 2011
• Last updated: March 25, 2012
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 14 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dentin Bridge
• Pulpitis

Intervention

Drug:
• MTA
partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.
• iRoot BP
Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).

Locations

Country	Name	City	State
Iran, Islamic Republic of	Azad University, Dental Branch, Tehran, Endodontic department	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	dentinal bridge formation	appearance of the dentinal bridge compared to normal dentin will be assessed under microscope	six weeks after intervention	No
Secondary	inflammatory status of the pulp	microscopic evaluation : inflammatory cell count and their distribution	six weeks after intervention	No