Partial Pulpotomy on Caries Free Human Teeth

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

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.

Study Overview

• Status: Completed
• Conditions: Pulpitis; Dentin Bridge
• Intervention / Treatment: Drug: MTA; Drug: iRoot BP

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1946853314
    • Azad University, Dental Branch, Tehran, Endodontic department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Mineral Trioxide Aggregate; partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.	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.; Other Names: White ProRoot MTA
EXPERIMENTAL: 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).	Drug: 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).; Other Names: Injectable Root Bioaggregate Paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dentinal bridge formation	appearance of the dentinal bridge compared to normal dentin will be assessed under microscope	six weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory status of the pulp	microscopic evaluation : inflammatory cell count and their distribution	six weeks after intervention

Collaborators and Investigators

• Sponsor: Islamic Azad University, Tehran
• Investigators: Principal Investigator: Mahta Fazlyab, Azad University, Dental Branch, Tehran

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: August 19, 2011
• First Submitted That Met QC Criteria: August 19, 2011
• First Posted (ESTIMATE): August 22, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2012
• Last Update Submitted That Met QC Criteria: March 25, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: MTA; dentin bridge; partial pulpotomy; Cvek pulpotomy; iRootBP
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: p/439/d; IRCT201102145804N2 (OTHER: Iranian registry of clinical trails (IRCT))