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Completed

NCT Number: NCT01420718

Partial Pulpotomy on Caries Free Human Teeth

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.

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Key information

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Azad University, Dental Branch, Tehran, Endodontic department

Tehran, 1946853314, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MTA

Drug

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

iRoot BP

Drug

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

Primary outcomes

  1. dentinal bridge formation

    Time frame: six weeks after intervention

    appearance of the dentinal bridge compared to normal dentin will be assessed under microscope

Secondary outcomes

  1. inflammatory status of the pulp

    Time frame: six weeks after intervention

    microscopic evaluation : inflammatory cell count and their distribution

Sponsors and collaborators

Lead sponsor

Islamic Azad University, Sanandaj

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 22, 2011
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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