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Completed

NCT Number: NCT03522051

Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure

Many deep carious teeth are treated unnecessarily by root canal therapy, while with using current techniques and advances in compatible dental materials in addition to better understanding of biological response of the dental pulp, many can be treated conservatively via vital pulp therapy procedures.

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Key information

Conditions

Pulpotomy Dental Pulp Diseases Pulpitis Stomatognathic Diseases Tooth Diseases

Age range

7 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of science and technology

Irbid, 22110, Jordan

About this study

Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially inflamed pulps in which the remaining healthy tissue can be conserved and protected by a biologically active material to generate a hard tissue barrier that seals and protects the pulp from future microbial insult.

The aim of this in vivo study is to clinically and radiographically assess the outcome of full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with carious exposure.

Ethics approval was obtained from the institutional ethics and research committee, and the patients were informed about details of the treatment and the possible complications. An informed consent was obtained. 120 patients meeting the inclusion criteria will be selected for this study and they will be subsequently followed up clinically and radiographically after 3 months, 6 months, 1 year and yearly afterward for 5 years.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Permanent teeth with mature or immature apices
  • Have no significant medical problems
  • The tooth should give positive response to cold test and electric pulp test (EPT)
  • Probing pocket depth and mobility within normal limits
  • No Signs of pulp necrosis including sinus tract or swelling
  • Radiographically ; caries either exposing the pulps or reaching more than 2\\3 the distance from the dentino-enamel junction (DEJ) to the pulp
  • The tooth can be restored via direct restoration

Exclusion criteria

  • Medically compromised patients
  • Negative response to cold test
  • Mobility
  • Sinus tract
  • Swelling
  • Non restorable teeth or badly broken teeth

Treatment and study plan

calcium silicate based material,

Other

Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation

Other names: Neo MTA plus, Avalon Biomed

Primary outcomes

  1. Change in pain symptoms

    Time frame: 2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years.

    The patient is anticipated to report reduction in the pain score after receiving the treatment within 2-3 days and the tooth should continue to be asymptomatic at follow up appointments. The patient will be asked to score the pain level on visual analogue scale using a score from 0-10. The zero is no pain while 10 is the maximum level.

Secondary outcomes

  1. Periapical normalcy at follow up radiographs .

    Time frame: 6months , 1 year, 2, 3,4,5 years

    Pr-existing pathology should heal within 6 months- 1 year and normalcy should be maintained after ward up to 5 years.

    no emerging pathosis should be evident in the roots or surrounding bone.

  2. The tooth and restoration should be present in the mouth

    Time frame: 3, 6 months, 1 year, 2, 3,4,5 years

    The tooth should be in the mouth and in function (not extracted) with an intact restoration at the follow up times

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Acronym: PULPOTOMY

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
May 11, 2018
Registry last updated
Sep 16, 2021

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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