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Completed

NCT Number: NCT05266859

Efficacy of PRF and MTA as Compared to Calcium Hydroxide for Pulpotomy in Human Irreversibly Inflamed Permanent Teeth

Of all the various pulpotomy medicaments that have been studied till to date, three agents have been selected for this study to compare their efficacy. CH being the control, MTA being one of the most recommended biomaterial and PRF that in addition to being a biomaterial is an autologous agent. Uptil now there have been no prospective trials using these three pulpotomy agents in mature permanent teeth with irreversible pulpitis in our part of the world and even the international studies that have been done utilized different methodologies with no unanimous conclusion. This is the reason that at present this treatment regime (pulpotomy) showing better perspectives cannot be presented with confidence as a predictable treatment option to the patients with irreversible pulpitis. By virtue of this study this challenge is being undertaken.

Hypothesis:

ALTERNATE HYPOTHESIS There is a difference between the efficacy of the PRF, MTA and CH when used as pulpotomy medicaments in mature permanent teeth with irreversible pulpitis NULL HPOTHESIS There is no difference in efficacy of the PRF, MTA and CH when used as pulpotomy medicaments in mature permanent teeth with irreversible pulpitis

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Key information

Conditions

Pulpitis - Irreversible Dental Caries Stomatognathic Diseases Tooth Decay Tooth Demineralization Tooth Diseases

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liaquat College of Medicine and Dentistry

Karachi, Sindh, 75290, Pakistan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with permanent teeth with completely formed roots diagnosed with irreversible pulpitis i.e. showing signs and symptoms as spontaneous, lingering pain initiated by hot and cold stimulus and /or radiating. Pulp being exposed or near to exposure by caries or alternatively by trauma.

Exclusion criteria

  • CLINICALLY Teeth with
  • Necrotic pulp
  • History of swelling, abscess , fistula and/ or sinus tract
  • Doubtful restorability as indicated by over all Dental Practicality Index- (DPI) > 2 (Dawood and Patel 2017) will be excluded
  • Periodontal disease
  • Uncontrolled bleeding (more that 10 mins.) of pulp after removal of inflamed part.
  • No bleeding of pulp at all after access into pulp RADIOGRAPHICALLY (with the use of periapical radiographs) Teeth with
  • Internal/ external pathologic root resorption
  • Pulp canal obliteration
  • Periapical / furcal radiolucency
  • Resorbed roots.
  • Crestal bone loss Generally patients
  • With systemic diseases, bleeding disorders, physical or mental disability, pregnant or nursing.
  • On opioid or steroid therapy or anticoagulants and/or on any kind of antibiotics.
  • Who have gone through some previous treatment for the same tooth other than filling.

Treatment and study plan

Calcium hydroxide

Other

Calcium hydroxide in the power/liquid form will be used and placed on the exposed pulp

MTA

Other

Mineral trioxide aggregate will be used as a powder / liquid form and placed over the exposed pulp

PRF

Other

PRF will be placed directly over the exposed pulp

Primary outcomes

  1. Clinical Success or Failure

    Time frame: 12 months

    Incidence of pain, swelling, sinus tract formation, tenderness to percussion after specified time period after intervention

  2. Radiographic Success or Failure

    Time frame: 12 months

    Incidence of Periapical radiolucency or widening and Resorption

Sponsors and collaborators

Lead sponsor

Liaquat College of Medicine and Dentistry

Other

Collaborators

  • Ziauddin University

Registry information

Official study title

Comparison of Efficacy of Platelet-rich Fibrin, Mineral Trioxide Aggregate and Calcium Hydroxide as Pulpotomy Medicaments in Permanent Teeth With Irreversible Pulpitis

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 4, 2022
Registry last updated
Aug 17, 2022

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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