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

Pulpitis - Irreversible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266859
• Other study ID #: EC/13/17
• Status: Completed
• Phase: Phase 2
• Start date: August 28, 2019
• Est. completion date: January 14, 2022

Study information

• Verified date: August 2022
• Source: Liaquat College of Medicine and Dentostry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 14, 2022
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible
• Tooth Decay

Intervention

Other:
• Calcium hydroxide
Calcium hydroxide in the power/liquid form will be used and placed on the exposed pulp
• MTA
Mineral trioxide aggregate will be used as a powder / liquid form and placed over the exposed pulp
• PRF
PRF will be placed directly over the exposed pulp

Locations

Country	Name	City	State
Pakistan	Liaquat College of Medicine and Dentistry	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Liaquat College of Medicine and Dentostry	Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success or Failure	Incidence of pain, swelling, sinus tract formation, tenderness to percussion after specified time period after intervention	12 months
Primary	Radiographic Success or Failure	Incidence of Periapical radiolucency or widening and Resorption	12 months