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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05266859
Enrollment
114
Registered
2022-03-04
Start date
2019-08-28
Completion date
2022-01-14
Last updated
2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible, Tooth Decay

Keywords

MTA, Calcium Hydroxide, PRF, Pulpotomy, Irreversible pulpitis, Permanent teeth, Medicament

Brief 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

Interventions

OTHERCalcium hydroxide

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

OTHERMTA

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

OTHERPRF

PRF will be placed directly over the exposed pulp

Sponsors

Ziauddin University
CollaboratorOTHER
Liaquat College of Medicine and Dentistry
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Success or Failure12 monthsIncidence of pain, swelling, sinus tract formation, tenderness to percussion after specified time period after intervention
Radiographic Success or Failure12 monthsIncidence of Periapical radiolucency or widening and Resorption

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026