Clinical trial NCT05266859: Efficacy of PRF and MTA as Compared to Calcium Hydroxide for Pulpotomy in Human Irreversibly Inflamed Permanent Teeth
Official title: Comparison of Efficacy of Platelet-rich Fibrin, Mineral Trioxide Aggregate and Calcium Hydroxide as Pulpotomy Medicaments in Permanent Teeth With Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulpitis - Irreversible
Tooth Decay
Keywords: MTA
Calcium Hydroxide
PRF
Pulpotomy
Irreversible pulpitis
Permanent teeth
Medicament
Lead sponsor: Liaquat College of Medicine and Dentostry
Sponsor class: OTHER
Collaborators: name: Ziauddin University
First posted: 2022-03-04
Enrollment: 114
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success or Failure
timeFrame: 12 months
measure: Radiographic Success or Failure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Liaquat College of Medicine and Dentistry
state: Sindh
Study officials:
References: