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

Phase 2

Completed

• Conditions: Pulpitis - Irreversible; Tooth Decay
• Interventions: Other: Calcium hydroxide; Other: PRF; Other: MTA

• Registration Number: NCT05266859
• Lead Sponsor: Liaquat College of Medicine and Dentostry

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-28
• Primary Completion: 2021-07-14
• Study Completion: 2022-01-14
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I- Calcium hydroxide (Control)	Calcium hydroxide	Group I will receive Calcium hydroxide . Calcium hydroxide is a gold standard medicament for the pulpotomy in deciduous teeth. It has antibacterial effects and widely used to disinfect the root canals. This group will act as a control
Group III- PRF (Experimental)	PRF	Group III will receive PRF. PRF is platelet-rich fibrin that is a biocompatible product derived from patient's own blood. It is formed by centrifugation of the blood of the patient. It provides the growth factors and promotes regeneration of the pulp
Group II- MTA (Experimental)	MTA	Group II will receive MTA (Mineral Trioxide Aggregate). MTA is a calcium silicate based highly biocompatible material that is commonly used for pulpotomies in deciduous teeth along with the regenerative procedures in permanent and deciduous teeth

Primary Outcome Measures

Name	Time	Method
Clinical Success or Failure	12 months	Incidence of pain, swelling, sinus tract formation, tenderness to percussion after specified time period after intervention
Radiographic Success or Failure	12 months	Incidence of Periapical radiolucency or widening and Resorption

Trial Locations

Locations (1)

Liaquat College of Medicine and Dentistry; 🇵🇰 Karachi, Sindh, Pakistan