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

Sponsor

Liaquat College of Medicine and Dentostry (Other)

Overall Status

Completed

CT.gov ID

NCT05266859

Collaborator

Ziauddin University (Other)

114

Enrollment

Location

Arms

28.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pulpitis - Irreversible Tooth Decay	Other: Calcium hydroxide Other: MTA Other: PRF	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 28, 2019

Actual Primary Completion Date :

Jul 14, 2021

Actual Study Completion Date :

Jan 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I- Calcium hydroxide (Control) 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	Other: Calcium hydroxide Calcium hydroxide in the power/liquid form will be used and placed on the exposed pulp
Experimental: Group II- MTA (Experimental) 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	Other: MTA Mineral trioxide aggregate will be used as a powder / liquid form and placed over the exposed pulp
Experimental: Group III- PRF (Experimental) 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	Other: PRF PRF will be placed directly over the exposed pulp

Arm

Intervention/Treatment

Active Comparator: Group I- Calcium hydroxide (Control)

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

Other: Calcium hydroxide

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

Experimental: Group II- MTA (Experimental)

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

Other: MTA

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

Experimental: Group III- PRF (Experimental)

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

Other: PRF

PRF will be placed directly over the exposed pulp

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.