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

NCT05266859 | Completed Phase 2 DMC

• 1 other identifier: EC/13/17
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Conditions

Pulpitis - Irreversible; Tooth Decay

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Clinical Success or Failure

  Incidence of pain, swelling, sinus tract formation, tenderness to percussion after specified time period after intervention

  12 months

• Radiographic Success or Failure

  Incidence of Periapical radiolucency or widening and Resorption

  12 months

Study Arms (3)

Group I- Calcium hydroxide (Control)

ACTIVE COMPARATOR

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

Group II- MTA (Experimental)

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

Group III- PRF (Experimental)

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

Interventions

Calcium hydroxide OTHER

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

Group I- Calcium hydroxide (Control)

MTA OTHER

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

Group II- MTA (Experimental)

PRF OTHER

PRF will be placed directly over the exposed pulp

Group III- PRF (Experimental)

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat College of Medicine and Dentistry: lead
• Ziauddin University: collaborator

Study Sites (1)

Liaquat College of Medicine and Dentistry

Karachi, Sindh, 75290, Pakistan

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Calcium Hydroxide; Pemetrexed

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Principal and Registrar

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 4, 2022
• Study Start: August 28, 2019
• Primary Completion: July 14, 2021
• Study Completion: January 14, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)