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

Primary Purpose

Pulpitis - Irreversible, Tooth Decay

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Calcium hydroxide
MTA
PRF
Sponsored by
Liaquat College of Medicine and Dentostry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring MTA, Calcium Hydroxide, PRF, Pulpotomy, Irreversible pulpitis, Permanent teeth, Medicament

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Liaquat College of Medicine and Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group I- Calcium hydroxide (Control)

Group II- MTA (Experimental)

Group III- PRF (Experimental)

Arm Description

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 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 18, 2022
Last Updated
August 16, 2022
Sponsor
Liaquat College of Medicine and Dentostry
Collaborators
Ziauddin University
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1. Study Identification

Unique Protocol Identification Number
NCT05266859
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
January 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat College of Medicine and Dentostry
Collaborators
Ziauddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible, Tooth Decay
Keywords
MTA, Calcium Hydroxide, PRF, Pulpotomy, Irreversible pulpitis, Permanent teeth, Medicament

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I- Calcium hydroxide (Control)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group II- MTA (Experimental)
Arm Type
Experimental
Arm Description
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
Arm Title
Group III- PRF (Experimental)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Calcium hydroxide
Intervention Description
Calcium hydroxide in the power/liquid form will be used and placed on the exposed pulp
Intervention Type
Other
Intervention Name(s)
MTA
Intervention Description
Mineral trioxide aggregate will be used as a powder / liquid form and placed over the exposed pulp
Intervention Type
Other
Intervention Name(s)
PRF
Intervention Description
PRF will be placed directly over the exposed pulp
Primary Outcome Measure Information:
Title
Clinical Success or Failure
Description
Incidence of pain, swelling, sinus tract formation, tenderness to percussion after specified time period after intervention
Time Frame
12 months
Title
Radiographic Success or Failure
Description
Incidence of Periapical radiolucency or widening and Resorption
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Liaquat College of Medicine and Dentistry
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75290
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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