Pulpitis - IrreversiblePhase 2NCT05266859
Efficacy of PRF and MTA as Compared to Calcium Hydroxide for Pulpotomy in Human Irreversibly Inflamed Permanent Teeth
A Phase 2 study testing Calcium hydroxide, MTA and PRF in people with Pulpitis - Irreversible and Tooth Decay, run by Liaquat College of Medicine and Dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible, Tooth Decay
- What is being tested?
- Calcium hydroxide, MTA and PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Aug 2019to 14 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Liaquat College of Medicine and Dentistry
Karachi, Sindh, 75290
About this study
Official title: Comparison of Efficacy of Platelet-rich Fibrin, Mineral Trioxide Aggregate and Calcium Hydroxide as Pulpotomy Medicaments in Permanent Teeth With Irreversible Pulpitis
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
- Being tested
- Calcium hydroxide, MTA, PRF
- Keywords
- MTA, Calcium Hydroxide, PRF, Pulpotomy, Irreversible pulpitis, Permanent teeth, Medicament
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium hydroxideOther
Calcium hydroxide in the power/liquid form will be used and placed on the exposed pulp
MTAOther
Mineral trioxide aggregate will be used as a powder / liquid form and placed over the exposed pulp
PRFOther
PRF will be placed directly over the exposed pulp
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success or Failure
Incidence of pain, swelling, sinus tract formation, tenderness to percussion after specified time period after intervention
Measured: 12 months
Radiographic Success or Failure
Incidence of Periapical radiolucency or widening and Resorption
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start28 Aug 2019
- Primary completion14 Jul 2021
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat College of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Collaborators
- Ziauddin University
- Responsible party
- Principal investigator, Naheed Najmi, Liaquat College of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266859
- Sponsor's protocol ID
- EC/13/17
- Status last verified
- Aug 2022
- First submitted
- 18 Feb 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Platelet-rich Fibrin, Mineral Trioxide Aggregate and Calcium Hydroxide as Pulpotomy Medicaments in Permanent Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05266859
- Acronym / sponsor ID
- EC/13/17
- Conditions
- Pulpitis - Irreversible, Tooth Decay
- Keywords
- MTA, Calcium Hydroxide, PRF, Pulpotomy, Irreversible pulpitis, Permanent teeth, Medicament
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Liaquat College of Medicine and DentistryUniversity, hospital or other
- Collaborators
- Ziauddin University
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I- Calcium hydroxide (Control) | Active comparator | Other: Calcium hydroxideGroup 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- MTA (Experimental) | Experimental | Other: MTAGroup 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- PRF (Experimental) | Experimental | Other: PRFGroup 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 |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (15 listed)
- CLINICALLY Teeth with
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium hydroxideCalcium hydroxide in the power/liquid form will be used and placed on the exposed pulp | Other | Group I- Calcium hydroxide (Control) |
| MTAMineral trioxide aggregate will be used as a powder / liquid form and placed over the exposed pulp | Other | Group II- MTA (Experimental) |
| PRFPRF will be placed directly over the exposed pulp | Other | Group III- PRF (Experimental) |
Primary outcome
Clinical Success or Failure
Time frame: 12 months
Incidence of pain, swelling, sinus tract formation, tenderness to percussion after specified time period after intervention
Radiographic Success or Failure
Time frame: 12 months
Incidence of Periapical radiolucency or widening and Resorption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium hydroxide, MTA and PRF in people with Pulpitis - Irreversible and Tooth Decay, run by Liaquat College of Medicine and Dentistry at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success or Failure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.