Pulpitis - IrreversiblePhase 4NCT04773886
Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine. .
A Phase 4 study testing Mineral trioxide aggregate, Biodentine and Platelet rich fibrin in people with Pulpitis - Irreversible, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
Trial summary
The aim of this study was to clinically and radiographically evaluate the effectiveness of MTA, Biodentine, Platelet Rich Fibrin along with Mineral Trioxide Aggregate and Platelet Rich Fibrin along with Biodentine as pulpotomy medicament in patients with pulpitis. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Mineral trioxide aggregate, Biodentine and Platelet rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2020to 12 Mar 2021
- Phase
- Phase 4
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with carious exposed tooth exhibiting clinical and radiographical evidence for pulpitis.
- Deep caries extending ≥2/3 of dentin.
- Tooth with positive response with cold testing.
- Tooth with no mobility.
- No signs of pulpal necrosis including sinus tract or swelling.
- Patient approval for the treatment and follow up
Who cannot join
- Any systemic disease that could influence the outcome.
- Non-restorable tooth.
- Teeth with periapical widening.
- Tooth which cannot be isolated.
- Teeth with marginal periodontitis or crestal bone loss.
- Indication of post/ post and core restoration marginal periodontitis with attachment loss >5mm.
Show all 13Show fewer
- Teeth with immature root or calcified canal.
- Teeth with internal and external resorption.
- No pulp exposure after caries excavation.
- Uncontrolled bleeding after access cavity preparation after several minutes N
- No bleeding at all at the time of access opening
- Pregnant or nursing women.
- Individual hypersensitive or allergic to any product used in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.
Ambāla, Haryana, 133207
About this study
Official title: To Evaluate the Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine as Pulpotomy Medicament in Patients With Pulpitis.
The aim of this study was to clinically and radiographically evaluate the effectiveness of MTA, Biodentine, Platelet Rich Fibrin along with Mineral Trioxide Aggregate and Platelet Rich Fibrin along with Biodentine as pulpotomy medicament in patients with pulpitis.
Read the detailed description
Sixty systemically healthy patients with irreversible pulpitis were enrolled in the study based on inclusion and exclusion criteria. All the enrolled patients were randomly allocated into 4 groups (15 each)
Group I: MTA GROUP: Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent. Group II: BIODENTINE GROUP: Vital Pulpotomy will be done using Biodentine as pulp capping agent. Group III: PRF + MTA GROUP: Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent. Group IV: PRF+ BIODENTINE GROUP: Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent Patients were assessed at 1 day,3 months, 6 months and 9 months postoperatively for pain, pulp sensitivity test, swelling or presence of any sinus tract. All the proposed teeth were assessed radiographically at1 day, 3 months, 6 months and 9 months postoperatively.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Mineral trioxide aggregate, Biodentine, Platelet rich fibrin
- Keywords
- pulpal regeneration, pulpitis, pulpotomy
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral trioxide aggregateDrug
Also called MTA
Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent
BiodentineDrug
Also called Biodenine
Vital Pulpotomy will be done using Biodentine as pulp capping agent
Platelet rich fibrinBiological
10 ml of blood was drawn from the peripheral vein in the selected patients with the help of sterilized disposable syringe and blood was collected in the pre-sterilized borosilicate glass test tube, without any addition of anticoagulant and was immediately centrifuged at 3000 rpm for 15 minutes in a centrifuge unit.
The product obtained after centrifugation consisted of three layers:
- Acellular platelet plasma- top most layer
- Platelet rich fibrin -middle layer
- Red blood corpuscles- bottom layer PRF was then separated from the red blood corpuscles base with the help of sterile tweezers and scissors and squeezed with the help of sterile gauze piece
| Study group | Role | What they receive |
|---|---|---|
| MTA GROUP | Sham comparator | Vital Pulpotomy will be done using Mineral trioxide aggregate(MTA) as pulp capping agent. Receives: Drug: Mineral trioxide aggregate |
| BIODENTINE GROUP | Sham comparator | Vital Pulpotomy will be done using Biodentine as pulp capping agent. Receives: Drug: Biodentine |
| PRF + MTA GROUP | Active comparator | Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent Receives: Drug: Mineral trioxide aggregate; Biological: Platelet rich fibrin |
| PRF+ BIODENTINE GROUP | Active comparator | Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent. Receives: Drug: Biodentine; Biological: Platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPT
Electric pulp testing
Measured: change from baseline to 1day, 3 months, 6 months, 9 months
cold test
cold test
Measured: change from baseline to 1day, 3 months, 6 months, 9 months
Secondary outcomes (2)
Tender on percussion
present or absent
Measured: change from baseline to 1day, 3 months, 6 months, 9 months
swelling
present or absent
Measured: change from baseline to 1day, 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Feb 2020
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty systemically healthy patients with irreversible pulpitis were enrolled in the study based on inclusion and exclusion criteria. All the enrolled patients were randomly allocated into 4 groups (15 each) Group I: MTA GROUP: Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent. Group II: BIODENTINE GROUP: Vital Pulpotomy will be done using Biodentine as pulp capping agent. Group III: PRF + MTA GROUP: Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent. Group IV: PRF+ BIODENTINE GROUP: Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- surinder sachdeva, M.D.S., Study director, PROFESSOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773886
- Sponsor's protocol ID
- MahrishiMU 1012
- Status last verified
- Mar 2021
- First submitted
- 22 Feb 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11.
PubMed 30981748Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107.
PubMed 27994420
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine as Pulpotomy Medicament in Patients With Pulpitis.
- ClinicalTrials.gov ID
- NCT04773886
- Acronym / sponsor ID
- MahrishiMU 1012
- Conditions
- Pulpitis - Irreversible
- Keywords
- pulpal regeneration, pulpitis, pulpotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 26 Feb 2021 (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.
The aim of this study was to clinically and radiographically evaluate the effectiveness of MTA, Biodentine, Platelet Rich Fibrin along with Mineral Trioxide Aggregate and Platelet Rich Fibrin along with Biodentine as pulpotomy medicament in patients with pulpitis.
Detailed description
Sixty systemically healthy patients with irreversible pulpitis were enrolled in the study based on inclusion and exclusion criteria. All the enrolled patients were randomly allocated into 4 groups (15 each)
Group I: MTA GROUP: Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent. Group II: BIODENTINE GROUP: Vital Pulpotomy will be done using Biodentine as pulp capping agent. Group III: PRF + MTA GROUP: Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent. Group IV: PRF+ BIODENTINE GROUP: Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent Patients were assessed at 1 day,3 months, 6 months and 9 months postoperatively for pain, pulp sensitivity test, swelling or presence of any sinus tract. All the proposed teeth were assessed radiographically at1 day, 3 months, 6 months and 9 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Sixty systemically healthy patients with irreversible pulpitis were enrolled in the study based on inclusion and exclusion criteria. All the enrolled patients were randomly allocated into 4 groups (15 each) Group I: MTA GROUP: Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent. Group II: BIODENTINE GROUP: Vital Pulpotomy will be done using Biodentine as pulp capping agent. Group III: PRF + MTA GROUP: Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent. Group IV: PRF+ BIODENTINE GROUP: Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.
| Arm | Type | Receives |
|---|---|---|
| MTA GROUP | Sham comparator | Drug: Mineral trioxide aggregateVital Pulpotomy will be done using Mineral trioxide aggregate(MTA) as pulp capping agent. |
| BIODENTINE GROUP | Sham comparator | Drug: BiodentineVital Pulpotomy will be done using Biodentine as pulp capping agent. |
| PRF + MTA GROUP | Active comparator | Drug: Mineral trioxide aggregate, Biological: Platelet rich fibrinVital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent |
| PRF+ BIODENTINE GROUP | Active comparator | Drug: Biodentine, Biological: Platelet rich fibrinVital Pulpotomy will be done using PRF and Biodentine as pulp capping agent. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with carious exposed tooth exhibiting clinical and radiographical evidence for pulpitis.
- Deep caries extending ≥2/3 of dentin.
- Tooth with positive response with cold testing.
- Tooth with no mobility.
- No signs of pulpal necrosis including sinus tract or swelling.
Key exclusion criteria (13 listed)
- Any systemic disease that could influence the outcome.
- Non-restorable tooth.
- Teeth with periapical widening.
- Tooth which cannot be isolated.
- Teeth with marginal periodontitis or crestal bone loss.
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 |
|---|---|---|
| Mineral trioxide aggregateAlso: MTAVital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent | Drug | MTA GROUP, PRF + MTA GROUP |
| BiodentineAlso: BiodenineVital Pulpotomy will be done using Biodentine as pulp capping agent | Drug | BIODENTINE GROUP, PRF+ BIODENTINE GROUP |
| Platelet rich fibrin10 ml of blood was drawn from the peripheral vein in the selected patients with the help of sterilized disposable syringe and blood was collected in the pre-sterilized borosilicate glass test tube, without any addition of anticoagulant and was immediately centrifuged at 3000 rpm for 15 minutes in a centrifuge unit. The product obtained after centrifugation consisted of three layers: * Acellular platelet plasma- top most layer * Platelet rich fibrin -middle layer * Red blood corpuscles- bottom layer PRF was then separated from the red blood corpuscles base with the help of sterile tweezers and scissors and squeezed with the help of sterile gauze piece | Biological | PRF + MTA GROUP, PRF+ BIODENTINE GROUP |
Primary outcome
EPT
Time frame: change from baseline to 1day, 3 months, 6 months, 9 months
Electric pulp testing
cold test
Time frame: change from baseline to 1day, 3 months, 6 months, 9 months
cold test
2 secondary outcomes
Tender on percussion
Time frame: change from baseline to 1day, 3 months, 6 months, 9 months
swelling
Time frame: change from baseline to 1day, 3 months, 6 months, 9 months
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 16 Mar 2021.
- Background: PubMed 30981748Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11.
- Background: PubMed 27994420Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107.
- 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.
surinder sachdeva, M.D.S. study director
PROFESSOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mineral trioxide aggregate, Biodentine and Platelet rich fibrin in people with Pulpitis - Irreversible, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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 6 inclusion and 13 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 16 Mar 2021. 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 India. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
EPT (time frame: change from baseline to 1day, 3 months, 6 months, 9 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?
On the ClinicalTrials.gov record for NCT04773886, which also lists 2 linked publications.
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 16 Mar 2021.