PulpotomyNCT03718676
Pulpotomy With Various MTA Materials and Ferric Sulphate
A study testing Ferric sulphate, Ortho-MTA and Retro-MTA in people with Pulpotomy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine clinical and radiographic efficacy of the newly developed OrthoMTA and RetroMTA , compared frequently used ferric sulfate for pulpotomy in primary second molars. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy
- What is being tested?
- Ferric sulphate, Ortho-MTA and Retro-MTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2017to 30 Dec 2018
- Phase
- Interventional
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients have at least three deep carious primary second molars
- Teeth with no spontaneous pain
- Patient who are willing to participate
- Cooperative children
Who cannot join
- Patients who are not willing to participate
- History of systemic disease
- Pathological mobility
- Presence of internal or external root resorption
- Presence of apical radiolucency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Comparison of RetroMTA, OrthoMTA And Ferric Sulfate for Pulpotomy in Primary Molars
The aim of this study was to determine clinical and radiographic efficacy of the newly developed OrthoMTA and RetroMTA , compared frequently used ferric sulfate for pulpotomy in primary second molars.
Read the detailed description
A total of 96 second primary second molars from 32 children ,who met inclusion criteria and were 5-9 years old were selected for the study. Teeth were randomly divided into three groups according to the planned treatment: O-MTA (n=32 teeth), R-MTA (n=32 teeth) and FS (n=32 teeth). Clinical and radiographical follow-up examinations were conducted at 3, 6 and 9 months postoperatively. The data were evaluated with Chi-square test, Cochran Q test, Post-Huc Dunn test and Kaplan-Meier analysis.
- Conditions
- Pulpotomy
- Being tested
- Ferric sulphate, Ortho-MTA, Retro-MTA
- Keywords
- pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric sulphateProcedure or surgery
Teeth were pulpotomized with ferric sulphate in this group.
Ortho-MTAProcedure or surgery
Teeth were pulpotomized with Ortho-MTA in this group.
Retro-MTAProcedure or surgery
Teeth were pulpotomized with Retro-MTA in this group.
| Study group | Role | What they receive |
|---|---|---|
| Ferric sulphate | Other | Group FS. Teeth in this goup will pulpotomized with ferris-sulphate. Receives: Procedure: Ferric sulphate |
| Orto-mta | Experimental | Group O-MTA.Teeth in this goup will pulpotomized with Ortho-mta. Receives: Procedure: Ortho-MTA |
| Retro-mta | Experimental | Group R-MTA. Teeth in this goup will pulpotomized with Retro-mta. Receives: Procedure: Retro-MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
Clinical success
Measured: Change of clinical success from Baseline at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start2 Jun 2017
- Primary completion30 Jun 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PulpotomyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan KELES, Aydin Adnan Menderes University
- Investigators
- sultan keles, Dr., Principal investigator, Pediatric dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718676
- Sponsor's protocol ID
- 2018-047
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share the results.
Publications
Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.
PubMed 30292451
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Comparison of RetroMTA, OrthoMTA And Ferric Sulfate for Pulpotomy in Primary Molars
- ClinicalTrials.gov ID
- NCT03718676
- Acronym / sponsor ID
- 2018-047
- Conditions
- Pulpotomy
- Keywords
- pulpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 24 Oct 2018 (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 determine clinical and radiographic efficacy of the newly developed OrthoMTA and RetroMTA , compared frequently used ferric sulfate for pulpotomy in primary second molars.
Detailed description
A total of 96 second primary second molars from 32 children ,who met inclusion criteria and were 5-9 years old were selected for the study. Teeth were randomly divided into three groups according to the planned treatment: O-MTA (n=32 teeth), R-MTA (n=32 teeth) and FS (n=32 teeth). Clinical and radiographical follow-up examinations were conducted at 3, 6 and 9 months postoperatively. The data were evaluated with Chi-square test, Cochran Q test, Post-Huc Dunn test and Kaplan-Meier analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ferric sulphate | Other | Procedure: Ferric sulphateGroup FS. Teeth in this goup will pulpotomized with ferris-sulphate. |
| Orto-mta | Experimental | Procedure: Ortho-MTAGroup O-MTA.Teeth in this goup will pulpotomized with Ortho-mta. |
| Retro-mta | Experimental | Procedure: Retro-MTAGroup R-MTA. Teeth in this goup will pulpotomized with Retro-mta. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients have at least three deep carious primary second molars
- Teeth with no spontaneous pain
- Patient who are willing to participate
- Cooperative children
Key exclusion criteria (5 listed)
- Patients who are not willing to participate
- History of systemic disease
- Pathological mobility
- Presence of internal or external root resorption
- Presence of apical radiolucency
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 |
|---|---|---|
| Ferric sulphateTeeth were pulpotomized with ferric sulphate in this group. | Procedure or surgery | Ferric sulphate |
| Ortho-MTATeeth were pulpotomized with Ortho-MTA in this group. | Procedure or surgery | Orto-mta |
| Retro-MTATeeth were pulpotomized with Retro-MTA in this group. | Procedure or surgery | Retro-mta |
Primary outcome
Clinical success rate
Time frame: Change of clinical success from Baseline at 18 months
Clinical success
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 5 Mar 2019.
- Background: PubMed 30292451Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.
- Individual participant dataSharing planned: Undecided. We will share the results.
Related trials for Pulpotomy
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Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
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Pomegranate Peel Extract for Primary Molar Pulpotomy
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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.
sultan keles, Dr. principal investigator
Pediatric dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferric sulphate, Ortho-MTA and Retro-MTA in people with Pulpotomy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 5 Mar 2019. 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 Turkey (Türkiye). 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.
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 rate (time frame: Change of clinical success from Baseline at 18 months). 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 NCT03718676, which also lists 1 linked publication.
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 5 Mar 2019.