Caries, DentalPhase 4NCT03426046
Treatment of Immature Permanent Teeth With Three Different Pulp Capping Materials With Partial Pulpotomy
A Phase 4 study testing Partial Pulpotomy and Pulp Capping Agents in people with Caries, Dental, run by Didem Sakaryali at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled trial is to compare partial pulpotomy treatments with Biodentine®, calcium hydroxide (CH) and Mineral Trioxide Aggregate (MTA) in cariously exposed asymptomatic young permanent teeth clinically and radiographically for 1 year and evaluate root developments with Image J Software… Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- Partial Pulpotomy and Pulp Capping Agents
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2013to 17 Oct 2017
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Deep dentine caries with pulp exposure
Who cannot join
- Pulp exposure without hemorrhage control
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry
Ankara, 06510
About this study
Official title: Partial Pulpotomy Treatment Of Immature Permanent Molars: A Randomized Clinical Trial
The aim of this randomized controlled trial is to compare partial pulpotomy treatments with Biodentine®, calcium hydroxide (CH) and Mineral Trioxide Aggregate (MTA) in cariously exposed asymptomatic young permanent teeth clinically and radiographically for 1 year and evaluate root developments with Image J Software Program. The null hypothesis of this study is Biodentine® will promote healing with high success rates and induce root development more than CH and MTA.
Read the detailed description
The purpose of this study was to evaluate clinical and radiographical success of three different materials in partial pulpotomy treatment. 50 patients with 54 asymptomatic, cariously exposed young permanent mandibular molar teeth were included to the study. The teeth were randomly divided into three main groups which were; calcium hydroxide, MTA and Biodentine® and finally restorated with stainless steel crowns. Pain, percussion sensitivity, palpation sensitivity of soft tissue around the tooth, root development, presence of lesion, integrity of lamina dura were evaluated clinically and radiographically during 12 months and recorded for each. Also, Image J Program with Turbo-Reg plug in was used for standardization of the radiographs and to determine the increase in root length.
- Conditions
- Caries, Dental
- Being tested
- Partial Pulpotomy, Pulp Capping Agents
- Keywords
- Biodentine, Cariously exposed pulp, MTA, Partial pulpotomy, Image J Software
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial PulpotomyProcedure or surgery
Also called Cvek Pulpotomy, Miniature Pulpotomy
Partial removal of inflamed pulp tissue in cariously exposed teeth
Pulp Capping AgentsDrug
Also called Pulp Capping Materials
Biocompatible materials
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | Partial pulpotomy treatment with Biodentine Receives: Procedure: Partial Pulpotomy; Drug: Pulp Capping Agents |
| Calcium Hydroxide | Active comparator | Partial pulpotomy treatment with Calcium Hydroxide Receives: Procedure: Partial Pulpotomy; Drug: Pulp Capping Agents |
| Mineral Trioxide Aggregate | Experimental | Partial pulpotomy treatment with Mineral Trioxide Aggregate Receives: Procedure: Partial Pulpotomy; Drug: Pulp Capping Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root development
Root length measurement in pixels with Image J Software Program
Measured: 12 months
Secondary outcomes (2)
Clinical Evaluation
Percussion sensitivity evaluation with blunt end of a dental instrument comparing with contralateral or next healthy tooth
Measured: 12 months
Radiographical Evaluation
Integrity of lamina dura with visual evaluation of radiopaque line around the root using image plate system
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 posted8 Feb 2018
- Study start22 Nov 2013
- Primary completion30 Apr 2016
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies 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
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Didem Sakaryali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Didem Sakaryali, Gazi University
- Investigators
- Alev Alacam, DDS, PhD, Study chair, Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426046
- Sponsor's protocol ID
- 1047
- Status last verified
- Feb 2018
- First submitted
- 25 Jan 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Pulpotomy Treatment Of Immature Permanent Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03426046
- Acronym / sponsor ID
- 1047
- Conditions
- Caries, Dental
- Keywords
- Biodentine, Cariously exposed pulp, MTA, Partial pulpotomy, Image J Software
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Didem SakaryaliUniversity, hospital or other
- Study start
- 22 Nov 2013 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 8 Feb 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 randomized controlled trial is to compare partial pulpotomy treatments with Biodentine®, calcium hydroxide (CH) and Mineral Trioxide Aggregate (MTA) in cariously exposed asymptomatic young permanent teeth clinically and radiographically for 1 year and evaluate root developments with Image J Software Program. The null hypothesis of this study is Biodentine® will promote healing with high success rates and induce root development more than CH and MTA.
Detailed description
The purpose of this study was to evaluate clinical and radiographical success of three different materials in partial pulpotomy treatment. 50 patients with 54 asymptomatic, cariously exposed young permanent mandibular molar teeth were included to the study. The teeth were randomly divided into three main groups which were; calcium hydroxide, MTA and Biodentine® and finally restorated with stainless steel crowns. Pain, percussion sensitivity, palpation sensitivity of soft tissue around the tooth, root development, presence of lesion, integrity of lamina dura were evaluated clinically and radiographically during 12 months and recorded for each. Also, Image J Program with Turbo-Reg plug in was used for standardization of the radiographs and to determine the increase in root length.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Procedure: Partial Pulpotomy, Drug: Pulp Capping AgentsPartial pulpotomy treatment with Biodentine |
| Calcium Hydroxide | Active comparator | Procedure: Partial Pulpotomy, Drug: Pulp Capping AgentsPartial pulpotomy treatment with Calcium Hydroxide |
| Mineral Trioxide Aggregate | Experimental | Procedure: Partial Pulpotomy, Drug: Pulp Capping AgentsPartial pulpotomy treatment with Mineral Trioxide Aggregate |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Deep dentine caries with pulp exposure
Key exclusion criteria (1 listed)
- Pulp exposure without hemorrhage control
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 |
|---|---|---|
| Partial PulpotomyAlso: Cvek Pulpotomy, Miniature PulpotomyPartial removal of inflamed pulp tissue in cariously exposed teeth | Procedure or surgery | Biodentine, Calcium Hydroxide, Mineral Trioxide Aggregate |
| Pulp Capping AgentsAlso: Pulp Capping MaterialsBiocompatible materials | Drug | Biodentine, Calcium Hydroxide, Mineral Trioxide Aggregate |
Primary outcome
Root development
Time frame: 12 months
Root length measurement in pixels with Image J Software Program
2 secondary outcomes
Clinical Evaluation
Time frame: 12 months
Radiographical Evaluation
Time frame: 12 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 12 Feb 2018.
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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.
Alev Alacam, DDS, PhD study chair
Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry
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 Partial Pulpotomy and Pulp Capping Agents in people with Caries, Dental, run by Didem Sakaryali 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 1 inclusion and 1 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 12 Feb 2018. 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.
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?
Root development (time frame: 12 months). 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 12 Feb 2018.