LaserNCT04010929
Efficacy of Er,Cr:YSGG Laser in Partial Pupotomy
A study testing Partial pulpotomy with laser+MTA and Partial pulpotomy with MTA in people with Laser and Tooth, run by Merve Erkmen Almaz at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the efficacy of partial pulpotomy treatment using MTA and Er,Cr:YSGG + MTA in permanent immature molar teeth with deep dentin caries. The study was performed in children aged between 6-15 who had at least one deep dentine caries in permanent immature molar tooth. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- What is being tested?
- Partial pulpotomy with laser+MTA and Partial pulpotomy with MTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2018to 14 Jan 2019
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of immature molar tooth with deep dentin caries.
Who cannot join
- History of any systematic disease Uncompliance with dental treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Er,Cr:YSGG Laser in Partial Pulpotomy Therapy of Permanent Immature Molar Teeth With Deep Dentin Caries
The aim of this study was to compare the efficacy of partial pulpotomy treatment using MTA and Er,Cr:YSGG + MTA in permanent immature molar teeth with deep dentin caries. The study was performed in children aged between 6-15 who had at least one deep dentine caries in permanent immature molar tooth. The patients' therapies were completed in Kırıkkale University, Faculty of Dentistry, Department of Pediatric Dentisry. A total of 90 teeth (caries exposed) were included in the study. According to the treatment, the teeth were randomly divided into two groups: 1. MTA group (n=45), 2. Laser+MTA group (n=45). In the MTA group, after removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl. In the same session, the tooth was restored with resin modified glass ionomer cement and composite resin. In the laser+MTA group, the treatment procedures were the same as the MTA group, and before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area after bleeding control to provide biostimulation. Patients were called for followup appointments at 1, 3, 6 and 12 months after treatment and control radiographs were taken.
- Being tested
- Partial pulpotomy with laser+MTA, Partial pulpotomy with MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial pulpotomy with laser+MTAProcedure or surgery
After removing caries, laser+MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.
Partial pulpotomy with MTAProcedure or surgery
After removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.
| Study group | Role | What they receive |
|---|---|---|
| Laser+MTA group | Experimental | before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area Receives: Procedure: Partial pulpotomy with laser+MTA |
| MTA group | Active comparator | MTA was applied to the exposed area Receives: Procedure: Partial pulpotomy with MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of spontaneous pain, percussion, palpation, mobility, presence of fistula, swelling of the mucosa, loss of lamina dura, internal or external root resorption and periapical radiolucency
Presence of pathological findings were scored as 1, absence was scored as 0
Measured: First, third, sixth and twelfth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start8 Jan 2018
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaserStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Erkmen Almaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merve Erkmen Almaz, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010929
- Sponsor's protocol ID
- KirikkaleUni
- Status last verified
- Jul 2019
- First submitted
- 19 Apr 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Er,Cr:YSGG Laser in Partial Pulpotomy Therapy of Permanent Immature Molar Teeth With Deep Dentin Caries
- ClinicalTrials.gov ID
- NCT04010929
- Acronym / sponsor ID
- KirikkaleUni
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Merve Erkmen AlmazUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 8 Jul 2019 (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 compare the efficacy of partial pulpotomy treatment using MTA and Er,Cr:YSGG + MTA in permanent immature molar teeth with deep dentin caries. The study was performed in children aged between 6-15 who had at least one deep dentine caries in permanent immature molar tooth. The patients' therapies were completed in Kırıkkale University, Faculty of Dentistry, Department of Pediatric Dentisry. A total of 90 teeth (caries exposed) were included in the study. According to the treatment, the teeth were randomly divided into two groups: 1. MTA group (n=45), 2. Laser+MTA group (n=45). In the MTA group, after removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl. In the same session, the tooth was restored with resin modified glass ionomer cement and composite resin. In the laser+MTA group, the treatment procedures were the same as the MTA group, and before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area after bleeding control to provide biostimulation. Patients were called for followup appointments at 1, 3, 6 and 12 months after treatment and control radiographs were taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser+MTA group | Experimental | Procedure: Partial pulpotomy with laser+MTAbefore the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area |
| MTA group | Active comparator | Procedure: Partial pulpotomy with MTAMTA was applied to the exposed area |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical diagnosis of immature molar tooth with deep dentin caries.
Key exclusion criteria (1 listed)
- History of any systematic disease Uncompliance with dental treatment
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 pulpotomy with laser+MTAAfter removing caries, laser+MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl. | Procedure or surgery | Laser+MTA group |
| Partial pulpotomy with MTAAfter removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl. | Procedure or surgery | MTA group |
Primary outcome
presence of spontaneous pain, percussion, palpation, mobility, presence of fistula, swelling of the mucosa, loss of lamina dura, internal or external root resorption and periapical radiolucency
Time frame: First, third, sixth and twelfth month
Presence of pathological findings were scored as 1, absence was scored as 0
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 8 Jul 2019.
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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 study testing Partial pulpotomy with laser+MTA and Partial pulpotomy with MTA in people with Laser and Tooth, run by Merve Erkmen Almaz 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 8 Jul 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?
presence of spontaneous pain, percussion, palpation, mobility, presence of fistula, swelling of the mucosa, loss of lamina dura, internal or external root resorption and periapical radiolucency (time frame: First, third, sixth and twelfth month). 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 8 Jul 2019.