PulpotomyNCT05680285
Evaluation of Low Level Laser Therapy in Primary Tooth Pulpotomy Treatment
A study testing diode lazer and low level diode laser in people with Pulpotomy, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
In our study, it was aimed to compare the long-term effectiveness of diode laser and low level laser therapy and primary tooth amputation treatments using calcium hydroxide (LLLT+CH) in primary second molars with deep dentinal caries. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy
- What is being tested?
- diode lazer and low level diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 May 2022
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical Criteria
- No systemic disease
- Not allergic to the materials used
- Children with scores of 1 and 2 according to the Frankel behavioral scale
- Those who have erupted permanent first molars
- The one in occlusion with the opposing tooth
Show all 21Show fewer
- Not having bad oral habits
- No structural anomaly in the teeth
- No spontaneous or nocturnal pain
- No sensitivity to palpation or percussion
- Abscess and fistula formation free
- No pathological mobility
- During treatment, pulp bleeding is controlled within 5 minutes.
- With a crown that can be made of stainless steel crown (PÇK)
- Radiographic Criteria
- Having a deep dentin caries lesion very close to the pulp
- No resorption in the bifurcation and periapical area
- Periodontal space is healthy and there is no periapical region pathology
- Absence of internal and external root resorption in roots
- No calcified masses in the pulp
- Teeth that did not exceed one-third of the physiological root resorption were included in the study.
Who cannot join
- -Children with a score of 1 and 4 on the Frankel Scale were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Low Level Laser Therapy in Primary Tooth Pulpotomy Treatment
In our study, it was aimed to compare the long-term effectiveness of diode laser and low level laser therapy and primary tooth amputation treatments using calcium hydroxide (LLLT+CH) in primary second molars with deep dentinal caries. Ninety patients ( 42 Gırl, 48 Boy) aged 6-9 years with deep dentin caries in the mandibular second molar were included in the study. The patients were randomly selected according to the treatment to be applied and divided into two groups as the diode laser group (N=45) and the LLLT+CH group (N=45). The patients were called for control appointments at the 1st, 3rd, 6th and 12th months after the treatment, and both clinical and radiographic follow-ups were performed. Chi-square and Fisher's Exact tests were used to compare categorical variables according to groups in statistical analysis, and p<0.05 was considered significant. When the study results at the end of 12 months were evaluated, the diode laser group had a clinical success rate of 95.6%, and a success rate of 93.3% radiologically; The LLLT+CH group had a success rate of 97.7% clinically and 90.9% radiologically. There was no statistically significant difference between the success rates of the groups (p>0.05). According to the clinical and radiographic results of our study, it was determined that diode laser and LLLT+CH amputations showed similar success rates in primary second molars with deep dentin caries. It has been seen that both methods can be used safely in primary tooth amputations. It is thought that clinical and histological studies and studies examining the effectiveness of dental laser applications in primary tooth amputation treatment are needed.
- Conditions
- Pulpotomy
- Being tested
- diode lazer, low level diode laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode lazerDevice
diode laser was applied during the pulpotomy procedure
low level diode laserDevice
Low-dose diode laser was applied during the pulpotomy procedure
| Study group | Role | What they receive |
|---|---|---|
| diode laser pulpotomy | Experimental | * Diode laser (Solase-976 Dental Diode Laser)
* With a wavelength of 980 nm and a frequency of 110 Hz
* In pulse mode, working for 1 ms and stopping for 8 ms
* With a power output of 1 W during each laser pulse from the 400 µm fiber optic tip
* By touching the fiber optic tip to the remaining pulp tissue
* for 3 seconds
* With 3 J energy to each root pulp during the process Receives: Device: diode lazer |
| low level diode laser pulpotomy | Experimental | * Diode laser (Solase-976 Dental Diode Laser)
* It has a wavelength of 980 nm and a frequency of 165 Hz.
* In pulse mode by setting it to run for 2 ms and stop for 4 ms
* At a power of 0.2 W during each laser pulse from a 400 µm fiber optic tip
* Without the fiber optic tip touching the remaining pulp tissue
* for 10 seconds
* With 2 J Energy to each root pulp Receives: Device: low level diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic success of treatments at the end of 12 months
teeth without any signs of pathological internal and external root resorption, enlargement of the periodontal space, and radiolucency in the periapical and furcation region
Measured: 12 months
clinical success of treatments at the end of 12 months
teeth without any of the signs of spontaneous pain, tenderness on palpation and percussion, pathological mobility, sinus tract or gingival abscess form, lymphodanepathy in the relevant region
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 posted11 Jan 2023
- Study start1 Jan 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpotomyStudies 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tugba YIGIT, Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680285
- Sponsor's protocol ID
- UsakU10
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Low Level Laser Therapy in Primary Tooth Pulpotomy Treatment
- ClinicalTrials.gov ID
- NCT05680285
- Acronym / sponsor ID
- UsakU10
- Conditions
- Pulpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 11 Jan 2023 (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.
In our study, it was aimed to compare the long-term effectiveness of diode laser and low level laser therapy and primary tooth amputation treatments using calcium hydroxide (LLLT+CH) in primary second molars with deep dentinal caries. Ninety patients ( 42 Gırl, 48 Boy) aged 6-9 years with deep dentin caries in the mandibular second molar were included in the study. The patients were randomly selected according to the treatment to be applied and divided into two groups as the diode laser group (N=45) and the LLLT+CH group (N=45). The patients were called for control appointments at the 1st, 3rd, 6th and 12th months after the treatment, and both clinical and radiographic follow-ups were performed. Chi-square and Fisher's Exact tests were used to compare categorical variables according to groups in statistical analysis, and p<0.05 was considered significant. When the study results at the end of 12 months were evaluated, the diode laser group had a clinical success rate of 95.6%, and a success rate of 93.3% radiologically; The LLLT+CH group had a success rate of 97.7% clinically and 90.9% radiologically. There was no statistically significant difference between the success rates of the groups (p>0.05). According to the clinical and radiographic results of our study, it was determined that diode laser and LLLT+CH amputations showed similar success rates in primary second molars with deep dentin caries. It has been seen that both methods can be used safely in primary tooth amputations. It is thought that clinical and histological studies and studies examining the effectiveness of dental laser applications in primary tooth amputation treatment are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diode laser pulpotomy | Experimental | Device: diode lazer* Diode laser (Solase-976 Dental Diode Laser) * With a wavelength of 980 nm and a frequency of 110 Hz * In pulse mode, working for 1 ms and stopping for 8 ms * With a power output of 1 W during each laser pulse from the 400 µm fiber optic tip * By touching the fiber optic tip to the remaining pulp tissue * for 3 seconds * With 3 J energy to each root pulp during the process |
| low level diode laser pulpotomy | Experimental | Device: low level diode laser* Diode laser (Solase-976 Dental Diode Laser) * It has a wavelength of 980 nm and a frequency of 165 Hz. * In pulse mode by setting it to run for 2 ms and stop for 4 ms * At a power of 0.2 W during each laser pulse from a 400 µm fiber optic tip * Without the fiber optic tip touching the remaining pulp tissue * for 10 seconds * With 2 J Energy to each root pulp |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (21 listed)
- Clinical Criteria
- No systemic disease
- Not allergic to the materials used
- Children with scores of 1 and 2 according to the Frankel behavioral scale
- Those who have erupted permanent first molars
Key exclusion criteria (1 listed)
- -Children with a score of 1 and 4 on the Frankel Scale were excluded.
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 |
|---|---|---|
| diode lazerdiode laser was applied during the pulpotomy procedure | Device | diode laser pulpotomy |
| low level diode laserLow-dose diode laser was applied during the pulpotomy procedure | Device | low level diode laser pulpotomy |
Primary outcome
radiographic success of treatments at the end of 12 months
Time frame: 12 months
teeth without any signs of pathological internal and external root resorption, enlargement of the periodontal space, and radiolucency in the periapical and furcation region
clinical success of treatments at the end of 12 months
Time frame: 12 months
teeth without any of the signs of spontaneous pain, tenderness on palpation and percussion, pathological mobility, sinus tract or gingival abscess form, lymphodanepathy in the relevant region
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 11 Jan 2023.
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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.
Tugba YIGIT principal investigator
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diode lazer and low level diode laser in people with Pulpotomy, run by Uşak 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 21 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 11 Jan 2023. 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?
radiographic success of treatments at the end of 12 months (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 11 Jan 2023.