Low-level-laser TheraphyMIHNCT05344014
Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)
A study testing Photobiomodulation in people with Low-level-laser Theraphy and Anesthesia, Local, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Difficulty in achieving anesthesia in teeth with molar incisor hypomineralisation (MIH) is a frequently reported clinical problem. The effect of low-level laser on the efficacy of anesthesia in teeth with MIH has not been studied yet. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Low-level-laser Theraphy, Anesthesia, Local, Molar Incisor Hypomineralization
- What is being tested?
- Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2022to 1 Apr 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of Molar Incisor Hypoplasia (MIH)
- Maxillary permanent first molars with MIH
- Must be the score 3 of MIH (European Academy of Paediatric Dentistry MIH diagnostic criteria
Who cannot join
- The teeth showing irreversible pulp pathology (according to the American Association of Endodontics)
- The children who had negative or definitely negative behavior
- Allergy to local anesthetics
- Taking any medication that might affect the anesthetic assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Faculty of Dentistry
Kocaeli, 41190
About this study
Official title: Evaluation of the Effect of the Photobiomodulation on the Efficacy of Anesthesia of Maxillary Permanent Molar Teeth With MIH
Difficulty in achieving anesthesia in teeth with molar incisor hypomineralisation (MIH) is a frequently reported clinical problem. The effect of low-level laser on the efficacy of anesthesia in teeth with MIH has not been studied yet. Aim of this study is to evaluate the effect of the Photobiomodulation on the efficacy of anesthesia of maxillary permanent molar teeth with MIH.
Design: The current study was conducted as a prospective, parallel-arm control, randomized, triple-blind clinical trial in children aged between 7to12 years. Maxillary permanent molar teeth with MIH requiring pulpotomy treatment were included. 70 participants were divided randomly into 2 groups as experiment (with PBMT) and control (Placebo) according to the anesthesia technique. In the experimental group, before local infiltration anesthesia was administered, PBMT (a diode laser: 940 nm; continuous mode; 0.5W; 78 J/cm2) was applied perpendicular to the root surface at buccal and palatal area for 60 sec each). In the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated. Evaluation of the pain scores were performed during the access cavity preparation of the pulpotomy treatment using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. Also, additional anesthesia requirements were assessed for both groups while working on the dentin and pulp
- Being tested
- Photobiomodulation, Placebo
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationProcedure or surgery
In experimental groups, before topical anesthesia, PBMT was applied by utilizing a diode laser (EpiX; Biolase technology, inc., USA) with a continuous wavelength of 940 nm on a 400-μm fiber with only biostimulation properties. In accordance with the recommendations of the device's manufacturer, it was applied using circular motions in a manner as slowly as possible (an average of 33-36 circular movements in 60 s)
PlaceboProcedure or surgery
In the control group (placebo), the laser probe was directed to the mucosa for (buccal and palatal area), but not activated, and the sound of the laser device previously recorded on the mobile telephone was played for the same time of experimental group in order to provide similar conditions
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation group | Experimental | In the experimental group, before local infiltration anesthesia was administered, PBMT (a diode laser: 940 nm; continuous mode; 0.5W; 78 J/cm2) was applied perpendicular to the root surface at buccal and palatal area for 60 sec each). Receives: Procedure: Photobiomodulation |
| Placebo Group | Placebo comparator | In the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating efficacy of anesthesia with using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Anesthesia efficacy was evaluated objectively with the FLACC scale during the cavity preparation. Behavioral parameters were recorded during the cavity preparation (dentin cutting handpiece ) FLACC scale comprises of five sub-parameters. They are Face, Legs, Activity, Crying and Consolability. Each sub-parameter is given a pain score of 0 to 2. So total behavioral pain score range 0-10 as follows: 0 = relaxed and comfortable (no pain); 1-3= mild discomfort; 4-6 = moderate pain; and 7-10 = severe discomfort and/or pain. Success was achieved if patients experienced mild pain or no pain during the preparation of the cavity
Measured: Through study completion, an average of 24 weeks
Evaluating need of supplementary anesthesia
The subjects with moderate/higher pain need supplementary anesthesia
Measured: Through study completion, an average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start11 Jan 2022
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low-level-laser TheraphyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulku Sermet Elbay, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344014
- Sponsor's protocol ID
- KAEK/04.bI.05
- Acronym
- MIH
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Topcuoglu HS, Akpinar B. The effect of low-level laser therapy on the success rate of inferior alveolar nerve blocks in mandibular molars with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2021 Oct;54(10):1720-1726. doi: 10.1111/iej.13596. Epub 2021 Aug 2.
PubMed 34241896Ghabraei S, Chiniforush N, Bolhari B, Aminsobhani M, Khosarvi A. The Effect of Photobiomodulation on the Depth of Anesthesia During Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis (Double Blind Randomized Clinical Trial). J Lasers Med Sci. 2018 Winter;9(1):11-14. doi: 10.15171/jlms.2018.03. Epub 2017 Dec 26.
PubMed 29399304Menoncin BLV, Portella PD, Ramos BLM, Assuncao LRDS, de Souza JF, Menezes JVNB. Dental anxiety in schoolchildren with molar incisor hypomineralization-A population-based cross-sectional study. Int J Paediatr Dent. 2019 Sep;29(5):615-623. doi: 10.1111/ipd.12503. Epub 2019 May 6.
PubMed 31009135
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Photobiomodulation on the Efficacy of Anesthesia of Maxillary Permanent Molar Teeth With MIH
- ClinicalTrials.gov ID
- NCT05344014
- Acronym / sponsor ID
- MIH / KAEK/04.bI.05
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 25 Apr 2022 (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.
Difficulty in achieving anesthesia in teeth with molar incisor hypomineralisation (MIH) is a frequently reported clinical problem. The effect of low-level laser on the efficacy of anesthesia in teeth with MIH has not been studied yet. Aim of this study is to evaluate the effect of the Photobiomodulation on the efficacy of anesthesia of maxillary permanent molar teeth with MIH.
Design: The current study was conducted as a prospective, parallel-arm control, randomized, triple-blind clinical trial in children aged between 7to12 years. Maxillary permanent molar teeth with MIH requiring pulpotomy treatment were included. 70 participants were divided randomly into 2 groups as experiment (with PBMT) and control (Placebo) according to the anesthesia technique. In the experimental group, before local infiltration anesthesia was administered, PBMT (a diode laser: 940 nm; continuous mode; 0.5W; 78 J/cm2) was applied perpendicular to the root surface at buccal and palatal area for 60 sec each). In the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated. Evaluation of the pain scores were performed during the access cavity preparation of the pulpotomy treatment using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. Also, additional anesthesia requirements were assessed for both groups while working on the dentin and pulp
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group | Experimental | Procedure: PhotobiomodulationIn the experimental group, before local infiltration anesthesia was administered, PBMT (a diode laser: 940 nm; continuous mode; 0.5W; 78 J/cm2) was applied perpendicular to the root surface at buccal and palatal area for 60 sec each). |
| Placebo Group | Placebo comparator | Procedure: PlaceboIn the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of Molar Incisor Hypoplasia (MIH)
- Maxillary permanent first molars with MIH
- Must be the score 3 of MIH (European Academy of Paediatric Dentistry MIH diagnostic criteria
Key exclusion criteria (4 listed)
- The teeth showing irreversible pulp pathology (according to the American Association of Endodontics)
- The children who had negative or definitely negative behavior
- Allergy to local anesthetics
- Taking any medication that might affect the anesthetic assessment
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 |
|---|---|---|
| PhotobiomodulationIn experimental groups, before topical anesthesia, PBMT was applied by utilizing a diode laser (EpiX; Biolase technology, inc., USA) with a continuous wavelength of 940 nm on a 400-μm fiber with only biostimulation properties. In accordance with the recommendations of the device's manufacturer, it was applied using circular motions in a manner as slowly as possible (an average of 33-36 circular movements in 60 s) | Procedure or surgery | Photobiomodulation group |
| PlaceboIn the control group (placebo), the laser probe was directed to the mucosa for (buccal and palatal area), but not activated, and the sound of the laser device previously recorded on the mobile telephone was played for the same time of experimental group in order to provide similar conditions | Procedure or surgery | Placebo Group |
Primary outcome
Evaluating efficacy of anesthesia with using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Time frame: Through study completion, an average of 24 weeks
Anesthesia efficacy was evaluated objectively with the FLACC scale during the cavity preparation. Behavioral parameters were recorded during the cavity preparation (dentin cutting handpiece ) FLACC scale comprises of five sub-parameters. They are Face, Legs, Activity, Crying and Consolability. Each sub-parameter is given a pain score of 0 to 2. So total behavioral pain score range 0-10 as follows: 0 = relaxed and comfortable (no pain); 1-3= mild discomfort; 4-6 = moderate pain; and 7-10 = severe discomfort and/or pain. Success was achieved if patients experienced mild pain or no pain during the preparation of the cavity
Evaluating need of supplementary anesthesia
Time frame: Through study completion, an average of 24 weeks
The subjects with moderate/higher pain need supplementary anesthesia
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 25 Apr 2022.
- Background: PubMed 34241896Topcuoglu HS, Akpinar B. The effect of low-level laser therapy on the success rate of inferior alveolar nerve blocks in mandibular molars with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2021 Oct;54(10):1720-1726. doi: 10.1111/iej.13596. Epub 2021 Aug 2.
- Background: PubMed 29399304Ghabraei S, Chiniforush N, Bolhari B, Aminsobhani M, Khosarvi A. The Effect of Photobiomodulation on the Depth of Anesthesia During Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis (Double Blind Randomized Clinical Trial). J Lasers Med Sci. 2018 Winter;9(1):11-14. doi: 10.15171/jlms.2018.03. Epub 2017 Dec 26.
- Background: PubMed 31009135Menoncin BLV, Portella PD, Ramos BLM, Assuncao LRDS, de Souza JF, Menezes JVNB. Dental anxiety in schoolchildren with molar incisor hypomineralization-A population-based cross-sectional study. Int J Paediatr Dent. 2019 Sep;29(5):615-623. doi: 10.1111/ipd.12503. Epub 2019 May 6.
- 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.
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 Photobiomodulation in people with Low-level-laser Theraphy and Anesthesia, Local, run by Kocaeli 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 3 inclusion and 4 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 25 Apr 2022. 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. 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.
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?
Evaluating efficacy of anesthesia with using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale (time frame: Through study completion, an average of 24 weeks). 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 NCT05344014, which also lists 3 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 25 Apr 2022.