Hypomineralization Molar IncisorLTAFTIDHTNCT03823170
Laser Therapy and Flouride Therapy in Desensibilization Hypomineralized Teeth
A study testing Laser therapy, Fluorotherapy and Laser therapy and Fluorotherapy in people with Hypomineralization Molar Incisor, run by Universidade Ceuma at 1 site in Brazil.
Trial summary
To investigate the efficacy of laser therapy associated with fluorotherapy in the desensibitization of hypomineralized teeth in children 8 to 12 years of age. A randomized blinded clinical trial will be conducted. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypomineralization Molar Incisor
- What is being tested?
- Laser therapy, Fluorotherapy and Laser therapy and Fluorotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2018to 23 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from 8 to 12 years of age;
- At least one first permanent or incisive erupted incisor (with occlusal / incisal surface free of gingiva) present in the oral cavity;
- Teeth presenting hypomineralization lesions sensitive.
Who cannot join
- Children with enamel malformations linked to syndromes, with dental fluorosis, enamel hypoplasia or with imperfect amelogenesis;
- Teeth with loss of dental structure and carious lesion;
- Children in orthodontic treatment;
- Children with cognition problems;
- Children who used any type of analgesic / anti-inflammatory medication before treatment;
- Children undergoing desensitizing treatment in the last 3 months
- Children with behavioral problems;
- Children with occlusal problems such as tightening and bruxism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Laser Therapy Associated With Fluoride Therapy in Hypomineralized Teeth Desensibilization: Randomized Clinical Trial
To investigate the efficacy of laser therapy associated with fluorotherapy in the desensibitization of hypomineralized teeth in children 8 to 12 years of age. A randomized blinded clinical trial will be conducted. The instruments used will be a questionnaire general, clinical examination, dental air syringe (evaluation of dental sensitivity) and visual analogue scale (evaluation of the magnitude of dental sensitivity). Teeth with hypomineralization molar-incisor (HMI) and the results of sensitivity and magnitude of dental pain before and after the treatments will be recorded in a clinical record. The study groups will be: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3).
Read the detailed description
A blinded randomized clinical trial will be conducted. The study will be conducted with children attending the Pediatric Dentistry Clinic of the Florence Institute's undergraduate course, in São Luís, Maranhão, Brazil. As inclusion criteria, children from 8 to 12 years of age will be adopted, with at least one first permanent or incisive erupted incisor (with occlusal / incisal surface free of gingiva) present in the oral cavity and presenting sensitive hypomineralization lesions. Exclusion criteria will be children with enamel malformations linked to syndromes, with dental fluorosis, enamel hypoplasia or with imperfect amelogenesis, teeth with loss of structure dental and carious lesions, children in orthodontic treatment, children with cognition problems, children who used any type of analgesic / anti-inflammatory medication before treatment, children undergoing desensitizing treatment in the last 3 months, children with behavioral problems and children with occlusal problems such as tightening and bruxism.
The instruments of data collection will be a general questionnaire (demographic, socioeconomic and etiological factors for HMI), clinical examination for diagnosis of HMI, dental sensitivity test with air syringe and visual analogue scale (to assess the magnitude of pain). In a clinical file will be recorded the teeth with HMI, the result of the sensitivity test and magnitude of dental pain before and after treatments. The general questionnaire will be answered by the parents / guardians. In cases of incomplete questionnaires, parents / guardians will be contacted by telephone.
The diagnosis of HMI will be performed according to the criteria proposed by the European Academy of Child Dentistry (WEERHEIJM et al., 2003). The researcher will be calibrated for the application of the questionnaire and for the diagnosis of HMI lesions.
The study groups will be: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3). For the treatment of group 1, the low-power, infrared (808nm wavelength) diode laser with a power of 100mW will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site. The treatment of Group 2 will be carried out with the application of fluoride varnish, with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions. Group 3 will be treated first with the laser (same specifications as Group 1), followed by application of fluoride varnish (same specifications as Group 2).
- Conditions
- Hypomineralization Molar Incisor
- Being tested
- Laser therapy, Fluorotherapy, Laser therapy and Fluorotherapy
- Keywords
- hypomineralization molar incisor, Child, Laser Therapy, Tooth Sensitivity
- Medical subject headings
- Molar Hypomineralization, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyRadiation
The low-power, infrared (808nm wavelength) diode laser with a power of 100mW will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site.
FluorotherapyProcedure or surgery
The treatment will be carried out with the application of fluoride varnish, with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions.
Laser therapy and FluorotherapyCombination product
This group will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy).
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy | Experimental | The low-power, infrared (808nm wavelength) diode laser with a power of 100mW (Therapy EC, DMC) will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site. Receives: Radiation: Laser therapy |
| Fluorotherapy | Active comparator | The treatment will be carried out with the application of fluoride varnish (Duraphat), with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions. Receives: Procedure: Fluorotherapy |
| Laser therapy and fluorotherapy | Experimental | The teeth will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy). Receives: Combination Product: Laser therapy and Fluorotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental sensitivity
The dental sensitivity will be evaluated with air from the dental syringe.
Measured: 1 month after the onset of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Jul 2018
- Primary completion23 Dec 2018
- Study completion23 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypomineralization Molar IncisorStudies 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
- Model description
- Groups: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Ceuma
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão
- Responsible party
- Principal investigator, Meire Coelho Ferreira, Universidade Ceuma
- Investigators
- Meire C. Ferreira, PhD, Study director, UniceumaRosyara SC Muniz, DDS, Principal investigator, Uniceuma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823170
- Sponsor's protocol ID
- MCCF-230784-RM
- Acronym
- LTAFTIDHT
- Status last verified
- Nov 2019
- First submitted
- 28 Jan 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghanim A, Silva MJ, Elfrink MEC, Lygidakis NA, Marino RJ, Weerheijm KL, Manton DJ. Molar incisor hypomineralisation (MIH) training manual for clinical field surveys and practice. Eur Arch Paediatr Dent. 2017 Aug;18(4):225-242. doi: 10.1007/s40368-017-0293-9. Epub 2017 Jul 18.
PubMed 28721667Lopes AO, Eduardo Cde P, Aranha AC. Clinical evaluation of low-power laser and a desensitizing agent on dentin hypersensitivity. Lasers Med Sci. 2015 Feb;30(2):823-9. doi: 10.1007/s10103-013-1441-z. Epub 2013 Oct 4.
PubMed 24197517Aranha AC, Pimenta LA, Marchi GM. Clinical evaluation of desensitizing treatments for cervical dentin hypersensitivity. Braz Oral Res. 2009 Jul-Sep;23(3):333-9. doi: 10.1590/s1806-83242009000300018.
PubMed 19893971Lygidakis NA, Wong F, Jalevik B, Vierrou AM, Alaluusua S, Espelid I. Best Clinical Practice Guidance for clinicians dealing with children presenting with Molar-Incisor-Hypomineralisation (MIH): An EAPD Policy Document. Eur Arch Paediatr Dent. 2010 Apr;11(2):75-81. doi: 10.1007/BF03262716.
PubMed 20403301Ozgul BM, Saat S, Sonmez H, Oz FT. Clinical evaluation of desensitizing treatment for incisor teeth affected by molar-incisor hypomineralization. J Clin Pediatr Dent. 2013 Winter;38(2):101-5.
PubMed 24683770Palazon MT, Scaramucci T, Aranha AC, Prates RA, Lachowski KM, Hanashiro FS, Youssef MN. Immediate and short-term effects of in-office desensitizing treatments for dentinal tubule occlusion. Photomed Laser Surg. 2013 Jun;31(6):274-82. doi: 10.1089/pho.2012.3405. Epub 2013 May 15.
PubMed 23675985
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Laser Therapy Associated With Fluoride Therapy in Hypomineralized Teeth Desensibilization: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03823170
- Acronym / sponsor ID
- LTAFTIDHT / MCCF-230784-RM
- Conditions
- Hypomineralization Molar Incisor
- Keywords
- hypomineralization molar incisor, Child, Laser Therapy, Tooth Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universidade CeumaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 30 Jan 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.
To investigate the efficacy of laser therapy associated with fluorotherapy in the desensibitization of hypomineralized teeth in children 8 to 12 years of age. A randomized blinded clinical trial will be conducted. The instruments used will be a questionnaire general, clinical examination, dental air syringe (evaluation of dental sensitivity) and visual analogue scale (evaluation of the magnitude of dental sensitivity). Teeth with hypomineralization molar-incisor (HMI) and the results of sensitivity and magnitude of dental pain before and after the treatments will be recorded in a clinical record. The study groups will be: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3).
Detailed description
A blinded randomized clinical trial will be conducted. The study will be conducted with children attending the Pediatric Dentistry Clinic of the Florence Institute's undergraduate course, in São Luís, Maranhão, Brazil. As inclusion criteria, children from 8 to 12 years of age will be adopted, with at least one first permanent or incisive erupted incisor (with occlusal / incisal surface free of gingiva) present in the oral cavity and presenting sensitive hypomineralization lesions. Exclusion criteria will be children with enamel malformations linked to syndromes, with dental fluorosis, enamel hypoplasia or with imperfect amelogenesis, teeth with loss of structure dental and carious lesions, children in orthodontic treatment, children with cognition problems, children who used any type of analgesic / anti-inflammatory medication before treatment, children undergoing desensitizing treatment in the last 3 months, children with behavioral problems and children with occlusal problems such as tightening and bruxism.
The instruments of data collection will be a general questionnaire (demographic, socioeconomic and etiological factors for HMI), clinical examination for diagnosis of HMI, dental sensitivity test with air syringe and visual analogue scale (to assess the magnitude of pain). In a clinical file will be recorded the teeth with HMI, the result of the sensitivity test and magnitude of dental pain before and after treatments. The general questionnaire will be answered by the parents / guardians. In cases of incomplete questionnaires, parents / guardians will be contacted by telephone.
The diagnosis of HMI will be performed according to the criteria proposed by the European Academy of Child Dentistry (WEERHEIJM et al., 2003). The researcher will be calibrated for the application of the questionnaire and for the diagnosis of HMI lesions.
The study groups will be: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3). For the treatment of group 1, the low-power, infrared (808nm wavelength) diode laser with a power of 100mW will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site. The treatment of Group 2 will be carried out with the application of fluoride varnish, with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions. Group 3 will be treated first with the laser (same specifications as Group 1), followed by application of fluoride varnish (same specifications as Group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Groups: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3).
| Arm | Type | Receives |
|---|---|---|
| Laser therapy | Experimental | Radiation: Laser therapyThe low-power, infrared (808nm wavelength) diode laser with a power of 100mW (Therapy EC, DMC) will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site. |
| Fluorotherapy | Active comparator | Procedure: FluorotherapyThe treatment will be carried out with the application of fluoride varnish (Duraphat), with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions. |
| Laser therapy and fluorotherapy | Experimental | Combination Product: Laser therapy and FluorotherapyThe teeth will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children from 8 to 12 years of age;
- At least one first permanent or incisive erupted incisor (with occlusal / incisal surface free of gingiva) present in the oral cavity;
- Teeth presenting hypomineralization lesions sensitive.
Key exclusion criteria (8 listed)
- Children with enamel malformations linked to syndromes, with dental fluorosis, enamel hypoplasia or with imperfect amelogenesis;
- Teeth with loss of dental structure and carious lesion;
- Children in orthodontic treatment;
- Children with cognition problems;
- Children who used any type of analgesic / anti-inflammatory medication before 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 |
|---|---|---|
| Laser therapyThe low-power, infrared (808nm wavelength) diode laser with a power of 100mW will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site. | Radiation | Laser therapy |
| FluorotherapyThe treatment will be carried out with the application of fluoride varnish, with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions. | Procedure or surgery | Fluorotherapy |
| Laser therapy and FluorotherapyThis group will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy). | Combination product | Laser therapy and fluorotherapy |
Primary outcome
Dental sensitivity
Time frame: 1 month after the onset of treatment
The dental sensitivity will be evaluated with air from the dental syringe.
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 Nov 2019.
- Results publication: PubMed 28721667Ghanim A, Silva MJ, Elfrink MEC, Lygidakis NA, Marino RJ, Weerheijm KL, Manton DJ. Molar incisor hypomineralisation (MIH) training manual for clinical field surveys and practice. Eur Arch Paediatr Dent. 2017 Aug;18(4):225-242. doi: 10.1007/s40368-017-0293-9. Epub 2017 Jul 18.
- Results publication: PubMed 24197517Lopes AO, Eduardo Cde P, Aranha AC. Clinical evaluation of low-power laser and a desensitizing agent on dentin hypersensitivity. Lasers Med Sci. 2015 Feb;30(2):823-9. doi: 10.1007/s10103-013-1441-z. Epub 2013 Oct 4.
- Results publication: PubMed 19893971Aranha AC, Pimenta LA, Marchi GM. Clinical evaluation of desensitizing treatments for cervical dentin hypersensitivity. Braz Oral Res. 2009 Jul-Sep;23(3):333-9. doi: 10.1590/s1806-83242009000300018.
- Results publication: PubMed 20403301Lygidakis NA, Wong F, Jalevik B, Vierrou AM, Alaluusua S, Espelid I. Best Clinical Practice Guidance for clinicians dealing with children presenting with Molar-Incisor-Hypomineralisation (MIH): An EAPD Policy Document. Eur Arch Paediatr Dent. 2010 Apr;11(2):75-81. doi: 10.1007/BF03262716.
- Results publication: PubMed 24683770Ozgul BM, Saat S, Sonmez H, Oz FT. Clinical evaluation of desensitizing treatment for incisor teeth affected by molar-incisor hypomineralization. J Clin Pediatr Dent. 2013 Winter;38(2):101-5.
- Results publication: PubMed 23675985Palazon MT, Scaramucci T, Aranha AC, Prates RA, Lachowski KM, Hanashiro FS, Youssef MN. Immediate and short-term effects of in-office desensitizing treatments for dentinal tubule occlusion. Photomed Laser Surg. 2013 Jun;31(6):274-82. doi: 10.1089/pho.2012.3405. Epub 2013 May 15.
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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.
Meire C. Ferreira, PhD study director
Uniceuma
Rosyara SC Muniz, DDS principal investigator
Uniceuma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy, Fluorotherapy and Laser therapy and Fluorotherapy in people with Hypomineralization Molar Incisor, run by Universidade Ceuma at 1 site in Brazil.
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 8 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 Nov 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 Brazil. 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?
Dental sensitivity (time frame: 1 month after the onset of treatment). 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 NCT03823170, which also lists 6 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 Nov 2019.