- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03823170
Laser Therapy and Flouride Therapy in Desensibilization Hypomineralized Teeth (LTAFTIDHT)
Effectiveness of Laser Therapy Associated With Fluoride Therapy in Hypomineralized Teeth Desensibilization: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maranhão
-
São Luis, Maranhão, Brazil, 65075-120
- Josue Montello, Universidade Ceuma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laser therapy
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.
|
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.
|
Active Comparator: Fluorotherapy
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.
|
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.
|
Experimental: Laser therapy and fluorotherapy
The teeth will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy).
|
This group will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental sensitivity
Time Frame: 1 month after the onset of treatment
|
The dental sensitivity will be evaluated with air from the dental syringe.
|
1 month after the onset of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Meire C. Ferreira, PhD, Uniceuma
- Principal Investigator: Rosyara SC Muniz, DDS, Uniceuma
Publications and helpful links
General 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.
- Lopes 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.
- Aranha 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.
- Lygidakis 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.
- Ozgul 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.
- Palazon 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MCCF-230784-RM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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