Laser Therapy and Flouride Therapy in Desensibilization Hypomineralized Teeth

NCT03823170 | Completed DMC

• 1 other identifier: MCCF-230784-RM
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Hypomineralization Molar Incisor

Keywords

hypomineralization molar incisor; Child; Laser Therapy; Tooth Sensitivity

Outcome Measures

Primary Outcomes (1)

• Dental sensitivity

  The dental sensitivity will be evaluated with air from the dental syringe.

  1 month after the onset of treatment

Study Arms (3)

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.

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.

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).

Combination Product: Laser therapy and Fluorotherapy

Interventions

Laser therapy RADIATION

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.

Laser therapy

Fluorotherapy PROCEDURE

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.

Fluorotherapy

Laser therapy and Fluorotherapy COMBINATION_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).

Laser therapy and fluorotherapy

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Ceuma: lead
• Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão: collaborator

Study Sites (1)

Josue Montello, Universidade Ceuma

São Luís, Maranhão, 65075-120, Brazil

Location

Related Publications (6)

• 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.

  PMID: 28721667 RESULT

• 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.

  PMID: 24197517 RESULT

• 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.

  PMID: 19893971 RESULT

• 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.

  PMID: 20403301 RESULT

• 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.

  PMID: 24683770 RESULT

• 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.

  PMID: 23675985 RESULT

MeSH Terms

Conditions

Molar Hypomineralization; Dentin Sensitivity

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Meire C. Ferreira, PhD

  Uniceuma

  STUDY DIRECTOR

• Rosyara SC Muniz, DDS

  Uniceuma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who will evaluate the treatments through the syringe test will be masked as to the type of treatment performed in each patient. The investigator responsible for the treatment and the patient will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Model Details: Groups: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3).

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: July 1, 2018
• Primary Completion: December 23, 2018
• Study Completion: December 23, 2018
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

BR (1)