HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN

NCT06154733 | Unknown

• 1 other identifier: 0774-09/2023
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrically involvement of one to four on first permanent molars (FPM) with or without incisor teeth involvement. Hypersensitivity is one of the biggest challenges in the treatment of MIH. A sample of children having a first permanent molar erupted with MIH and suffering of dentin hypersensitivity (DH). All selected 45 first permanent molars will be randomly equally allocated into three groups. DH will be evaluated after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale. OHRQoL will be also assessed for all children through the child perceptions questionnaire (CPQ8-10).

Conditions

Molar Incisor Hypomineralization

Keywords

Molar Incisor Hypomineralisation, Low Level Laser, Sealant, Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Dentin Hypersensitivity

  it will be measures usinf a Faces pain scale

  Day0, 1 week, 1 month, 3 months and 6 months

Secondary Outcomes (1)

• Oral health related Quality of life (OHRQoL)

  Day 0

Study Arms (3)

Photobiomodulation with low level laser therapy

EXPERIMENTAL

This group will be subjected to photo biomodulation by low level laser therapy. Diode laser will be used (SIROLaser Blue®, Sirona, Germany) at a wavelength of 660 nm and a power of 100 mW for 10 sec, corresponding to an energy dose of 1 J. Irradiation will be performed at the hypomineralized area: two irradiations scanning the surface in the mesiodistal direction and two in the occlusogingival direction (perpendicular to the tooth surface) precisely over the lesion, in a uniform scanning motion with relative isolation. Treatment will be performed in 3 sessions with a 72-hour interval between sessions. During the laser treatments, both the volunteer and operator will use protective eyewear and all rules of safety will be obeyed.

Procedure: Photobiomodulation usinf low level laser therapy

light cured resin-based sealant

ACTIVE COMPARATOR

This group will receive light cured resin-based sealant (Fissured Novo Plus). Cotton rolls and a four-handed technique will be applied for isolation. Scotchbond Universal will be rubbed in the cleaned surface for 20 seconds and air dried for 5 seconds. Afterwards, Fissured Novo Plus will be applied with a syringe. Before light-curing, the presence of air bubbles will be checked and teased out. Light curing for 40 seconds will be done. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.

Procedure: Resin-based sealant

glass ionomer sealant

ACTIVE COMPARATOR

This group will receive glass ionomer sealant. Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.

Procedure: Glass ionomer sealant

Interventions

Photobiomodulation usinf low level laser therapy PROCEDURE

Diode laser will be used (SIROLaser Blue®, Sirona, Germany) at a wavelength of 660 nm and a power of 100 mW for 10 sec, corresponding to an energy dose of 1 J. Irradiation will be performed at the hypomineralized area: two irradiations scanning the surface in the mesiodistal direction and two in the occlusogingival direction (perpendicular to the tooth surface) precisely over the lesion, in a uniform scanning motion with relative isolation. Treatment will be performed in 3 sessions with a 72-hour interval between sessions.

Photobiomodulation with low level laser therapy

Resin-based sealant PROCEDURE

Cotton rolls and a four-handed technique will be applied for isolation. Scotchbond Universal will be rubbed in the cleaned surface for 20 seconds and air dried for 5 seconds. Afterwards, Fissured Novo Plus will be applied with a syringe. Before light-curing, the presence of air bubbles will be checked and teased out. Light curing for 40 seconds will be done. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.

light cured resin-based sealant

Glass ionomer sealant PROCEDURE

Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. For the duration of the study, children will be instructed to undergo regular tooth brushing and flossing. Any other needed treatment will be done for the child.

glass ionomer sealant

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• year-old children (15).
• At least one tooth with MIH and DH reported in the occlusal region with sensitivity equal to or greater than 4 on the Visual analogue Scale (VAS).
• Good overall health (ASA I).

You may not qualify if:

• First permanent molars with active carious lesions or defective restorations
• Sufficient dentin loss that requires restorative therapy.
• Any clinical signs of failure (abscess, fistula).
• Patients with systemic diseases.
• Having undergone any professional desensitizing treatment in the previous 6 months.
• Having used a desensitizing paste in the previous 3 months.
• Use of anti-inflammatory drugs or analgesics at the time of recruitment.

Sponsors & Collaborators

• Alexandria University: lead

MeSH Terms

Conditions

Molar Hypomineralization; Hypersensitivity

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; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of examiners is impossible to be done during intervention due to different natures of the materials. However, the evaluator at follow-up visits, patients and the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Pediatric dentistry department

Model Details: All selected first permanent molars will be randomly equally allocated into three groups. Group 1(n=15): PBM with LLLT, Group 2 (n=15): Resin-based sealant (Fissured Nova Plus) and Group 3 (n=15): Glass ionomer sealant (Ketac).

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-09