Photobiomodulation and New Restorative Material for Teeth With MIH on Control of Hypersensitivity and Longevity

NCT ID: NCT06538142

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-09-01

Brief Summary

Introduction: Molar incisor hypomineralization (MIH) is a qualitative defect of enamel development that occurs in the mineralization phase. MIH affects one or more permanent molars and, occasionally, permanent incisors.

Objective: The aim of the proposed study is to determine whether photobiomodulation combined with a new self-cure resin improves hypersensitivity in molars with MIH and caries (primary outcome). Secondary outcomes include assessing the clinical performance of the self-cure composite resin in terms of restoration longevity and comparing the effectiveness of three interventions-photobiomodulation combined with self-cure resin, self-cure resin alone, and photobiomodulation combined with bulkfill photopolymerizable resin-in controlling hypersensitivity over time.

Methods and analysis: Permanent molars with MIH in patients eight to 12 years of age will be allocated to three groups. Group 1: photobiomodulation + self-cure composite resin restoration; Group 2: self-cure composite resin restoration; Group 3: photobiomodulation + restoration in bulk-fill photopolymerizable composite resin. Photobiomodulation will be performed in a single session involving low-level laser administered to four different points. The laser will be used at a wavelength of 808 nm, power of 100 mW and energy of 1 J per points; irradiance will be 3571 mW/cm², with a total radiant exposure of 35.7 J/cm². Data normality will be checked using the Shapiro-Wilk test, and variance homogeneity will be assessed with the Levene test. Descriptive statistics will be used to present the data, with continuous variables expressed as mean and standard deviation, and categorical variables by relative frequency. To compare the VAS and SCASS scales, repeated measures ANOVA will be employed, considering the 3 groups and 5 time points. Bonferroni adjustment will be applied for post-hoc comparisons. Sphericity will be tested with Mauchly's test, and if violated, Greenhouse-Geisser correction will be applied. A significance level of 0.05 will be adopted. Ethics and dissemination: This protocol received approval from the Human Research Ethics Committee of Nove de Julho University (certificate number: xxxxxxx). The legal guardians of the children will agree to participation by signing a statement of informed consent. The results will be published in a peer-review journal and the data will be made available upon request.

Conditions

Hypomineralization Molar Incisor; Hypersensitivity Dentin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Photobiomodulation + Restoration with self-cure composite resin

The participants will receive photobiomodulation + self-cure composite resin restoration.

Group Type: EXPERIMENTAL

Photobiomodulation + Restoration with Self-cure Composite Resin

Intervention Type: PROCEDURE

1. Initial periapical radiograph;

2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment);

3. Application of photobiomodulation;

4. Relative isolation (lip bumper, cotton roll and aspirator);

5. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria);

6. Cleaning with cotton and water;

7. Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds;

8. Application of mild compressed air on adhesive for 3 seconds;

9. Restoration with self-cure composite resin (Stela; SDI, Melbourne, Vic, Australia) extending to adjacent demarcated opacities;

10. Clinical follow up after 48 hours and at four-month intervals for a period of 12 months;

11. Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months.

Restoration with Self-cure Composite Resin

The participants will receive self-cure composite resin restoration.

Group Type: EXPERIMENTAL

Restoration with Self-cure Composite Resin

Intervention Type: PROCEDURE

1. Initial periapical radiograph;

2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment);

3. Relative isolation (lip bumper, cotton roll and aspirator);

4. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria);

5. Cleaning with cotton and water;

6. Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds;

7. Application of mild compressed air on adhesive for 3 seconds;

8. Restoration with self-cure composite resin (Stela; SDI, Melbourne, Vic, Australia) extending to adjacent demarcated opacities;

9. Clinical follow up after 48 hours and at four-month intervals for a period of 12 months;

10. Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months.

Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin

The participants will receive photobiomodulation + restoration in bulk-fill photopolymerizable composite resin restoration.

Group Type: EXPERIMENTAL

Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin

Intervention Type: PROCEDURE

1. Initial periapical radiograph;

2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment;

3. Relative isolation;

4. Application of photobiomodulation;

5. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria);

6. Selective etching of enamel adjacent to demarcated opacities with 35% phosphoric acid for 20s;

7. Active application of universal adhesive (Ambar) on dentin and enamel for 20 seconds (repeat procedure);

8. Application of mild compressed air on adhesive for 5 seconds;

9. Photoactivation for 10s;

10. Restoration with Tetric N Ceram bulk-fill composite resin; with increments up to 4 mm, extending to demarcated opacities;

11. Photoactivation for 10 seconds;

12. Clinical follow up after 48 hours and at four-month intervals for a period of 12 months;

13. Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months.

Interventions

Photobiomodulation + Restoration with Self-cure Composite Resin

1. Initial periapical radiograph;

2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment);

3. Application of photobiomodulation;

4. Relative isolation (lip bumper, cotton roll and aspirator);

5. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria);

6. Cleaning with cotton and water;

7. Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds;

8. Application of mild compressed air on adhesive for 3 seconds;

9. Restoration with self-cure composite resin (Stela; SDI, Melbourne, Vic, Australia) extending to adjacent demarcated opacities;

10. Clinical follow up after 48 hours and at four-month intervals for a period of 12 months;

11. Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months.

Intervention Type: PROCEDURE

Restoration with Self-cure Composite Resin

1. Initial periapical radiograph;

2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment);

3. Relative isolation (lip bumper, cotton roll and aspirator);

4. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria);

5. Cleaning with cotton and water;

6. Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds;

7. Application of mild compressed air on adhesive for 3 seconds;

8. Restoration with self-cure composite resin (Stela; SDI, Melbourne, Vic, Australia) extending to adjacent demarcated opacities;

9. Clinical follow up after 48 hours and at four-month intervals for a period of 12 months;

10. Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months.

Intervention Type: PROCEDURE

Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin

1. Initial periapical radiograph;

2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment;

3. Relative isolation;

4. Application of photobiomodulation;

5. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria);

6. Selective etching of enamel adjacent to demarcated opacities with 35% phosphoric acid for 20s;

7. Active application of universal adhesive (Ambar) on dentin and enamel for 20 seconds (repeat procedure);

8. Application of mild compressed air on adhesive for 5 seconds;

9. Photoactivation for 10s;

10. Restoration with Tetric N Ceram bulk-fill composite resin; with increments up to 4 mm, extending to demarcated opacities;

11. Photoactivation for 10 seconds;

12. Clinical follow up after 48 hours and at four-month intervals for a period of 12 months;

13. Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male and female children;
• Eight to 12 years of age;
• At least one permanent first molar with MIH (codes 5 and 6 of molar-incisor hypomineralization severity scoring system [MIH-SSS])
• Presence of hypersensitivity
• Direct viewing and access.

Exclusion Criteria

• Clinically: signs or symptoms of pulp involvement;
• Radiographically: evidence of pulp involvement (initial periapical radiograph);
• Teeth with MIH with no indication for direct restorative treatment (multiple surfaces associated with large extensions);
• Partially erupted teeth;
• Previous restorative treatment.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Ribeiro CDPV, Mandetta ARH, Pernomiam FC, Camargo CCB, Romano IMF, Sobral APT, Leal ML, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Duran CCG, Bussadori SK. Assessment of photobiomodulation combined with new restorative material for teeth with molar incisor hypomineralization on control of hypersensitivity and longevity of restorations: Protocol for a randomized controlled blind clinical trial. PLoS One. 2025 Aug 13;20(8):e0329641. doi: 10.1371/journal.pone.0329641. eCollection 2025.

Reference Type: DERIVED

PMID: 40802785 (View on PubMed)

Other Identifiers

NewRestorativeMaterial

Identifier Type: -

Identifier Source: org_study_id