Evaluation of the Effectiveness of Various Desensitizing Treatment Protocols

NCT07085689 | Completed

• 1 other identifier: HUDHF-MIH-desensitization
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research was to evaluate the clinical success of desensitization treatments using four different materials in the first permanent molars (FPMs) affected by MIH.

Conditions

Molar Incisor Hypomineralization

Keywords

molar incisor hypomineralization; hypersensitivity; desensitization

Outcome Measures

Primary Outcomes (2)

• Schiff Cold Air Sensitivity Scale for air sensitivity

  Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. The The Schiff Cold Air Sensitivity Scale (SCASS) was used by the examiner to assess the subjects' response to this stimulus. Scoring was performed as follows: 0=subject does not respond to air stimulus; 1=subject responds to air stimulus but does not request discontinuation of stimulus; 2=subject responds to air stimulus and requests discontinuation or moves away from stimulus; and 3=subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

  6 months

• Wong-Baker Pain Rating Scale for tactile sensitivity

  Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. Tactile hypersensitivity was assessed by scratching on the surface of the MIH-affected tooth with a dental explorer (max. twice scratches back and forth). The children scored pain intensity with the Wong Baker Faces Scale (WBFS) (0 = no hurt and 10 = hurts worst).

  6 months

Secondary Outcomes (1)

• Hypersensitivity during tooth brushing, consumption of hot/cold/sweet/sour foods and beverages or during breathing

  6 months

Study Arms (4)

5% Sodium Fluoride Varnish

ACTIVE COMPARATOR

After isolating and drying the teeth to be treated using cotton rolls, 5% sodium fluoride (NaF) varnish (Proshield Varnish, President Dental, Munich, Germany) was applied to the tooth surfaces in two thin layers with the help of a disposable microbrush. The cotton rolls were then removed to allow the varnish to come into contact with saliva and harden. After the procedure, participants were advised to avoid consuming hard foods and brushing their teeth for 4 to 6 hours.

Device: Sodium Fluoride Varnish (5%)

Silver Diamine Fluoride

ACTIVE COMPARATOR

After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% silver diamine fluoride (Riva Star, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet.

Device: Silver diamine fluoride- potassium iodide

Aqueous Silver Fluoride

ACTIVE COMPARATOR

After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% aqueous silver fluoride (Riva Star Aqua, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet.

Device: Aqueous Silver Fluoride

Hydroxyethyl Methacrylate and Glutaraldehyde (Gluma)

ACTIVE COMPARATOR

After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. One to two drops of a desensitizing agent containing hydroxyethyl methacrylate and glutaraldehyde (Gluma, Heraeus Kulzer GmbH, Hanau, Germany) were applied to the tooth surface using a disposable microbrush in a rubbing motion. After waiting for 30-60 seconds, the tooth surface was completely dried until the liquid disappeared and the surface lost its shine, and then rinsed with water.

Device: Hydroxyethyl Methacrylate and Glutaraldehyde

Interventions

Sodium Fluoride Varnish (5%) DEVICE

After isolating and drying the teeth to be treated using cotton rolls, 5% sodium fluoride (NaF) varnish (Proshield Varnish, President Dental, Munich, Germany) was applied to the tooth surfaces in two thin layers with the help of a disposable microbrush. The cotton rolls were then removed to allow the varnish to come into contact with saliva and harden. After the procedure, participants were advised to avoid consuming hard foods and brushing their teeth for 4 to 6 hours.

Also known as: Proshield Varnish

5% Sodium Fluoride Varnish

Silver diamine fluoride- potassium iodide DEVICE

After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% silver diamine fluoride (Riva Star, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet.

Also known as: Riva Star

Silver Diamine Fluoride

Aqueous Silver Fluoride DEVICE

After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% aqueous silver fluoride (Riva Star Aqua, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet.

Also known as: Riva Star Aqua

Aqueous Silver Fluoride

Hydroxyethyl Methacrylate and Glutaraldehyde DEVICE

After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. One to two drops of a desensitizing agent containing hydroxyethyl methacrylate and glutaraldehyde (Gluma, Heraeus Kulzer GmbH, Hanau, Germany) were applied to the tooth surface using a disposable microbrush in a rubbing motion. After waiting for 30-60 seconds, the tooth surface was completely dried until the liquid disappeared and the surface lost its shine, and then rinsed with water.

Also known as: Gluma Desensitizer

Hydroxyethyl Methacrylate and Glutaraldehyde (Gluma)

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children, aged 7-14 years, who attended the pediatric dentistry clinic regular dental examination
• Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
• Presenting at least one FPMs that were fully erupted and has level 2 or 3 according to the Schiff Cold Air Sensitivity Scale

You may not qualify if:

• Children having hypomineralized FPMs with post-eruptive breakdown, cavitated carious lesions, restorations or fixed orthodontic appliances
• Enamel defect due to a condition other than MIH
• FPMs to be treated must not have been previously treated with a desensitizing agent.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındag, Turkey (Türkiye)

Location

Related Publications (4)

• 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 BACKGROUND

• Cavalcante BGN, Mlinko E, Szabo B, Teutsch B, Hegyi P, Vag J, Nemeth O, Gerber G, Varga G. Non-Invasive Strategies for Remineralization and Hypersensitivity Management in Molar-Incisor Hypomineralization-A Systematic Review and Meta-Analysis. J Clin Med. 2024 Nov 26;13(23):7154. doi: 10.3390/jcm13237154.

  PMID: 39685613 BACKGROUND

• Ballikaya E, Unverdi GE, Cehreli ZC. Management of initial carious lesions of hypomineralized molars (MIH) with silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART): 1-year results of a prospective, randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2197-2205. doi: 10.1007/s00784-021-04236-5. Epub 2021 Nov 6.

  PMID: 34743243 BACKGROUND

• Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.

  PMID: 11641576 BACKGROUND

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 Officials

• Beste Ozgur

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All sensitivity assessments were performed blindly by a researcher who did not know the baseline scores or the treatment administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: four intervention groups, randomized, single-blind clinical trial

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 25, 2025
• Study Start: April 20, 2023
• Primary Completion: January 3, 2025
• Study Completion: May 9, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)