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Completed

NCT Number: NCT07085689

Evaluation of the Effectiveness of Various Desensitizing Treatment Protocols

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.

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Key information

About this study

A total of 121 teeth with a Schiff cold air sensitivity scale (SCASS) score of 2 or 3 were included in 52 children (between 7-14 years). The FPMs were randomized into four groups; 5% sodium fluoride varnish (Group 1), silver diamine fluoride (Group 2), ammonia-free aqueous silver fluoride (Group 3), and hydroxyethyl methacrylate with glutaraldehyde (Group 4). Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. The two methods used at baseline for sensitivity assessment (SCASS for air sensitivity and the Wong-Baker pain rating scale for touch sensitivity) were used. Pain status during tooth brushing, pain during consumption of hot/cold/sweet/sour foods and beverages, pain during breathing (present/absent), gingival irritation, taste changes, post-eruptive breakdown, caries, spontaneous pain, mucosal swelling/fistula tract, mobility, and percussion/palpation sensitivity were evaluated. All sensitivity assessments were performed blindly by a researcher who did not know the baseline scores or the treatment administered. Statistical analysis was performed using SPSS 27.0 software (IBM Corp., Chicago, IL, USA) and the level of significance was set at p<0.05. The assumption of normal distribution was checked using the Shapiro-Wilk test. The Kruskal-Wallis test was used to compare three or more independent groups that did not have a normal distribution. The Friedman test was performed to examine the difference between three dependent groups where the normality assumption was not met. Post Hoc Adjusted Bonferroni tests were performed to determine the group or groups causing the difference. To test the relationship between categorical variables, the Pearson chi-square test was applied when the sample size assumption (expected value >5) was met, and Fisher's exact chi-square test was applied when the sample size assumption was not met.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Proshield 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.

Other names: Riva Star

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.

Other names: Riva Star Aqua

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.

Other names: Gluma Desensitizer

Primary outcomes

  1. Schiff Cold Air Sensitivity Scale for air sensitivity

    Time frame: 6 months

    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.

  2. Wong-Baker Pain Rating Scale for tactile sensitivity

    Time frame: 6 months

    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).

Secondary outcomes

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

    Time frame: 6 months

    Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. Pain status during tooth brushing, pain during consumption of hot/cold/sweet/sour foods and beverages, pain during breathing (present/absent), gingival irritation, taste changes, post-eruptive breakdown, caries, spontaneous pain, mucosal swelling/fistula tract, mobility, and percussion/palpation sensitivity were evaluated (present/absent).

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Evaluation of the Effectiveness of Various Desensitizing Treatment Protocols in Permanent Teeth Affected by Molar Incisor Hypomineralization

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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