Evaluation of the Effectiveness of Various Desensitizing Treatment Protocols

Hacettepe University

Status: Completed

Conditions: Molar Incisor Hypomineralization

Treatments: Device: Silver diamine fluoride- potassium iodide; Device: Aqueous Silver Fluoride; Device: Hydroxyethyl Methacrylate and Glutaraldehyde; Device: Sodium Fluoride Varnish (5%)

Study type: Interventional

Funder types: Other

Identifiers

NCT07085689

HUDHF-MIH-desensitization

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 7 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 4 patient groups

5% Sodium Fluoride Varnish

Active Comparator group

Description:

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.

Treatment:

Device: Sodium Fluoride Varnish (5%)

Silver Diamine Fluoride

Active Comparator group

Description:

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.

Treatment:

Device: Silver diamine fluoride- potassium iodide

Aqueous Silver Fluoride

Active Comparator group

Description:

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.

Treatment:

Device: Aqueous Silver Fluoride

Hydroxyethyl Methacrylate and Glutaraldehyde (Gluma)

Active Comparator group

Description:

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.

Treatment:

Device: Hydroxyethyl Methacrylate and Glutaraldehyde