Evaluation of the Effectiveness of Various Desensitizing Treatment Protocols

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2025-05-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Molar Incisor Hypomineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

four intervention groups, randomized, single-blind clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

All sensitivity assessments were performed blindly by a researcher who did not know the baseline scores or the treatment administered.

Study Groups

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5% Sodium Fluoride Varnish

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.

Group Type ACTIVE_COMPARATOR

Sodium Fluoride Varnish (5%)

Intervention Type 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.

Silver Diamine Fluoride

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.

Group Type ACTIVE_COMPARATOR

Silver diamine fluoride- potassium iodide

Intervention Type 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.

Aqueous Silver Fluoride

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.

Group Type ACTIVE_COMPARATOR

Aqueous Silver Fluoride

Intervention Type 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.

Hydroxyethyl Methacrylate and Glutaraldehyde (Gluma)

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.

Group Type ACTIVE_COMPARATOR

Hydroxyethyl Methacrylate and Glutaraldehyde

Intervention Type 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.

Interventions

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Sodium Fluoride Varnish (5%)

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.

Intervention Type DEVICE

Silver diamine fluoride- potassium iodide

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.

Intervention Type DEVICE

Aqueous Silver Fluoride

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.

Intervention Type DEVICE

Hydroxyethyl Methacrylate and Glutaraldehyde

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.

Intervention Type DEVICE

Other Intervention Names

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Proshield Varnish Riva Star Riva Star Aqua Gluma Desensitizer

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No