Effect of Glass-Ionomer Sealing Technique on Hypersensitive Teeth With Molar Incisor Hypomineralisation (MIH_GIC)

Evaluation of Efficiency, Acceptance and the Durability of Glass-Ionomer Sealing Technique on Hypersensitive MIH (Molar Incisor Hypomineralisation) Teeth With and Without Enamel Breakdown - a Cohort Study

This single armed cohort study is aimed to assess the acceptance, durability and efficiency of glass-Ionomer sealing technique on hypersensitive MIH molars (TNI-3 & 4a/b/c) clinically shortly (15 minutes) after the application and after a time period of 3 months.

Study Overview

• Status: Recruiting
• Conditions: Molar Incisor Hypomineralization; Hypersensitive; Pit and Fissure Sealants
• Intervention / Treatment: Combination product: GIC on MIH

Detailed Description

The main assumption of the study is that sealing of hypersensitive MIH molars (TNI-3 & 4a/b/c) using glass-ionomer cement reduces the degree of hypersensitivity after direct placement and within a period of time. Moreover, glass-ionomer sealing has a good durability in hypomineralized teeth and is known to be acceptable due to it's easy and fast application.

The aim of this study is to assess the change in the degree of hypersensitivity in the sealed MIH (molar incisor hypomineralisation) tooth / teeth (IonoStar Plus, VOCO-Germany) in the same visit (15 Minutes after the application) and in the 3 months' recall-visit according to Schiff Cold Air Sensitivity (SCASS) Test and the self-report of the patient using Wong- Baker Faces Rating Scale.

This single armed cohort study will be undertaken at the Department of Preventive and Pediatric Dentistry at the University of Greifswald from approximately May 2023 to Autumn 2024. After assessment of eligibility and informed consent for participation in the study, hypersensitivity of the affected MIH permanent molars will be assessed using air blast before the treatment using SCASS (Schiff cold air sensitivity Scale) and VAS (Visual analogue scale) in order to record the degree of sensitivity and pain perception of the child. After initial assessment, the affected teeth are prepared to receive a Glass- Ionomer cement fissure sealant (IonoStar Plus, VOCO GmbH Germany).

The level of tooth sensitivity will be assessed again 15 minutes after the treatment and in the regular 3 months follow up via air blast test (Schiff Cold Air Sensitivity Scale), the pain perception is being recorded with VAS (Visual analogue scale) by an independent observer, dental assistant and the operating dentist. The independent observer will assess the cooperation and behaviour of the child throughout the treatment using FBRS (Frankl behavioural rating scale) and FIS (Facial image scale).

The durability of the fissure sealant will be assessed using the modified USPHS criteria in the 3 months' follow-up. After the dental visit, the participating child the accompanying parent or caregiver, the dental operator receives a short questionnaire to be filled out.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karim Ramiar, MSc; Phone Number: +49 3834 867136; Email: karim.ramiar@stud.uni-greifswald.de
• Study Contact Backup: Name: Julian Schmoeckel, Dr.; Phone Number: +49 3834 867136; Email: julian.schmoeckel@uni-greifswald.de

Study Locations

• Germany
  • Greifswald, Germany, D-17457
    • Recruiting
    • Department of Preventive and Pediatric Dentistry, University of Greifswald
    • Contact: Christian Splieth, Prof. Dr.; Phone Number: 0049 3834 867101; Email: splieth@uni-greifswald.de
    • Contact: Julian Schmoeckel, Dr.; Phone Number: 0049 3834 867167; Email: juilan.schmoeckel@uni-greifswald.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Self-reported hypersensitive MIH molar (MIH-TNI 3 & 4a/b/c).
• Children & adolescents without systematic health diseases.
• No sealing therapy or application of desensitizing agent on the MIH-teeth within 1 month before participation in the study.
• Agreement to voluntary participation in the study.

Exclusion Criteria:

• Patients with acute pain/ patients with signs or symptoms to be treated.
• Patients with systemic disease that require special attention during their dental treatment.
• Parents / children who refused to participate in the study. - MIH teeth with signs of irreversible pulpitis.
• Allergy against any ingredients of the material.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GIC on MIH; see below

Combination product: GIC on MIH; Subjects will be seated in a dental chair set-up using standard infection control guidelines. Then the study and its objectives will be explained to the patients and their caregivers. The tooth will be cleaned with a prophylactic paste and brush for complete debris and plaque removal. The tooth will then be dried with a cotton roll, as the patient doesn't tolerate the air-drying (which is the case in SCASS 2 and 3). Moisture control will be kept with cotton roll, the tooth is then sealed with a hard setting glass-ionomer cement (IonoStar Plus, VOCO, Germany) followed by an application of a surface coat (Easy Glaze, VOCO, Germany) for moisture and dehydration protection after sealant application. The distributed questionnaire will include questions regarding the attitude of the child's caregiver to the idea and their estimation of the child's fair regarding dental visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypersensitivity (mid-term)	Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) in the 3 months' recall-visit according to Schiff Cold Air Sensitivity (SCASS) Test. (scale: 0;1;2;3; max hypersensitivity: 3; no hypersensitivity 0)	3 months
Hypersensitivity (short-term)	Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) after 15 minutes according to Schiff Cold Air Sensitivity (SCASS) Test. (scale: 0;1;2;3; max hypersensitivity: 3; no hypersensitivity 0)	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
child acceptance of procedure	- Assessment of acceptance of the child toward the procedure using Likert Scale (scale: 1-5)	15 minutes
hypersensitivity: assessment of the child	Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) regarding self-report of the patient using Wong- Baker Faces Rating Scale. (0-10; 0=no hurt; 10=hurts worst)	15 minutes
durability	Evaluation of durability of the sealant material on the MIH-teeth using modified USPHS assessment's criteria (in 3 months' recall). Scale Alpha: No loss of sealing material Bravo: Partial loss of sealing material Charlie: Loss of restorative material	3 months

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Study Director: Christian H Splieth, Prof., Dep. preventive & pediatric dentistry, University of Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Hypersensitivity; Dental Enamel Hypoplasia; Molar Hypomineralization
• Other Study ID Numbers: BB 047/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No