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

Primary Purpose

Hypersensitive, Molar Incisor Hypomineralization, Pit and Fissure Sealants

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
GIC on MIH
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitive

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Preventive and Pediatric Dentistry, University of GreifswaldRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GIC on MIH

Arm Description

see below

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

child acceptance of procedure
- Assessment of acceptance of the child toward the procedure using Likert Scale (scale: 1-5)
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)
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

Full Information

First Posted
June 6, 2023
Last Updated
July 13, 2023
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT05945381
Brief Title
Effect of Glass-Ionomer Sealing Technique on Hypersensitive Teeth With Molar Incisor Hypomineralisation
Acronym
MIH_GIC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitive, Molar Incisor Hypomineralization, Pit and Fissure Sealants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GIC on MIH
Arm Type
Experimental
Arm Description
see below
Intervention Type
Combination Product
Intervention Name(s)
GIC on MIH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hypersensitivity (mid-term)
Description
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)
Time Frame
3 months
Title
Hypersensitivity (short-term)
Description
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)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
child acceptance of procedure
Description
- Assessment of acceptance of the child toward the procedure using Likert Scale (scale: 1-5)
Time Frame
15 minutes
Title
hypersensitivity: assessment of the child
Description
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)
Time Frame
15 minutes
Title
durability
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim Ramiar, MSc
Phone
+49 3834 867136
Email
karim.ramiar@stud.uni-greifswald.de
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Schmoeckel, Dr.
Phone
+49 3834 867136
Email
julian.schmoeckel@uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian H Splieth, Prof.
Organizational Affiliation
Dep. preventive & pediatric dentistry, University of Greifswald
Official's Role
Study Director
Facility Information:
Facility Name
Department of Preventive and Pediatric Dentistry, University of Greifswald
City
Greifswald
ZIP/Postal Code
D-17457
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Splieth, Prof. Dr.
Phone
0049 3834 867101
Email
splieth@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Julian Schmoeckel, Dr.
Phone
0049 3834 867167
Email
juilan.schmoeckel@uni-greifswald.de

12. IPD Sharing Statement

Plan to Share IPD
No

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

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