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

NCT05945381 | Unknown

• 1 other identifier: BB 047/23
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersensitive; Molar Incisor Hypomineralization; Pit and Fissure Sealants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• child acceptance of procedure

  15 minutes

• hypersensitivity: assessment of the child

  15 minutes

• durability

  3 months

Study Arms (1)

GIC on MIH

EXPERIMENTAL

see below

Combination Product: GIC on MIH

Interventions

GIC on MIH COMBINATION_PRODUCT

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.

GIC on MIH

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Department of Preventive and Pediatric Dentistry, University of Greifswald

Greifswald, D-17457, Germany

RECRUITING

MeSH Terms

Conditions

Hypersensitivity; Molar Hypomineralization; Van der Woude syndrome

Condition Hierarchy (Ancestors)

Immune System Diseases; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christian H Splieth, Prof.

  Dep. preventive & pediatric dentistry, University of Greifswald

  STUDY DIRECTOR

Central Study Contacts

Karim Ramiar, MSc

CONTACT

+49 3834 867136; karim.ramiar@stud.uni-greifswald.de

Julian Schmoeckel, Dr.

CONTACT

+49 3834 867136; julian.schmoeckel@uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 14, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)