CAD-CAM or Adhesive Approaches for MIH Treatment

NCT06456619 | Completed DMC

• 1 other identifier: D-KA19/04
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: This randomized controlled clinical study aimed to compare direct composite resin restorations and Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) supported inlay or onlay restorations in young permanent molar teeth with hypomineralization. The main questions aim to answer are:

• The clinical success rate of CAD-CAM supported restorations
• The highest clinical success rate for restoring hypomineralized teeth. Materials and method: Children aged 6-14 years old without any systemic conditions with 32 first and second hypomineralized permanent molar teeth were included in the study. Patients were randomly distributed into 2 groups as direct composite resin restorations and CAD-CAM supported inlay or onlay restorations. All restored teeth were evaluated clinically and radiographically for 24-months. Statistical significance was accepted as p\<0.05.

Conditions

Molar Hypomineralization; Dental Restoration Failure of Marginal Integrity

Keywords

Molar incisor hypomineralization; CAD-CAM supported restoration; Composite resin restoration

Outcome Measures

Primary Outcomes (11)

• Clinical evaluation (Modified USPHS criteria- Anatomic form)

  Anatomic form was examined by inspection at 3,6,12,18, and 24 months.

  24 months

• Clinical evaluation (Modified USPHS criteria-Surface roughness)

  Surface roughness was examined by inspection and probing at 3,6,12,18, and 24 months.

  24 months

• Clinical evaluation (Modified USPHS criteria-Marginal adaptation)

  Marginal adaptation was examined by inspection and probing at 3,6,12,18, and 24 months.

  24 months

• Clinical evaluation (Modified USPHS criteria-Marginal discoloration)

  Marginal discoloration was examined by inspection at 3,6,12,18, and 24 months.

  24 months

• Clinical evaluation (Modified USPHS criteria-Retention)

  Retention was examined by inspection and probing at 3,6,12,18, and 24 months.

  24 months

• Clinical evaluation (Modified USPHS criteria-Color stability)

  Color stability was examined by inspection at 3,6,12,18, and 24 months.

  24 months

• Clinical evaluation (Modified USPHS criteria-Secondary caries)

  Secondary caries was examined by inspection and probing at 3,6,12,18, and 24 months.

  24 months

• Clinical evaluation (Modified USPHS criteria-Proximal contact)

  Proximal contact was examined by inspection and probing at 3,6,12,18, and 24 months.

  24 months

• Radiographical evaluation (Lamina dura)

  Lamina dura continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.

  24 months

• Radiographical evaluation (Change in inter-root trabeculation continuity)

  Change in inter-root trabeculation continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.

  24 months

• Radiographical evaluation (Radiolucent area development)

  Radiolucent area development in the inter-root area was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.

  24 months

Study Arms (2)

Composite resin (Filtek Z250, 3M ESPE)

ACTIVE COMPARATOR

A pretreatment protocol including sodium hypochlorite and ortho-phosphoric acid was applied to the tooth surface. Then, the tooth was restored with a composite resin material (Filtek Z250, 3M ESPE). This protocol is a clinically approved way for restoring hypomineralized teeth.

Other: Tooth restoration

CAD-CAM supported (Cerasmart, GC Dental)

EXPERIMENTAL

The preparation was completed by making bevels on the enamel surfaces. Then, an intraoral impression was taken to sent to the laboratory for manufacturing CAD-CAM-supported restoration with a nanohybrid ceramic material (Cerasmart, GC Dental). CAD-CAM supported restorations can be done by using a lot of restorative blocks by milling them. In this study, we preferred using resin-based blocks (Cerasmart, GC Dental) to compare with the control group.

Other: Tooth restoration

Interventions

Tooth restoration OTHER

Comparison of composite resin and CAD-CAM supported restorations for hypomineralized molar teeth in children

CAD-CAM supported (Cerasmart, GC Dental); Composite resin (Filtek Z250, 3M ESPE)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients with first and second permanent molar teeth that have loss of more than one surface due to hypomineralization and seen with white, brown, or yellow opacities on anterior permanent teeth
• Patients without any systemic, physical, physiological, or allergic conditions

You may not qualify if:

• Patients who had symptoms during the follow-up periods
• Patients who did not attend follow-up appointments

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Başkent University

Ankara, Cankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

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

• Didem Sakaryalı Uyar, PhD MD, DDS

  Başkent Universiry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational clinical trial

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: June 13, 2024
• Study Start: January 15, 2020
• Primary Completion: September 15, 2023
• Study Completion: February 15, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)