CAD-CAM or Adhesive Approaches for MIH Treatment

Dental Restoration Failure of Marginal Integrity Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Composite Resin Restorations and Computer-Aided Restorations in Young Permanent Molar Teeth With Molar Incisor Hypomineralization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06456619
• Other study ID #: D-KA19/04
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: February 15, 2024

Study information

• Verified date: June 2024
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After randomization and local anesthesia administration, caries removal and preparation were completed under rubber-dam isolation. After preparation, 60 seconds of orthophosphoric acid, 60 seconds of 5% sodium hypochlorite and 30 seconds of orthophosphoric acid steps were applied before bonding agent and composite resin restorations. On the other hand, the preparation was completed by making a bevel on the enamel surfaces and a nanohybrid ceramic material used for the manufacturing CAD-CAM supported inlay or onlay restorations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 15, 2024
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who had symptoms during the follow-up periods

• Patients who did not attend follow-up appointments

Related Conditions & MeSH terms

• Dental Restoration Failure of Marginal Integrity

Intervention

Other:
• Tooth restoration
Comparison of composite resin and CAD-CAM supported restorations for hypomineralized molar teeth in children

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation (Modified USPHS criteria- Anatomic form)	Anatomic form was examined by inspection at 3,6,12,18, and 24 months.	24 months
Primary	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
Primary	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
Primary	Clinical evaluation (Modified USPHS criteria-Marginal discoloration)	Marginal discoloration was examined by inspection at 3,6,12,18, and 24 months.	24 months
Primary	Clinical evaluation (Modified USPHS criteria-Retention)	Retention was examined by inspection and probing at 3,6,12,18, and 24 months.	24 months
Primary	Clinical evaluation (Modified USPHS criteria-Color stability)	Color stability was examined by inspection at 3,6,12,18, and 24 months.	24 months
Primary	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
Primary	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
Primary	Radiographical evaluation (Lamina dura)	Lamina dura continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.	24 months
Primary	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
Primary	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