Clinical trial NCT06456619: CAD-CAM or Adhesive Approaches for MIH Treatment
Official title: Clinical and Radiographic Evaluation of Composite Resin Restorations and Computer-Aided Restorations in Young Permanent Molar Teeth With Molar Incisor Hypomineralization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molar Hypomineralization
Dental Restoration Failure of Marginal Integrity
Keywords: Molar incisor hypomineralization
CAD-CAM supported restoration
Composite resin restoration
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Observational clinical trial
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical evaluation (Modified USPHS criteria- Anatomic form)
timeFrame: 24 months
measure: Clinical evaluation (Modified USPHS criteria-Surface roughness)
timeFrame: 24 months
measure: Clinical evaluation (Modified USPHS criteria-Marginal adaptation)
timeFrame: 24 months
measure: Clinical evaluation (Modified USPHS criteria-Marginal discoloration)
timeFrame: 24 months
measure: Clinical evaluation (Modified USPHS criteria-Retention)
timeFrame: 24 months
measure: Clinical evaluation (Modified USPHS criteria-Color stability)
timeFrame: 24 months
measure: Clinical evaluation (Modified USPHS criteria-Secondary caries)
timeFrame: 24 months
measure: Clinical evaluation (Modified USPHS criteria-Proximal contact)
timeFrame: 24 months
measure: Radiographical evaluation (Lamina dura)
timeFrame: 24 months
measure: Radiographical evaluation (Change in inter-root trabeculation continuity)
timeFrame: 24 months
measure: Radiographical evaluation (Radiolucent area development)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Başkent University
state: Cankaya
Study officials:
affiliation: Başkent Universiry
name: Didem Sakaryalı Uyar, PhD MD, DDS
role: PRINCIPAL_INVESTIGATOR
References: