CAD-CAM or Adhesive Approaches for MIH Treatment
NCT Number: NCT06456619
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Molar Hypomineralization|Dental Restoration Failure of Marginal Integrity
Interventions: OTHER: Tooth restoration
Sponsor: Baskent University
Sex: ALL
Age: CHILD
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2020-01-15
Completion Date: 2024-02-15
Locations: Başkent University, Ankara, Cankaya, 06490, Turkey

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.

Primary Outcome Measures: 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