CAD-CAM or Adhesive Approaches for MIH Treatment
- Conditions
- Molar HypomineralizationDental Restoration Failure of Marginal Integrity
- Interventions
- Other: Tooth restoration
- Registration Number
- NCT06456619
- Lead Sponsor
- Baskent University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- Patients who had symptoms during the follow-up periods
- Patients who did not attend follow-up appointments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAD-CAM supported (Cerasmart, GC Dental) Tooth restoration 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. Composite resin (Filtek Z250, 3M ESPE) Tooth restoration 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.
- Primary Outcome Measures
Name Time Method Clinical evaluation (Modified USPHS criteria-Surface roughness) 24 months Surface roughness was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Secondary caries) 24 months Secondary caries was examined by inspection and probing at 3,6,12,18, and 24 months.
Radiographical evaluation (Radiolucent area development) 24 months Radiolucent area development in the inter-root area was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Clinical evaluation (Modified USPHS criteria- Anatomic form) 24 months Anatomic form was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Marginal discoloration) 24 months Marginal discoloration was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Retention) 24 months Retention was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Marginal adaptation) 24 months Marginal adaptation was examined by inspection and probing at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Color stability) 24 months Color stability was examined by inspection at 3,6,12,18, and 24 months.
Clinical evaluation (Modified USPHS criteria-Proximal contact) 24 months Proximal contact was examined by inspection and probing at 3,6,12,18, and 24 months.
Radiographical evaluation (Lamina dura) 24 months Lamina dura continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
Radiographical evaluation (Change in inter-root trabeculation continuity) 24 months Change in inter-root trabeculation continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Başkent University
🇹🇷Ankara, Cankaya, Turkey