3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorUniversidad Autonoma de Baja California
About this trial
The aim of the study is to compare preformed metal crowns and 3D-printed ceromer crowns in primary molars of 4-9 years old children. The main questions it aims to answer are:
* How does 3D-printed ceromer crowns compare clincally to stainless steel crowns when restoring posterior molars? * What is the level of satisfaction of the patient with both materials? * What is the level of parental satisfaction with both materials?
Study methodology:
This study is a split-mouth clinical trial where participants will receive at least one of each materials in different quadrants of the mouth.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 4 to 9 years with at least 2 primary molars affected by deep occlusoproximal caries.
Teeth may require pulp therapy (pulpotomy or pulpectomy) and be suitable for full-coverage restoration.
Teeth must have an antagonist and be located in opposing hemiarches.
The affected primary molars must be expected to remain in the mouth for at least 12 months.
Disqualifiers
Children with systemic diseases or medical conditions affecting oral health.
Uncooperative behavior (Frankl scale 3 or 4).
Temporomandibular joint disorders or parafunctional habits (e.g., bruxism).
Absence of antagonist or adjacent teeth in the selected quadrants.
Trial design
Design model
Parallel
Treatments tested in this trial
Personalized 3D-printed pediatric ceromer crown
Procedure/SurgeryAfter primary molar crown preparation, digital impression using intraoral scanner (i700, Medit, Seoul, South Korea), crown will be designed with CAD software (CliniCAD, medit, South Korea) and fabricated using a 3D printer, (Sonic mini 4k, Phrozen, Taipei, Taiwan). Crown will be cemented by passive seating using a self-adhesive dual cure cement (Beauticem, shofu, San Marcos, CA, USA)
Prefabricated stainless steel crown group
DeviceStainless steel crown application: After preparation of the tooth, the crown will be filled and cemented with type-1 glass ionomer cement (Ketac Cem easymix, 3M ESPE, Minnesota, USA)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: 3D-printed ceromer crownExperimental treatment 1 intervention
Group B: Stainless steel crownActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Plaque index (PI) (Silness and Loe, 1964)
0- No plaque in the area adjacent to the gingiva 1. There is a thin film on the edge of the gingival margin. (detected with the help of a probe) 2. There is presence of plaque in the gingival pocket and gingival margin at a level that can be determined by eye. There is no plaque in the proximal area. 3. A large amount of plaque layer is observed in the gingival pocket and gingival margin. Interdental area is filled with plaque.
Time frame
12 months2
Gingival Index (GI) (Loe & Silness, 1963)
0- Healthy gingiva, no inflammation 1. Mild inflammation, discoloration and mild edema of the gums, no bleeding on probing. 2. Moderate inflammation, redness and edema in gums, bleeding on probing. 3. Advanced inflammation, redness, edema in gums, spontaneous bleeding is observed.
Time frame
12 months3
International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations
Functional, Biological and Esthetic properties, scored from 1-5 (higher score meaning worse result.
Time frame
12 monthsSecondary outcomes
1
Patient satisfaction
A 5 question satisfaction questionnaire with 5 point lykert scale questions
Time frame
6 months2
Parental satisfaction
A 5 question satisfaction questionnaire with 5 point lykert scale questions
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: