Caries Active
Conditions
Keywords
MTA, bioceramic putty, 3D printed resin crowns, stainless steel crowns
Brief summary
children aged 5 to 7 years with deep carious second primary molars that require vital pulp therapy will be treated using either MTA or bioceramic putty, then will be fully covered using either stainless steel crowns or 3D printed resin crowns.
Detailed description
removal of caries from second primary molars reaching the pulp, pulpotomy will be done by controlling the bleeding after that pulp chamber will be covered with either MTA or endosequence bioceramic putty. resin modified glass ionomer will be placed, crown preparation will be done to receive full coverage either stainless steel crowns or 3D printed resin crowns
Interventions
PROCEDUREEndo-sequence bioceramic putty pulpotomy
* Profound local anesthesia and rubber dam isolation will be applied. * Carious tissue will be completely removed using diamond burs until pulp exposure and deroofing. * Coronal pulp will be removed with a sharp excavator. * Hemostasis will be achieved with a saline-moistened cotton pellet for 5 minutes. * Bioceramic putty applied directly from the manufacturer's syringe, then adapted gently with a moist cotton pellet.
PROCEDUREBio MTA+ pulpotomy
* Profound local anesthesia and rubber dam isolation will be applied. * Carious tissue will be completely removed using diamond burs until pulp exposure and deroofing. * Coronal pulp will be removed with a sharp excavator. * Hemostasis will be achieved with a saline-moistened cotton pellet for 5 minutes. * The MTA powder will be mixed with the liquid to a putty consistency and applied with an amalgam carrier.
DEVICEStainless Steel Crowns (SSCs)
* Occlusal reduction of 1.0-1.5 mm using a flame-shaped diamond bur. * Interproximal slicing to enable passive crown placement. * Crown size selection based on best fit. * Cementation using RMGIC. * Excess cement will be removed.
DEVICE3D-Printed Resin Crowns
* Tooth preparation: 1 mm axial reduction with a chamfer finish line using tapered diamond stone with round end (Mani TR-12) for buccal, lingual, mesial, and distal walls. * One and half - 2 mm occlusal reduction. * Digital impressions using IOS scanning, including occlusion and antagonist. * 3D printed resin crowns will be designed using the Exocad software (Exocad Rigeka 3.1) to have a uniform thickness on all surfaces (average 1 mm), including occlusal, buccal, lingual, and proximal surfaces. After reviewing each design, it will be exported as a high-resolution STL file (standard tessellation language) to be outsourced and 3D printed. * BEGO DLP printer will be utilized to print the crowns using VarseoSmile Trinique resin via digital light processing (DLP) technique. * After printing, the platform will be removed from the 3D printer and placed on a paper towel with the printed crowns facing upward. * The printed crowns will be separated from the platform and rinsed tw
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Children aged from 5 to 7 years. 2. Medically healthy children (ASA I) (Appendix I) 3. Positive or definitely positive behavior (Frankl's rating scale scores III or IV) (Appendix II) 4. Parents/legal guardians who provide written informed consent Tooth inclusion criteria(8, 14, 31) 1. Deep carious second primary molars with: 1. Vital pulp confirmed by absence of clinical and/or radiographic signs of necorosis or infection. 2. Signs of reversible pulpitis. 10 2. Require full coverage restorations 3. Cooperative children (Frankl 3 or 4 behavior rating scale)
Exclusion criteria
* History of spontaneous pain. 2. Tooth mobility. 3. Excessive bleeding from radicular stumps after coronal pulp amputation. 4. Radiographic evidence of pathological root resorption, inter-radicular bone loss, periapical pathology, or canal calcifications. 5. Previous dental treatment of the involved molar. 6. Children with special healthcare needs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| crown evaluation at 12 months using Modified United States Public Health Service | at 12 months | Resistance to dislodgment Alpha: Snap-fit retention Bravo: Partial retention Charlie: No retention Crown - high in occlusion Alpha: Ideal, with the crown being in harmony with occlusion. Bravo: Clinically acceptable, with the crown occluding slightly high or low in occlusion. Charlie: Clinically unacceptable, with the crown needing to be replaced. Retention of crown after cementation Alpha: Intact Bravo: Chipped/loss of material Charlie: Complete loss of crown Occlusal wear of crown Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure. Charlie: Wear of occlusal surface with tooth surface exposure. Wear of opposing crown or tooth Alpha: Clinically ideal, with no evidence of wear. Bravo: Clinically acceptable, with mild wear of the opposing tooth. Charlie: Clinically unacceptable, with severe wear of the opposing tooth. Marginal integrity and discoloration Alpha: Clinically ideal, with no evidence of gap along the gingival crown margin. Bravo: C |
| clinical success of pulpotomy at 12 months | clinical success at 12 months | Absence of pain, sensitivity to percussion, swelling, or fistula. |
| radiographic success of pulpotomy at 1 week | radiographic success at 1 week | No periodontal ligament space widening, resorption, or periapical/furcal radiolucency. |
| radiographic success of pulpotomy at 6 months | radiographic success at 6 months | No periodontal ligament space widening, resorption, or periapical/furcal radiolucency. |
| radiographic success of pulpotomy at 12 months | radiographic success at 12 months | No periodontal ligament space widening, resorption, or periapical/furcal radiolucency. |
| Crown evaluation at 6 months using Modified United States Public Health Service | at 6 months | Resistance to dislodgment Alpha: Snap-fit retention Bravo: Partial retention Charlie: No retention Crown - high in occlusion Alpha: Ideal, with the crown being in harmony with occlusion. Bravo: Clinically acceptable, with the crown occluding slightly high or low in occlusion. Charlie: Clinically unacceptable, with the crown needing to be replaced. Retention of crown after cementation Alpha: Intact Bravo: Chipped/loss of material Charlie: Complete loss of crown Occlusal wear of crown Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure. Charlie: Wear of occlusal surface with tooth surface exposure. Wear of opposing crown or tooth Alpha: Clinically ideal, with no evidence of wear. Bravo: Clinically acceptable, with mild wear of the opposing tooth. Charlie: Clinically unacceptable, with severe wear of the opposing tooth. Marginal integrity and discoloration Alpha: Clinically ideal, with no evidence of gap along the gingival crown margin. Bravo: C |
| clinical success of pulpotomy at 1 week | clinical success at 1 week | Clinical success: Absence of pain, sensitivity to percussion, swelling, or fistula. |
| clinical success of pulpotomy at 6 months | clinical success at 6 months | Absence of pain, sensitivity to percussion, swelling, or fistula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental satisfaction Assessed after 1 week using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction | parental satisfaction after 1 week | 1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied |
| parental satisfaction assessed after 6 months using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction | parental satisfaction after 6 months | 1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied |
| parental satisfaction assessed after 12 months using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction | parental satisfaction after 12 months | 1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied |
| Child satisfaction Measured immediately post-cementation using a Smiley Face Likert scale in child-friendly language. | immediately after crown cementation | Child Satisfaction (Smiley Face Likert Scale) awful not very good good really good fantastic |
| Parental satisfaction Assessed immediately after treatment using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction | immediately after treatment | 1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied |
Countries
Egypt
Contacts
Primary Contactyousr nader pediatric dentist specialist, doctorate
Outcome results
None listed