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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endo-sequence bioceramic putty pulpotomy | Experimental |
| |
| Bio MTA+ | Active Comparator |
| |
| 3D-printed ceramic-filled hybrid resin crowns | Experimental |
| |
| Stainless steel crowns | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endo-sequence bioceramic putty pulpotomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical success of pulpotomy at 1 week | Clinical success: Absence of pain, sensitivity to percussion, swelling, or fistula. | clinical success at 1 week |
| clinical success of pulpotomy at 6 months | Absence of pain, sensitivity to percussion, swelling, or fistula. | clinical success at 6 months |
| clinical success of pulpotomy at 12 months | Absence of pain, sensitivity to percussion, swelling, or fistula. | clinical success at 12 months |
| radiographic success of pulpotomy at 1 week | No periodontal ligament space widening, resorption, or periapical/furcal radiolucency. | radiographic success at 1 week |
| radiographic success of pulpotomy at 6 months | No periodontal ligament space widening, resorption, or periapical/furcal radiolucency. | radiographic success at 6 months |
| radiographic success of pulpotomy at 12 months | No periodontal ligament space widening, resorption, or periapical/furcal radiolucency. | radiographic success at 12 months |
| Crown evaluation at 6 months using Modified United States Public Health Service | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parental satisfaction Assessed immediately after treatment using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction | 1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied | immediately after treatment |
| Parental satisfaction Assessed after 1 week using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction |
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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)
Deep carious second primary molars with:
Require full coverage restorations
Cooperative children (Frankl 3 or 4 behavior rating scale)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yousr nader pediatric dentist specialist, doctorate | Contact | yousr.nader@gmail.com | yousr.nader@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University, Egypt | Recruiting | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Academy of Pediatric Dentistry. Pulp therapy for primary and immature permanent teeth Chicago (IL): American Academy of Pediatric Dentistry; 2023. 2. Abdelwahab DH KN, Badran AS, Darwish D, Abd El Geleel OM. Oneyear radiographic and clinical performance of bioactive materials in primary molar pulpotomy: A randomized controlled trial. J Dent 2024;143:104864. 3. Wang Z. Bioceramic materials in endodontics. Endod Topics 2015;32:3- 30. 4. Mahgoub N, Alqadasi B, Aldhorae K, Assiry A, Altawili ZM, Tao H. Comparison between iRoot BP Plus (EndoSequence Root Repair Material) and Mineral Trioxide Aggregate as Pulp-capping Agents: A Systematic Review. J Int Soc Prev Community Dent 2019;9:542-52. 5. Moazzami F, Sahebi S, Shirzadi S, Azadeh N. Comparative in vitro Assessment of Tooth Color Change under the Influence of Nano Fast Cement and MTA. J Dent (Shiraz) 2021;22:48-52. 6. Ayoub KM, Nagy MM, Aly RM, El Deen GN, El-Batouty K. Effect of Bio MTA plus & ProRoot MTA pulp capping materials on the regenerative properties of human dental pulp stem cells. Sci Rep 2025;15:4749. 7. Voicu G, Didilescu AC, Stoian AB, Dumitriu C, Greabu M, Andrei M. Mineralogical and Microstructural Characteristics of Two Dental Pulp Capping Materials. Materials (Basel) 2019;12:1772. 25 8. Kiranmayi T, Vemagiri CT, Rayala C, Chandrappa V, Bathula H, Challagulla A. In vivo comparison of bioceramic putty and mineral trioxide aggregate as pulpotomy medicament in primary molars. A 12- month follow-up randomized clinical trial. Dent Res J (Isfahan) 2022;19:84. 9. Alqahtani AS, Alsuhaibani NN, Sulimany AM, Bawazir OA. NeoPUTTY(®) Versus NeoMTA 2(®) as a Pulpotomy Medicament for Primary Molars: A Randomized Clinical Trial. Pediatr Dent 2023;45:240-4. 10. Arvelaiz C, Fernandes A, Graterol V, Gomez K, Gomez-Sosa JF, Caviedes-Bucheli J, et al. In Vitro Comparison of MTA and BC RRMFast Set Putty as Retrograde Filling Materials. Eur Endod J 2022;7:203- 9. 11. Motwani N, Ikhar A, Nikhade P, Chandak M, Rathi |
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|
| Bio MTA+ pulpotomy | Procedure |
|
|
| Stainless Steel Crowns (SSCs) | Device |
|
|
| 3D-Printed Resin Crowns | Device |
|
|
| at 6 months |
| crown evaluation at 12 months using Modified United States Public Health Service | 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 | at 12 months |
1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied |
| parental satisfaction after 1 week |
| parental satisfaction assessed after 6 months using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction | 1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied | parental satisfaction after 6 months |
| parental satisfaction assessed after 12 months using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction | 1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied | parental satisfaction after 12 months |
| Child satisfaction Measured immediately post-cementation using a Smiley Face Likert scale in child-friendly language. | Child Satisfaction (Smiley Face Likert Scale) awful not very good good really good fantastic | immediately after crown cementation |