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3D-Printed Resin Crowns vs Stainless Steel Crowns in Pulpotomized Primary Molars. (3DRSCVSSSC)
Clinical Evaluation of 3D Printed Resin Based Crowns Versus Stainless Steel Crowns in Pulpotomized Primary Mandibular Molars : A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn whether 3D-printed resin-based crowns are an effective alternative to stainless steel crowns for restoring pulpotomized primary mandibular molars in children. The main questions it aims to answer are:
Do 3D-printed resin-based crowns provide better gingival health than stainless steel crowns? Are there differences in plaque accumulation, crown retention, and child and parent satisfaction between the two crown types?
Participants will:
Receive either a 3D-printed resin-based crown or a stainless steel crown after pulpotomy.
Attend follow-up visits for clinical evaluation over 12 months.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Nariman Osama, BDS
- Telefoonnummer: 01010381531
- E-mail: Nareman.osama@dentistry.cu.edu.eg
Studie Locaties
-
-
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Cairo, Egypte
- Faculty of Dentistry
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Children aged 4 to 8 years. Cooperative children who are able to accept dental treatment. Teeth diagnosed with reversible pulpitis. Children in good general health with no systemic conditions affecting oral health.
Parents/guardians willing to provide written informed consent and attend follow-up visits.
Exclusion Criteria:
Teeth deemed non-restorable (e.g., gross carious destruction or fractures beyond restoration).
Parents/guardians unwilling to participate in the study or provide informed consent.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 3D printed resin crowns
Children will receive indirect restorations using 3D-printed resin crowns on primary molars affected by reversible pulpitis
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1-Select an appropriately sized resin-based prefabricated crown based on the mesio-distal width of the tooth.
2-Perform occlusal reduction of approximately 1.5-2.0
mm following the natural occlusal anatomy.
3-Reduce buccal and lingual cusps, central groove, and marginal ridges to achieve adequate occlusal clearance.
4-Perform proximal reduction using a tapered fissure or diamond bur to eliminate mesial and distal contacts by approximately 1.0 mm.
5-Avoid creating ledges or damaging adjacent teeth during proximal reduction.
6-Slightly reduce buccal and lingual surfaces to eliminate undercuts and facilitate crown seating.
7-Round and smooth all sharp line angles and points of the preparation.
8-In cases with adjacent teeth, perform additional interproximal reduction if required for proper seating.9-Try-in the crown intraorally and seat it using firm pressure from lingual to buccal direction.
10-Check marginal adaptation, ensuring slight subgingival extension (approximately 0.5-1.0
mm).
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Actieve vergelijker: Stainless steel crowns
Children will receive stainless steel crowns on primary molars affected by reversible pulpitis
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1-Select an appropriately sized stainless steel crown based on the mesiodistal width of the tooth.
2-Perform minimal occlusal reduction (approximately 1.0-1.5 mm) following the anatomical occlusal contour to create suficient space for crown placement.
3-Lightly reduce proximal contacts to allow crown seating, without creating steps or excessive taper.
4-Perform minimal buccal and lingual reduction only if required to eliminate undercuts and facilitate passive seating.
5-Round sharp line angles and smooth rough surfaces to allow proper adaptation.
5-Verify adequate occlusal clearance and passive path of insertion.
6-Try-in the crown and adjustsize if necessary to ensure proper fit.
7-Trim and contour crown margins to achieve optimal gingival adaptation (if needed).
8-Seat the crown firmly using finger pressure to confirm complete seating.
9-Cement the crown with glass ionomer cement and remove excess cement after initial setting.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Gingival index
Tijdsspanne: baseline, 3 months, 6 months, 9 months, 12 months
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The GI was measured by passing an explorer tip gently within the sulcus mesial, distal, buccal, and lingual surface of each crowned molar. it was scored on a scale of 0 to 3 0= no bleeding
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baseline, 3 months, 6 months, 9 months, 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Plaque accumulation
Tijdsspanne: baseline, 3 months, 6 months, 9 months, 12 months
|
Silness &Löe plaque index 0: no plaque.
1: film at gingival margin.
2: moderate accumulation.
3: abundance of plaque.
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baseline, 3 months, 6 months, 9 months, 12 months
|
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Child and parent satisfaction
Tijdsspanne: Immediately post operative
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Child and parent satisfaction will be assessed using a structured questionnaire based on a Likert scale.
Participants (children and their parents/guardians) will rate their satisfaction with the treatment experience, comfort, aesthetics, and overall acceptance.
Responses will be recorded on a 5-point Likert scale ranging from "very dissatisfied" to "very satisfied."
The scores will be analyzed to compare satisfaction between study groups.
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Immediately post operative
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Crown retention
Tijdsspanne: baseline, 3 months, 6 months, 9 months, 12 months
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Using United States Public Health Service (USPHS) criteria Alpha : intact Bravo : chipped or loss of material Charlie : complete loss of crown
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baseline, 3 months, 6 months, 9 months, 12 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Sherine Badr, PHD, Cairo University
- Hoofdonderzoeker: Nariman Osama, BDS, Cairo University
- Studie directeur: Hanna Abdel Moneim, PHD, Cairo University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FDCU-2026-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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