- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07648979
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Nariman Osama, BDS
- Telefonnummer: 01010381531
- E-post: Nareman.osama@dentistry.cu.edu.eg
Studieorter
-
-
-
Cairo, Egypten
- Faculty of Dentistry
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 3D printed resin crowns
Children will receive indirect restorations using 3D-printed resin crowns on primary molars affected by reversible pulpitis
|
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).
|
|
Aktiv komparator: Stainless steel crowns
Children will receive stainless steel crowns on primary molars affected by reversible pulpitis
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gingival index
Tidsram: baseline, 3 months, 6 months, 9 months, 12 months
|
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
|
baseline, 3 months, 6 months, 9 months, 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Plaque accumulation
Tidsram: 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.
|
baseline, 3 months, 6 months, 9 months, 12 months
|
|
Child and parent satisfaction
Tidsram: Immediately post operative
|
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
|
|
Crown retention
Tidsram: baseline, 3 months, 6 months, 9 months, 12 months
|
Using United States Public Health Service (USPHS) criteria Alpha : intact Bravo : chipped or loss of material Charlie : complete loss of crown
|
baseline, 3 months, 6 months, 9 months, 12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Sherine Badr, PHD, Cairo University
- Huvudutredare: Nariman Osama, BDS, Cairo University
- Studierektor: Hanna Abdel Moneim, PHD, Cairo University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FDCU-2026-01
Plan för individuella deltagardata (IPD)
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