3D-Printed Resin Crowns vs Stainless Steel Crowns in Pulpotomized Primary Molars.

ConditionDental Caries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D printed resin based crowns

    Device

    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).

  • Prefabricated stainless steel crowns

    Device

    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.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: 3D printed resin crownsExperimental treatment 1 intervention
Group B: Stainless steel crownsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gingival index

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 1. only one bleeding point appearing someseconds after probing 2. bleeding points appearing immediately after probing 3. profuse bleeding appearing immediately after probing spreading towards the marginal gingiva

Time frame
baseline, 3 months, 6 months, 9 months, 12 months

Secondary outcomes

1

Plaque accumulation

Silness \&Löe plaque index 0: no plaque. 1: film at gingival margin. 2: moderate accumulation. 3: abundance of plaque.

Time frame
baseline, 3 months, 6 months, 9 months, 12 months
2

Child and parent satisfaction

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.

Time frame
Immediately post operative
3

Crown retention

Using United States Public Health Service (USPHS) criteria Alpha : intact Bravo : chipped or loss of material Charlie : complete loss of crown

Time frame
baseline, 3 months, 6 months, 9 months, 12 months

Other outcomes

Sponsors and contacts

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