Dental Caries
Conditions
Keywords
Dental caries, 3D-Printed Resin Crowns, Primary Molars, Pulpotomy, Stainless Steel Crowns, crown retention, Gingival Health
Brief summary
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.
Detailed description
primary mandibular molars will be randomly assigned to receive either 3D-printed resin-based crowns or stainless steel crowns. Following pulp therapy and crown placement, participants will attend follow-up visits over a 12-month period. Clinical evaluation will be performed to assess gingival health, plaque accumulation, crown retention, and child and parent satisfaction, in order to determine whether 3D-printed resin-based crowns can be an effective esthetic alternative to stainless steel crowns.
Interventions
DEVICE3D printed resin based crowns
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).
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Statistician
Intervention model description
Participants will be randomly assigned to one of two parallel groups. One group will receive 3D-printed resin-based crowns, while the other group will receive stainless steel crowns following pulpotomy of primary mandibular molars.
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival index | 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque accumulation | 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. |
| Child and parent satisfaction | 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. |
| Crown retention | 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 |
Countries
Egypt
Contacts
CONTACTNariman Osama, BDS
STUDY_CHAIRSherine Badr, PHD
Cairo University
PRINCIPAL_INVESTIGATORNariman Osama, BDS
Cairo University
STUDY_DIRECTORHanna Abdel Moneim, PHD
Cairo University
Outcome results
None listed