Evaluation of 3D-printed Space Maintainers Versus Conventional Space Maintainer : a Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Tooth Loss

• Registration Number: NCT06750068
• Lead Sponsor: Cairo University

Brief Summary

This study aims to compare the clinical evaluation and patients' satisfaction of space maintainers produced by digital workflow using the 3D-printing method (3D-SMs) versus conventional band and loop space maintainers (C-SMs) produced by traditional methods.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Study Start: 2025-03-20
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Lower first permanent molar in active state of eruption
• Patient and parent showing cooperation and compliance.
• Medically free children.
• According to space analysis available space is less than or equal to needed space
• Primary molar loss in the last 1 week due to caries, infection, and resorption (to eliminate possible space loss)
• Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines.

Exclusion Criteria

• Children with previous allergies to stainless steel.
• There was less than one year left for the permanent tooth to erupt (to prevent possible abutment toot loss)
• The patient's oral hygiene is not sufficient and has periodontal problems (to accurately assess the periodontal effects)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival rate	1 year	Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers

Secondary Outcome Measures

Name	Time	Method
Gingival health of the abutment	0,6,12 months	Gingival index 0 = normal gingiva; 1 = mild inflammation: slight change in color, slight edema, no bleeding on probing; 2 = moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3 = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding
Plaque accumulation on the abutment tooth	0,6,12 months	Plaque index Score 0: No Plaque Score 1:Thin plaque layer at the gingival margin, only detectable by scraping with a probe Score 2: Moderate layer of plaque along the gingival margin; interdental spaces free, but plaque is visible to the naked eye Score 3:Abundant plaque along the gingival margin; interdental spaces filled with plaque
Patients' satisfaction about the impression technique	Immediately after the im- pression/scanning	Five- question survey; 1. "Was the impression easy and fun?"; 2. "Did you have nausea during impression?"; 3. "Did you feel any discomfort during the impression (taste, odor, foreign body)?"; 4. "Did the impression take a short time?"; 5. "Would you like to have this impression experience again?"