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

N/ANot Yet RecruitingNCT06750068

Cairo University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Tooth Loss

Interventions

3D printed space maintainerOTHER

Digitally fabricated #d printed space maintainer

Conventional space maintainerOTHER

Stainless steel space maintains

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Survival rate

Decementation, debonding, solder breakage, loop breakage, band breakage, and abutment tooth fracture will be evaluated clinically for both space maintainers

Time frame: 1 year

Secondary Outcomes

Gingival health of the abutment

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

Time frame: 0,6,12 months

Plaque accumulation on the abutment tooth

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

Time frame: 0,6,12 months

Patients' satisfaction about the impression technique

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?"

Time frame: Immediately after the im- pression/scanning

Central Contacts

Aya Alaa Abdelaziz Elsayed, Assistant lecturer

CONTACT

+201090802757 aya.alaa@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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