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NCT Number: NCT06750068

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

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.

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

3D printed space maintainer

Other

Digitally fabricated #d printed space maintainer

Conventional space maintainer

Other

Stainless steel space maintains

Primary outcomes

  1. Survival rate

    Time frame: 1 year

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

Secondary outcomes

  1. Gingival health of the abutment

    Time frame: 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

  2. Plaque accumulation on the abutment tooth

    Time frame: 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

  3. Patients' satisfaction about the impression technique

    Time frame: Immediately after the im- pression/scanning

    Five- question survey

    • "Was the impression easy and fun?"
    • "Did you have nausea during impression?"
    • "Did you feel any discomfort during the impression (taste, odor, foreign body)?"
    • "Did the impression take a short time?"
    • "Would you like to have this impression experience again?"

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Alaa Abdelaziz Elsayed, Assistant lecturer

CONTACT

[email protected]

+201090802757

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Digitally Fabricated 3D-printed Band and Loop Space Maintainers Versus Conventional Band and Loop Space Maintainer : a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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