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NCT Number: NCT06825273

Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer

Primary dentition is the most suitable space maintainer for permanent teeth. However, as infants often lose their primary teeth too soon, using a space maintainer is the most efficient, long-lasting, and economical way to prevent malocclusions and function impairment in the future. Regarding personalized appliances, space maintainers in digital pediatric dentistry have made significant progress. Digital technology decreases the manual manufacturing stages that take a long time and increases the reliability and durability of digital fabrication procedures.

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Key information

Conditions

Space Maintenance Gingival Health

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University, Tanta, Egypt

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • apparently, healthy cooperative children having recent premature loss of lower primary molars
  • the permanent successors of the lost primary molars were not expected to erupt within 6 months
  • Angle's class 1 occlusion with normal primary molar relation
  • Presence of teeth on the mesial and distal side of the edentulous area
  • Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
  • Radiographically, presence of permanent successors.
  • parents and children were accepting the new treatment modality.

Exclusion criteria

  • children exhibited poor oral hygiene, para-functional oral habits, severe crowding, space loss, and abnormal occlusion
  • Extraction of primary molars exceeding three months.
  • Radiographically, absence of permanent successor.
  • uncooperative children

Treatment and study plan

space maintainer

Other

3-D printed partial denture space maintainer will designed for each child patient who has premature loss of primary teeth after doing intraoral scanning

Primary outcomes

  1. clinical evaluation

    Time frame: three months

    the clinical performance of the partial denture space maintainers in the recall visits will be to assess: the Fracture of the space maintainer, and Lost or missing

  2. gingival health

    Time frame: three months

    using a Williams periodontal probe, gingival index will be evaluated according to the following criteria:

    • 0: Healthy gingiva.
    • 1: There is mild inflammation, discoloration and edema, no bleeding on probing.
    • 2: Moderate inflammation, marked redness, edema, and bleeding on probing.
    • 3: Severe inflammation, prominent redness and edema, ulceration, spontaneous bleeding tendency.

  3. plaque index

    Time frame: three months

    using a Williams periodontal probe, the plaque index will be assessed using the Silness-Loe plaque index: 0: Absence of microbial plaque, 1: Thin film of microbial plaque along the free gingival margin, 2: Moderate accumulation with plaque in the sulcus, 3: Large amount of plaque in the sulcus or pocket along the free gingiva margin.

Study contacts

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

shaimaa eldesouky, assistant professor

CONTACT

[email protected]

+201008994242

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer and Its Impact on Children's Oral Health Status: A Randomized Controlled Clinical Crossover Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2025
Registry last updated
Apr 17, 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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