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Recruiting NCT06825273

Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer

No phase Interventional Space Maintenance Gingival Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: space maintainer, space maintainer.
Who it may be relevant to
Registry conditions: Space Maintenance, Gingival Health. Basic parameters: 7 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Other space maintainer
    3-D printed partial denture space maintainer will designed for each child patient who has premature loss of primary teeth after doing intraoral scanning
  • Other space maintainer
    a conventional impression will be done for a child patient with premature loss of his primary teeth, then a plaster model will gained. A conventional acrylic partial denture will be designed and delivered to the patient.

Primary outcome measures

  • clinical evaluation [Time frame: three months]
  • gingival health [Time frame: three months]
  • plaque index [Time frame: three months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 2 centers
  • pediatric dentistry department, faculty of dentistry, Tanta university — Tanta
  • Tanta University — Tanta

Publications

  • Guo H, Wang Y, Zhao Y, Liu H. Computer-aided design of polyetheretherketone for application to removable pediatric space maintainers. BMC Oral Health. 2020 Jul 10;20(1):201. doi: 10.1186/s12903-020-01184-6. PMID 32650758
  • Dhanotra KG, Bhatia R. Digitainers-Digital Space Maintainers: A Review. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S69-S75. doi: 10.5005/jp-journals-10005-2040. PMID 35082471
  • Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available. PMID 5237684

Identifiers

NCT: NCT06825273 · # R-PED-1-25-3169

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗