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Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06825273
Enrollment
40
Registered
2025-02-13
Start date
2025-03-01
Completion date
2025-10-31
Last updated
2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Health, Space Maintenance

Keywords

partial denture space maintainer, 3-D printing, plaque index, gingival index

Brief summary

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

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

A Randomized Controlled Clinical Crossover Study

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
clinical evaluationthree monthsthe 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
plaque indexthree monthsusing 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.
gingival healththree monthsusing 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.

Countries

Egypt

Contacts

Primary Contactshaimaa eldesouky, assistant professor
shaimaaeldesouky@dent.tanta.edu.eg+201008994242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026