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Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer

T

Tanta University

Status

Enrolling

Conditions

Gingival Health
Space Maintenance

Treatments

Other: space maintainer

Study type

Interventional

Funder types

Other

Identifiers

NCT06825273
# R-PED-1-25-3169

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

7 to 9 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

40 participants in 2 patient groups

conventional acrylic partial denture space maintainer
Active Comparator group
Description:
an elastomeric impression will be done to produce a plaster cast then a conventional acrylic partial space maintainer will be fabricated and delivered for the child patient.
3-D printed partial denture space maintainer
Experimental group
Description:
A 3-D intraoral scanner will be used to produce digital models. STL file will be used to design a 3-D printed partial denture space maintainer which will be delivered to the child patient.

Trial contacts and locations

2

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Central trial contact

shaimaa eldesouky, assistant professor

Data sourced from clinicaltrials.gov

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