Clinical trial NCT06825273: Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Space Maintenance
Gingival Health
Keywords: partial denture space maintainer
3-D printing
plaque index
gingival index
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Randomized Controlled Clinical Crossover Study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: clinical evaluation
timeFrame: three months
measure: gingival health
timeFrame: three months
measure: plaque index
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: pediatric dentistry department, faculty of dentistry, Tanta university
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.