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

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.

Study Overview

• Status: Recruiting
• Conditions: Space Maintenance; Gingival Health
• Intervention / Treatment: Other: space maintainer; Other: space maintainer

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: shaimaa eldesouky, assistant professor; Phone Number: +201008994242; Email: shaimaaeldesouky@dent.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Recruiting
    • pediatric dentistry department, faculty of dentistry, Tanta university
    • Contact: shaimaa eldesouky, assistant professor; Phone Number: 01008994242; Email: shaimaaeldesouky@dent.tanta.edu.eg
  • Tanta, Egypt, 31527
    • Not yet recruiting
    • Tanta University
    • Contact: shaimaa eldesouky, assistant professor; Phone Number: 01008994242; Email: shaimaaeldesouky@dent.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional acrylic partial denture space maintainer; 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.
Experimental: 3-D printed partial denture space maintainer; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical evaluation	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	three months
gingival health	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.	three months
plaque index	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.	three months

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 8, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: 3-D printing; gingival index; plaque index; partial denture space maintainer
• Other Study ID Numbers: # R-PED-1-25-3169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No