Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer

NCT06825273 | Recruiting

• 1 other identifier: # R-PED-1-25-3169
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Space Maintenance; Gingival Health

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

conventional acrylic partial denture space maintainer

ACTIVE COMPARATOR

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

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.

Interventions

space maintainer OTHER

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

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

pediatric dentistry department, faculty of dentistry, Tanta university

Tanta, 31527, Egypt

RECRUITING

Tanta University

Tanta, 31527, Egypt

NOT YET RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

shaimaa eldesouky, assistant professor

CONTACT

+201008994242; shaimaaeldesouky@dent.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of pediatric dentistry

Model Details: A Randomized Controlled Clinical Crossover Study

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

EG (2)