Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer

Not Applicable

Recruiting

• Conditions: Space Maintenance; Gingival Health

• Registration Number: NCT06825273
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-08
• Study First Submitted QC: 2025-02-08
• Study First Posted: 2025-02-13
• Study Start: 2025-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
clinical evaluation	three months	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
gingival health	three months	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.
plaque index	three months	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.

Trial Locations

Locations (2)

pediatric dentistry department, faculty of dentistry, Tanta university; 🇪🇬 Tanta, Egypt

Tanta University; 🇪🇬 Tanta, Egypt