Health TrialsbyHealthPanel

Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer

ConditionsSpace MaintenanceGingival Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-9
SponsorTanta University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Crossover

Treatments tested in this trial

  • space maintainer

    Other intervention

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

  • space maintainer

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: conventional acrylic partial denture space maintainerActive comparator 0 interventions
Group B: 3-D printed partial denture space maintainerExperimental treatment 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
three months
2

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.

Time frame
three months
3

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.

Time frame
three months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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