Suez Canal University
Ismailia, Ismailia Governorate, 41522, Egypt
Location status: Recruiting
Location contact
Reham M. Principle investigator, Assistant professor
CONTACT
Rim M. Co-investigator, Lecturer
CONTACT
NCT Number: NCT07591324
the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
Interested in participating?
Request Info7 year–9 year
All sexes
Interventional
Not applicable
Ismailia, Ismailia Governorate, 41522, Egypt
Location status: Recruiting
Reham M. Principle investigator, Assistant professor
CONTACT
Rim M. Co-investigator, Lecturer
CONTACT
Introduction and Review of literature Primary teeth serve to preserve inborn space until permanent teeth erupt, in addition they help with speech and mastication. It is appropriate to highlight the primary dentition's function as the best space maintainer for permanent teeth. It is possible that premature primary tooth loss will cause undesirable primary and permanent tooth movements, including a loss in arch length. If there is not enough arch length, it is more likely to predict malocclusions such as crowding and ectopic eruption as well as tooth impaction.
Since the largest space loss occurs within a month of losing the deciduous teeth, it is best to use a space maintainer as soon as possible after early tooth loss. Space maintainers are the orthodontic appliance of choice for preventing space loss because they preserve space within the oral cavity.
Conventional space maintainers have significant drawbacks despite their clinical effectiveness. These include the need for patient compliance, extended chairside times, multiple steps in the fabrication process, technique-sensitive impressions and lab procedures, solder failure, and caries formation at band margins.
These disadvantages in the conventional space maintainer recommend the need for more advanced appliance designs and materials, one of which is three-dimensional (3D) printing, The process involves creating 3D objects using a digitally scanned and layered design of the entire object. The design is preserved using a "Standard Tessellation Language" (STL) file.
So, the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two bands will be selected and checked for fit and adaptation around the distal abutment teeth, then an alginate impression will be taken and will be sent to the laboratory for fabrication
An intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.
Time frame: 9 months
Patient satisfaction and pain experienced during conventional and digital impression and cementation will be evaluated using the Wong-Baker Faces test and subsequently recorded for clinical satisfaction at 3 months, 6 months and 9 months for both patient groups to evaluate appliance acceptance and convenience for the patients.
Time frame: 9 months
gingival health will be evaluated by Sillness and Loe Gingival Index
Evaluation of the gingival health according to the (GI) described by (Loe and Silness, 1963):
Score Criteria for the Gingival Index 0 No inflammation.
Time frame: Day 1
Questions Answer by Yes (√) or (No) ×
Contact information is provided by the study sponsor or research team.
Reham M. Assistant Professor, PhD
CONTACT
Rim M. Lecturer, PhD
CONTACT
Suez Canal University
Other
Comparative Evaluation of the Conventional and Three-Dimensional Printed Lower Lingual Arch Space Maintainers A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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