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the Objective of This Research is to Compare the Clinical Effectiveness of the Conventional Lingual Arch Space Maintainers With Three-dimensional Printed Space Maintainers.

Comparative Evaluation of the Conventional and Three-Dimensional Printed Lower Lingual Arch Space Maintainers A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07591324
Enrollment
44
Registered
2026-05-15
Start date
2025-01-22
Completion date
2026-09-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Health, Pain and Anxiety, Space Maintenance

Keywords

lingual arch spacemaintainer, 3D printed spacemaintainer

Brief summary

the objective of this research is to compare the clinical effectiveness of the conventional lingual arch space maintainers with three-dimensional printed space maintainers.

Detailed description

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.

Interventions

DEVICEConventional spacemaintainer

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

DEVICE3D printed spacemaintainer

An intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

* Apparently, healthy cooperative children have recently prematurely loss of more than one mandibular primary molar in any of the quadrants, full erupted mandibular first permanent molars in both sides, and whose lower permanent incisors have erupted * 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 * Caries-free and periodontally healthy abutment teeth * Absence of parafunctional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite. * Children's age ranges from 7 to 9 years-old * Radiographically, presence of permanent successors, more than one millimeter of bone covering the successor tooth germ, and/or only about one-third of the root of the permanent tooth has been formed. * 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

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction and pain experienced using the Wong-Baker Faces Test9 monthsPatient 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.
Gingival health will be evaluated using Sillness and Loe Gingival Index9 monthsgingival 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. 1. Mild inflammation: slight redness, slight edema, no bleeding on probing. 2. Moderate inflammation: redness, edema, glazing, bleeding on probing. 3. Severe inflammation: marked redness and edema, ulceration, and a tendency of spontaneous bleeding.

Secondary

MeasureTime frameDescription
Impression taking experience for the patient assessed by 6-questions surveyDay 1Questions Answer by Yes (√) or (No) × 1. Was the impression easy? 2. Did you feel nausea during impression taking? 3. Any malaise during impression taking ( bad taste,odour, foreign body)? 4. Did impression take short time? 5. Would you repeat this impression experience again? 6. Did you feel any stress during impression taking?

Countries

Egypt

Contacts

CONTACTReham M. Assistant Professor, PhD
reham_mohamed@dent.suez.edu.eg+966545318171
CONTACTRim M. Lecturer, PhD
rim_fathalla@dent.suez.edu.eg+201222726567

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026