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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.

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

Recruiting

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Key information

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, Ismailia Governorate, 41522, Egypt

Location status: Recruiting

Location contact

Reham M. Principle investigator, Assistant professor

CONTACT

[email protected]

0545318171

Rim M. Co-investigator, Lecturer

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional spacemaintainer

Device

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

3D printed spacemaintainer

Device

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

Primary outcomes

  1. Patient satisfaction and pain experienced using the Wong-Baker Faces Test

    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.

  2. Gingival health will be evaluated using Sillness and Loe Gingival Index

    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.

    • Mild inflammation: slight redness, slight edema, no bleeding on probing.
    • Moderate inflammation: redness, edema, glazing, bleeding on probing.
    • Severe inflammation: marked redness and edema, ulceration, and a tendency of spontaneous bleeding.

Secondary outcomes

  1. Impression taking experience for the patient assessed by 6-questions survey

    Time frame: Day 1

    Questions Answer by Yes (√) or (No) ×

    • Was the impression easy?
    • Did you feel nausea during impression taking?
    • Any malaise during impression taking ( bad taste,odour, foreign body)?
    • Did impression take short time?
    • Would you repeat this impression experience again?
    • Did you feel any stress during impression taking?

Study contacts

Contact information is provided by the study sponsor or research team.

Reham M. Assistant Professor, PhD

CONTACT

[email protected]

+966545318171

Rim M. Lecturer, PhD

CONTACT

[email protected]

+201222726567

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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