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

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

Study Overview

• Status: Recruiting
• Conditions: Pain and Anxiety; Space Maintenance; Gingival Health
• Intervention / Treatment: Device: Conventional spacemaintainer; Device: 3D printed spacemaintainer

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reham M. Assistant Professor, PhD; Phone Number: +966545318171; Email: reham_mohamed@dent.suez.edu.eg
• Study Contact Backup: Name: Rim M. Lecturer, PhD; Phone Number: +201222726567; Email: rim_fathalla@dent.suez.edu.eg

Study Locations

• Egypt
  • Ismailia Governorate
    • Ismailia, Ismailia Governorate, Egypt, 41522
      • Recruiting
      • Suez Canal University
      • Contact: Reham M. Principle investigator, Assistant professor; Phone Number: 0545318171; Email: reham_mohamed@dent.suez.edu.eg
      • Contact: Rim M. Co-investigator, Lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; Conventional spacemaintainer	Device: Conventional 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
Experimental: Group II; 3D printed spacemaintainer	Device: 3D printed spacemaintainer; An intraoral scan for the patients' lower arch will be taken using a 3D digital dental scanner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction and pain experienced using the Wong-Baker Faces Test	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.	9 months
Gingival health will be evaluated using Sillness and Loe Gingival Index	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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impression taking experience for the patient assessed by 6-questions survey	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?	Day 1

Collaborators and Investigators

• Sponsor: Suez Canal University

Publications and helpful links

General Publications

• Garg A, Samadi F, Jaiswal JN, Saha S. 'Metal to resin': a comparative evaluation of conventional band and loop space maintainer with the fiber reinforced composite resin space maintainer in children. J Indian Soc Pedod Prev Dent. 2014 Apr-Jun;32(2):111-6. doi: 10.4103/0970-4388.130783.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: lingual arch spacemaintainer; 3D printed spacemaintainer
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: 930/2024; Organization's Unique Protocol (Other Identifier: 930/2024)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: may be after publishing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No