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

NCT07591324 | Recruiting

• 2 other identifiers: 930/2024Organization's Unique Protocol
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Health; Space Maintenance; Pain and Anxiety

Keywords

lingual arch spacemaintainer; 3D printed spacemaintainer

Outcome Measures

Primary Outcomes (2)

• 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. 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.

  9 months

Secondary Outcomes (1)

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

  Day 1

Study Arms (2)

Group I

ACTIVE COMPARATOR

Conventional spacemaintainer

Device: Conventional spacemaintainer

Group II

EXPERIMENTAL

3D printed spacemaintainer

Device: 3D printed spacemaintainer

Interventions

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

Group I

3D printed spacemaintainer DEVICE

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

Group II

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Ismailia Governorate, 41522, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 24739908 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Reham M. Assistant Professor, PhD

CONTACT

+966545318171; reham_mohamed@dent.suez.edu.eg

Rim M. Lecturer, PhD

CONTACT

+201222726567; rim_fathalla@dent.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: May 15, 2026
• Study Start: January 22, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)