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

Suez Canal University44 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gingival Health Space Maintenance Pain and Anxiety

Interventions

Conventional spacemaintainerDEVICE

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 spacemaintainerDEVICE

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

Eligibility

Sex: ALLMin age: 7 YearsMax age: 9 Years

Medical Language ↔ Plain English

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

Locations (1)

Suez Canal University

Ismailia, Ismailia Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 9 months

Secondary Outcomes

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

Questions 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?

Time frame: Day 1

Central 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

Data from ClinicalTrials.gov

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