Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer

NCT ID: NCT06825273

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-10-31

Brief Summary

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Primary dentition is the most suitable space maintainer for permanent teeth. However, as infants often lose their primary teeth too soon, using a space maintainer is the most efficient, long-lasting, and economical way to prevent malocclusions and function impairment in the future. Regarding personalized appliances, space maintainers in digital pediatric dentistry have made significant progress. Digital technology decreases the manual manufacturing stages that take a long time and increases the reliability and durability of digital fabrication procedures.

Detailed Description

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Conditions

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Space Maintenance Gingival Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A Randomized Controlled Clinical Crossover Study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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conventional acrylic partial denture space maintainer

an elastomeric impression will be done to produce a plaster cast then a conventional acrylic partial space maintainer will be fabricated and delivered for the child patient.

Group Type ACTIVE_COMPARATOR

No interventions assigned to this group

3-D printed partial denture space maintainer

A 3-D intraoral scanner will be used to produce digital models. STL file will be used to design a 3-D printed partial denture space maintainer which will be delivered to the child patient.

Group Type EXPERIMENTAL

No interventions assigned to this group

Interventions

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space maintainer

3-D printed partial denture space maintainer will designed for each child patient who has premature loss of primary teeth after doing intraoral scanning

Intervention Type OTHER

space maintainer

a conventional impression will be done for a child patient with premature loss of his primary teeth, then a plaster model will gained. A conventional acrylic partial denture will be designed and delivered to the patient.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* apparently, healthy cooperative children having recent premature loss of lower primary molars
* 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
* Presence of teeth on the mesial and distal side of the edentulous area
* Absence of para-functional habits or abnormal occlusion conditions such as crossbite, open bite, or deep bite.
* Radiographically, presence of permanent successors.
* 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Shaban Mohamed El-desouky

assistant professor of pediatric dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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pediatric dentistry department, faculty of dentistry, Tanta university

Tanta, , Egypt

Site Status RECRUITING

Tanta University

Tanta, , Egypt

Site Status NOT_YET_RECRUITING

Countries

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Egypt

Central Contacts

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shaimaa eldesouky, assistant professor

Role: CONTACT

+201008994242

Facility Contacts

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shaimaa eldesouky, assistant professor

Role: primary

01008994242

shaimaa eldesouky, assistant professor

Role: primary

01008994242

References

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Guo H, Wang Y, Zhao Y, Liu H. Computer-aided design of polyetheretherketone for application to removable pediatric space maintainers. BMC Oral Health. 2020 Jul 10;20(1):201. doi: 10.1186/s12903-020-01184-6.

Reference Type BACKGROUND
PMID: 32650758 (View on PubMed)

Dhanotra KG, Bhatia R. Digitainers-Digital Space Maintainers: A Review. Int J Clin Pediatr Dent. 2021;14(Suppl 1):S69-S75. doi: 10.5005/jp-journals-10005-2040.

Reference Type BACKGROUND
PMID: 35082471 (View on PubMed)

Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

Reference Type BACKGROUND
PMID: 5237684 (View on PubMed)

Other Identifiers

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# R-PED-1-25-3169

Identifier Type: -

Identifier Source: org_study_id

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