3D printed space maintainer (3D-SM) vs. traditional band and loop space maintainer (C-BLSM)

Phase 2

Not yet recruiting

Conditions: Disturbances in tooth eruption,

Registration Number: CTRI/2023/06/054553

Lead Sponsor: Dr Anuj Bhardwaj

Brief Summary: The premature loss of primary teeth can lead to several dental problems, including space loss, malocclusion, and impacted permanent teeth. Space maintainers (SMs) are dental devices used to preserve space and prevent these problems from occurring. The most used SMs are the conventional band and loop space maintainers (C-BLSM), which are fabricated in a dental laboratory and require multiple visits for placement.

Recent advancements in technology have led to the development of 3D printing in dentistry, which has the potential to revolutionize the fabrication of SMs. The 3D printed space maintainer (3D-SM) is a novel device that can be custom-designed and fabricated in a single visit. However, there is limited research on the effectiveness of 3D-SMs compared to traditional C-BLSMs.

Therefore, this randomized clinical trial aims to compare the effectiveness of 3D-SMs and C-BLSMs in preserving space and preventing dental problems following the loss of primary teeth. The trial will assess the survival rate, clinical performance, and patient satisfaction of both types of SMs. The study will also evaluate the time and cost required for the fabrication and placement of each type of SM. The findings of this study will provide valuable insights into the effectiveness of 3D-SMs compared to traditional C-BLSMs and their potential for use in clinical practice. This research will also contribute to the growing body of literature on the application of 3D printing technology in dentistry and its potential to improve patient outcomes.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria Clinical criteria Systemically healthy children.
Grossly mutilated single molars on either side, requiring extraction.
Freshly extracted single molars bilaterally in the same arch or opposite arch.
Sound and healthy teeth adjacent to the extraction site.
No abnormal dental conditions such as crossbite, open bite, and deep bite.
Radiographic criteria Presence of succedaneous tooth bud.
Presence of at least 1 mm bone overlying the succedaneous tooth germ with less than one-third of the root formed.

Exclusion Criteria

Grossly carious teeth were adjacent to the created space.
Absence of teeth on the mesial or distal side of the teeth to be extracted.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival Time of Space maintainers compared	follow up intervals 0 1 3 6 and 9 months
Gingival Health of the Abutment Tooth	follow up intervals 0 1 3 6 and 9 months

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	follow up intervals 0 1 3 6 and 9 months

Trial Locations

Locations (1): College Of Dental Science and Hospital
🇮🇳
Indore, MADHYA PRADESH, India
College Of Dental Science and Hospital
🇮🇳Indore, MADHYA PRADESH, India
Dr Anuj Bhardwaj
Principal investigator
7898540222
dranuj_84@yahoo.co.in