comparison between 3D printed space maintainer and prefabricated stainless steel space maintainer

Phase 2

Completed

• Conditions: Partial loss of teeth,

• Registration Number: CTRI/2023/10/058547
• Lead Sponsor: JAHANA SHERIN IM

Brief Summary

The study’s aim is to compare and evaluate the clinical performance of 3D printed space maintainer using PEEK polymer with that of prefabricated stainless steel space maintainer. The result of the study will give additional information regarding the potential use of PEEK polymer material in fabrication of space maintainer.

It is an in-vivo experimental study with 15 children of age group 6-9 years reporting to dept. of pediatric and preventive dentistry, Yenepoya Dental College, who has two posterior edentulous spaces and indicated for space maintainers.

The study will be commenced only after approval from the institutional ethical committee. Once inclusion and exclusion criteria are satisfied consent from parents and child will be obtained prior to the study.

Impressions of upper and lower arch will be made using rubber-based impression material and then Casts will be poured. The cast will be sent to 3D lab at Yenepoya Incubation Centre for the fabrication of 3D space. And then the appliance will be sterilized according to standard sterilization protocol. Prefabricated space maintainer will be adapted on one edentulous space according to user instructions and 3D designed space maintainer using PEEK will be fixed on the other edentulous space. Both the space maintainers will be luted by using resin modified GIC.

All the procedure will be carried out by single operator. At the end of 6 months, patient will be recalled and parameters like plaque index, gingival index, survival time, patient satisfaction will be evaluated and documented. The above results will be subjected to statistical analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-20
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Children of age group 6-9 years with two posterior edentulous spaces due to premature loss of deciduous molars and indicated for space maintainer.

Exclusion Criteria

Medically compromised patients Patients with high caries index Children with dental abnormalities (cross bite/open bite/deep bite) Children with loss of space.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CLINICAL SUCCESS RATE OF 3D PRINTED SPACE MAINTAINER AND PREFABRICATED SPACE MAINTAINER IN PEDIATRIC DENTISTRY INTERMS OF PLAQUE INDEX, GINGIVAL INDEX, RETENTION AND SURVIVAL TIME	6 months

Secondary Outcome Measures

Name	Time	Method
CLINICAL SUCCESS RATE OF 3D PRINTED SPACE MAINTAINER AND PREFABRICATED SPACE MAINTAINER IN PEDIATRIC DENTISTRY INTERMS OF PATIENTS SATISFACTION USING VISUAL ANALOGUE SCALE	end of 6 months

Trial Locations

Locations (1)

YENEPOYA DENTAL COLLEGE MANGALORE; 🇮🇳 Kannada, KARNATAKA, India

YENEPOYA DENTAL COLLEGE MANGALORE

🇮🇳Kannada, KARNATAKA, India

DR AJAY RAO HT

Principal investigator

9845085048

drajayrao@gmail.com