Comparative evaluation of the survival rate and gingival health of 3D printed band and loop space maintainer with conventional band and loop space maintainer in children

Phase 1

Not yet recruiting

• Conditions: Disturbances in tooth eruption,

• Registration Number: CTRI/2020/11/029271

Brief Summary

The present in vivo study aimed to compare 3D printed vs. conventional band and loop Space Maintainers(SM) and evaluate their survival rate and gingival health in children and to obtain results for which is the best Space maintainer in terms of survival rate and gingival health by including 20 patients of age 4 to 9 years with 20 extraction sites will be selected after obtaining written informed consent from the parents of the child. And the two types of BAND &LOOP SM will be fabricated and will be divided into two groups Group I(n=10) - CONVENTIONAL BAND &LOOP SM, Group II(n=10)  – 3D BAND &LOOP SM. A brief history will be recorded, and clinical examination will be done, Intraoral periapical radiographs will be taken in areas of tooth loss, Study models will be prepared, and space analysis will be carried out for every child, For every selected child, oral prophylaxis will be done before placement of a space maintainer and a conventional band and loop will be fabricated according to the technique described by Finn, and for 3D printed space maintainer edentulous space will be scanned using a 3D digital dental scanner followed by the designing of the band and loop similar to the conventional SM, on computer and fabrication will be done using a 3D printer with the material ABS. Both the types of space maintainers will be luted to the teeth in both the groups using type I  Glass Ionomer Cement. Instructions for oral hygiene and appliance maintenance will be given to children and their parents. Patients will be recalled at 3rd and 6th months for evaluation of space maintainers using the criteria for assessing survival rate and gingival health. The results obtained from the criteria mentioned above will be tabulated accordingly and evaluated for statistical significance. The data collected at the 3rd and 6th months will be subjected to statistical analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients in the age group of 4 to 9 years.
• Extraction sites or teeth indicated for extraction with no space loss.
• Erupting permanent teeth having adequate bone covering.
• Fully erupted carious free teeth, will be included in the study.

Exclusion Criteria

• Patients not in the age group of 4 to 9 years.
• teeth not indicated for extraction.
• extraction sites with space loss.
• permanent teeth having non adequate bone covering.
• partially erupted carious teeth.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3D printed band and loop space maintainer will have a better survival rate and gingival health compared to conventional band and loop space maintainer in children	9 months

Secondary Outcome Measures

Name	Time	Method
There is no significant difference between survival rate and gingival health of 3D printed vs. conventional band and loop space maintainers in children	9 months

Trial Locations

Locations (1)

Department of Pediatric and Preventive Dentistry; 🇮🇳 Godavari, ANDHRA PRADESH, India

Department of Pediatric and Preventive Dentistry

🇮🇳Godavari, ANDHRA PRADESH, India

G L G S PRUDHVI KUMAR

Principal investigator

9398850377

prudhvi.gannamani@gmail.com