Evaluation of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique

NCT06798090 | Recruiting

• 1 other identifier: 2023/21
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Our research is planned as a randomised clinical trial. The main aim of our study is to evaluate the clinical success of band and loop space maintainers produced by three-dimensional printer and conventional technique and the changes they cause in periodontal tissues.

Conditions

Dental Health; Space Maintainer; Pediatric Dentistry; 3D Printing

Keywords

three dimensional printer; band and loop space maintainer; digital dentistry; PLAP-1; TNF-a

Outcome Measures

Primary Outcomes (5)

• Clinical success

  The clinical success rate of appliances in terms of survival time by checking both space maintainers for these failure criteria: Dissolution of the bonding cement, loop distortion/breakage, separation/breakage from solder area ( for soldered conventional band and loop space maintainer).

  Up to 18 months

• Evaluation of periodontal tissue changes around both space maintainers according to the periodontal pocket depth measuring

  The pocket depth will be measured by probing the six sides of the teeth (mesio-buccal, mesio-lingual, disto-buccal, disto-lingual, mid-buccal, mid-lingual).

  Up to 18 months

• Evaluation of periodontal tissue changes around both space maintainers according to Plaque index values

  Plaque index, that is running in a scale from 0 to 3 where 0 means no plaque,1 film of plaque adhering to free gingival margin,2 moderate accumulation of soft deposits on the tooth and gingival margin, and 3 means abundance of soft debris.

  Up to 18 months

• Evaluation of periodontal tissue changes around both space maintainers according to the gingival index values

  In order to evaluate the effects of both space maintainers on periodontal tissues, gingival index values will be recorded at baseline, 6th, 12th and 18th months. Gingival index, scores from 0 to 3 where 0 no inflammation, 1slight redness no bleeding on probing, 2 redness and bleeding on probing, and 3 severe inflammation with edema and ulceration to spontaneous bleeding.

  Up to 18 months

• Evaluation of periodontal tissue changes around both space maintainers with gingival groove fluid examination

  For detailed periodontal evaluation, PLAP-1 and TNF-a levels in the gingival groove fluid will be examined at the baseline and 6th month visits. Gingival groove fluid samples will be taken from two separate points of the teeth which the bands of the band and loop space maintainers' had been placed, with PerioPaper strips. Afterwards, the strips taken from each tooth will be packaged separately in eppendorf tubes and stored at -80 degrees until it is time to evaluate. The samples will be evaluated by ELISA tests then the results will be compared.

  Baseline and 6.month

Secondary Outcomes (2)

• Measuring space maintaining efficiency

  Up to18 months

• Comparing the two impression methods in terms of patient satisfaction.

  Immediately after the impression procedure

Study Arms (2)

Band and Loop Space Maintainer Produced with Three-Dimensional Printer (Study Group)

EXPERIMENTAL

Digital impressions will be taken with 3Shape intraoral scanner. Space maintainer will be designed with CAD/CAM technology. The three-dimensional printer to be used is HBD - 150D Dual Laser, and production will be made by micro laser sinterisation method from nickel - chromium weighted metal powders.

Device: Band and Loop Space Maintainer Produced with Three-Dimensional Printer

Band and Loop Space Maintainer Produced with Conventional Technique (Control Group)

ACTIVE COMPARATOR

For conventional production, impressions will be taken with traditional impression spoons using alginate material. Stainless steel appropriate band will be chosen according to the size of the abutment teeth, then will be send to the laboratory for soldering.

Device: Band and Loop Space Maintainer Produced with Conventional Technique

Interventions

Band and Loop Space Maintainer Produced with Three-Dimensional Printer DEVICE

Band and loop space maintainer produced with three-dimensional printer using micro laser sinterisation method

Band and Loop Space Maintainer Produced with Three-Dimensional Printer (Study Group)

Band and Loop Space Maintainer Produced with Conventional Technique DEVICE

Band and loop space maintainer produced with conventional methods

Band and Loop Space Maintainer Produced with Conventional Technique (Control Group)

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Systemically healthy children
• Bilateral early loss of deciduous first molar teeth in the lower jaw
• Presence of radiographically confirmed permanent tooth germ under the extracted deciduous tooth
• Radiographically determined 1,5 mm minimum of bone existence above the permanent tooth germ
• Existence of flush terminal plane/mesial step in decidious dentition and Angle class 1 molar relationship in mixed dentition
• Existence of radiographically and clinically healthy abutment teeth
• Frankl score 3 and 4 children

You may not qualify if:

• Patients with systemic diseases
• Frankl score 1 and 2 children

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Aydın, 09100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Chromosome Banding

Intervention Hierarchy (Ancestors)

Cytogenetic Analysis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Staining and Labeling; Histocytological Preparation Techniques; Histological Techniques; Investigative Techniques; Genetic Techniques

Central Study Contacts

Sultan Keles, Associate Proffesor

CONTACT

+905318438557; dtsultank@gmail.com

Özgün Öztürk

CONTACT

+905347429962; ozgun.ozturk.96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: January 29, 2025
• Study Start: October 15, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)