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

Evaluation of Clinical Success and Changes in Periodontal Tissues of Band-Loop Space Maintainers Produced with Three-Dimensional Printer and Conventional Technique

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Dentistry; Dental Health; 3D Printing; Space Maintainer
• Intervention / Treatment: Device: Band and Loop Space Maintainer Produced with Three-Dimensional Printer; Device: Band and Loop Space Maintainer Produced with Conventional Technique

Detailed Description

Participants will be selected by simple random selection from systemically healthy children who will need bilateral lower deciduous first molar extraction and space maintainer application from patients who apply to Aydın Adnan Menderes University Faculty of Dentistry, Department of Pedodontics for treatment.

The study will be carried out in a split-mouth design, and it is planned to place a band and loop space maintainer produced by conventional technique on one side and a band and loop space maintainer produced with a three-dimensional printer on the other side in the lower jaw. The clinical success of these two appliances and the changes in periodontal tissues will be compared. In order to evaluate the clinical success, the survival of the appliances and the determined failure criteria (Dissolution of the bonding cement, Separation/breakage from solder area, Embedding of the space maintainer inside towards the gum, Loop distortion/breakage, Inflammation of the gingiva adjacent to/around the space maintainer, Plaque accumulation around the band) will be taken into consideration. In order to evaluate the effects on periodontal tissues, pocket depth, plaque index values, gingival index values will be recorded and PLAP-1 and TNF-a levels in the gingival groove fluid will be examined for more detailed periodontal examination.

The total planned follow-up period is 18 months, with patients invited for follow-up appointments at six-month intervals.

Evaluations will be made at the end of the study with repeated measurements at baseline and control sessions.

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sultan Keles, Associate Proffesor; Phone Number: +905318438557; Email: dtsultank@gmail.com
• Study Contact Backup: Name: Özgün Öztürk; Phone Number: +905347429962; Email: ozgun.ozturk.96@gmail.com

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Recruiting
    • Aydın Adnan Menderes University
    • Contact: Sultan Keles, Associate Professor; Phone Number: +905318438557; Email: dtsultank@gmail.com
    • Contact: Özgün Öztürk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Band and Loop Space Maintainer Produced with Three-Dimensional Printer (Study Group); 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 three-dimensional printer using micro laser sinterisation method
Active Comparator: Band and Loop Space Maintainer Produced with Conventional Technique (Control Group); 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; Band and loop space maintainer produced with conventional methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring space maintaining efficiency	With the help of a digital caliper, the contact points of the teeth adjacent to the extraction space will be measured and the effective protection of the space will be monitored. First measurement will be done right before the space maintainers' placement. The caliper measurement will be repeated at the 6th, 12th and 18th months.	Up to18 months
Comparing the two impression methods in terms of patient satisfaction.	Two different impression methods will be used for the two techniques in the impression phase required for the production of the space maintainers. For the appliance to be produced with a three-dimensional printer, digital impressions will be taken with 3Shape intraoral scanner. For the conventional space maintainer production, impressions will be taken with traditional impression spoons using alginate material. With the help of a Likert scale from 1 to 5(with the help of smiley faces), the satisfaction levels of the children about the impression phases will be measured right after the impression process finished.	Immediately after the impression procedure

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: TNF-a; digital dentistry; three dimensional printer; band and loop space maintainer; PLAP-1
• Other Study ID Numbers: 2023/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No