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

NCT06798090 · tracked via the Priya Life Science Turkey tracker

Sponsor

Aydin Adnan Menderes University

Phase

Not applicable

Started

2024-10-15

Last updated

2025-01-29

Condition(s) studied

Dental HealthSpace MaintainerPediatric Dentistry3D Printing

Investigational drug(s) / intervention(s)

Band and Loop Space Maintainer Produced with Three-Dimensional PrinterBand and Loop Space Maintainer Produced with Conventional Technique

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

Band and Loop Space Maintainer Produced with Conventional Technique: Band and loop space maintainer produced with conventional methods

Study 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.

Eligibility

Sex

ALL

Min age

5 Years

Max age

8 Years

Healthy volunteers

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

Primary outcome measure(s)

Clinical success — Up to 18 months
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).
Evaluation of periodontal tissue changes around both space maintainers according to the periodontal pocket depth measuring — Up to 18 months
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).
Evaluation of periodontal tissue changes around both space maintainers according to Plaque index values — Up to 18 months
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.
Evaluation of periodontal tissue changes around both space maintainers according to the gingival index values — Up to 18 months
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.
Evaluation of periodontal tissue changes around both space maintainers with gingival groove fluid examination — Baseline and 6.month
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.

Trial sites (1)

Facility	City	Region	Status
Aydın Adnan Menderes University	Aydin	Aydın	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06798090 on ClinicalTrials.gov ↗ ← All trials in Turkey