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

Aydin Adnan Menderes University27 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Dental Health Space Maintainer Pediatric Dentistry 3D Printing

Interventions

Band and Loop Space Maintainer Produced with Three-Dimensional PrinterDEVICE

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

Band and Loop Space Maintainer Produced with Conventional TechniqueDEVICE

Band and loop space maintainer produced with conventional methods

Eligibility

Sex: ALLMin age: 5 YearsMax age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

Aydın Adnan Menderes University

Aydin, Aydın, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.