Clinical trial NCT06798090: Evaluation of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique
Official title: Evaluation of Clinical Success and Changes in Periodontal Tissues of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Health
Space Maintainer
Pediatric Dentistry
3D Printing
Keywords: three dimensional printer
band and loop space maintainer
digital dentistry
PLAP-1
TNF-a
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 27
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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 outcomes:
measure: Clinical success
timeFrame: Up to 18 months
measure: Evaluation of periodontal tissue changes around both space maintainers according to the periodontal pocket depth measuring
timeFrame: Up to 18 months
measure: Evaluation of periodontal tissue changes around both space maintainers according to Plaque index values
timeFrame: Up to 18 months
measure: Evaluation of periodontal tissue changes around both space maintainers according to the gingival index values
timeFrame: Up to 18 months
measure: Evaluation of periodontal tissue changes around both space maintainers with gingival groove fluid examination
timeFrame: Baseline and 6.month
Secondary outcomes:
measure: Measuring space maintaining efficiency
timeFrame: Up to18 months
measure: Comparing the two impression methods in terms of patient satisfaction.
timeFrame: Immediately after the impression procedure
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University
Study officials:
References: