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

Not Applicable

Recruiting

• Conditions: Dental Health; Space Maintainer; Pediatric Dentistry; 3D Printing

• Registration Number: NCT06798090
• Lead Sponsor: Aydin Adnan Menderes University

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.

Study Timeline

• Study First Submitted: 2024-10-06
• Study Start: 2024-10-15
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Measuring space maintaining efficiency	Up to18 months	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.
Comparing the two impression methods in terms of patient satisfaction.	Immediately after the impression procedure	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.

Trial Locations

Locations (1)

Aydın Adnan Menderes University; 🇹🇷 Aydın, Turkey