About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with systemic diseases
Frankl score 1 and 2 children
Trial design
Parallel
Treatments tested in this trial
Band and Loop Space Maintainer Produced with Three-Dimensional Printer
DeviceBand and loop space maintainer produced with three-dimensional printer using micro laser sinterisation method
Band and Loop Space Maintainer Produced with Conventional Technique
DeviceBand and loop space maintainer produced with conventional methods
Treatment groups
Trial 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).
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).
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.
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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