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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-8
SponsorAydin Adnan Menderes University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Band and Loop Space Maintainer Produced with Three-Dimensional Printer

    Device

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

  • Band and Loop Space Maintainer Produced with Conventional Technique

    Device

    Band and loop space maintainer produced with conventional methods

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: Band and Loop Space Maintainer Produced with Three-Dimensional Printer (Study Group)Experimental treatment 1 intervention
Group B: Band and Loop Space Maintainer Produced with Conventional Technique (Control Group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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.

Time frame
Up to18 months
2

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.

Time frame
Immediately after the impression procedure

Other outcomes

Sponsors and contacts

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