Dental HealthNCT06798090
Evaluation of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique
A study testing Band and Loop Space Maintainer Produced with Three-Dimensional Printer and Band and Loop Space Maintainer Produced with Conventional Technique in people with Dental Health and Space Maintainer, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Dental Health, Space Maintainer, Pediatric Dentistry
- What is being tested?
- Band and Loop Space Maintainer Produced with Three-Dimensional Printer and Band and Loop Space Maintainer Produced with Conventional Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients with systemic diseases
- Frankl score 1 and 2 children
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydın Adnan Menderes University
Aydin, Aydın, 09100
Sultan Keles, Associate Professor, +905318438557, dtsultank@gmail.com
Özgün Öztürk
About this study
Official title: Evaluation of Clinical Success and Changes in Periodontal Tissues of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique
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.
Read the 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.
- Conditions
- Dental Health, Space Maintainer, Pediatric Dentistry, 3D Printing
- Being tested
- Band and Loop Space Maintainer Produced with Three-Dimensional Printer, Band and Loop Space Maintainer Produced with Conventional Technique
- Keywords
- three dimensional printer, band and loop space maintainer, digital dentistry, PLAP-1, TNF-a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Band and Loop Space Maintainer Produced with Three-Dimensional Printer (Study Group) | Experimental | Digital impressions will be taken with 3Shape intraoral scanner. Space maintainer will be designed with CAD/CAM technology. The three-dimensional printer to be used is HBD - 150D Dual Laser, and production will be made by micro laser sinterisation method from nickel - chromium weighted metal powders. Receives: Device: Band and Loop Space Maintainer Produced with Three-Dimensional Printer |
| Band and Loop Space Maintainer Produced with Conventional Technique (Control Group) | Active comparator | For conventional production, impressions will be taken with traditional impression spoons using alginate material. Stainless steel appropriate band will be chosen according to the size of the abutment teeth, then will be send to the laboratory for soldering. Receives: Device: Band and Loop Space Maintainer Produced with Conventional Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6.month
Secondary outcomes (2)
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.
Measured: Up to18 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.
Measured: Immediately after the impression procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start15 Oct 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental HealthStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan KELES, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798090
- Sponsor's protocol ID
- 2023/21
- Status last verified
- Jan 2025
- First submitted
- 6 Oct 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Success and Changes in Periodontal Tissues of Band-Loop Space Maintainers Produced With Three-Dimensional Printer and Conventional Technique
- ClinicalTrials.gov ID
- NCT06798090
- Acronym / sponsor ID
- 2023/21
- Conditions
- Dental Health, Space Maintainer, Pediatric Dentistry, 3D Printing
- Keywords
- three dimensional printer, band and loop space maintainer, digital dentistry, PLAP-1, TNF-a
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Band and Loop Space Maintainer Produced with Three-Dimensional Printer (Study Group) | Experimental | Device: Band and Loop Space Maintainer Produced with Three-Dimensional PrinterDigital impressions will be taken with 3Shape intraoral scanner. Space maintainer will be designed with CAD/CAM technology. The three-dimensional printer to be used is HBD - 150D Dual Laser, and production will be made by micro laser sinterisation method from nickel - chromium weighted metal powders. |
| Band and Loop Space Maintainer Produced with Conventional Technique (Control Group) | Active comparator | Device: Band and Loop Space Maintainer Produced with Conventional TechniqueFor conventional production, impressions will be taken with traditional impression spoons using alginate material. Stainless steel appropriate band will be chosen according to the size of the abutment teeth, then will be send to the laboratory for soldering. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with systemic diseases
- Frankl score 1 and 2 children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Band and Loop Space Maintainer Produced with Three-Dimensional PrinterBand and loop space maintainer produced with three-dimensional printer using micro laser sinterisation method | Device | Band and Loop Space Maintainer Produced with Three-Dimensional Printer (Study Group) |
| Band and Loop Space Maintainer Produced with Conventional TechniqueBand and loop space maintainer produced with conventional methods | Device | Band and Loop Space Maintainer Produced with Conventional Technique (Control Group) |
Primary outcome
Clinical success
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Measuring space maintaining efficiency
Time frame: Up to18 months
Comparing the two impression methods in terms of patient satisfaction.
Time frame: Immediately after the impression procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Band and Loop Space Maintainer Produced with Three-Dimensional Printer and Band and Loop Space Maintainer Produced with Conventional Technique in people with Dental Health and Space Maintainer, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sultan Keles, Associate Proffesor (+905318438557, dtsultank@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: Up to 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.