Premature Loss of Primary MolarsNCT07828158
Chewing Pattern Changes Before and After Space Maintainer Placement in Children
An observational study of Premature Loss of Primary Molars, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate changes in chewing patterns and chewing performance in children before and after placement of a unilateral fixed band-and-loop space maintainer. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Premature Loss of Primary Molars
- What is being tested?
- Band-and-Loop Space Maintainer
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2026to 30 Dec 2026
- Phase
- Observational
- 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 6 to 10 years
- All sexes
- Child
Study population: Children aged 6-10 years attending the Department of Pediatric Dentistry at Marmara University Faculty of Dentistry who have premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer. Eligible children will be recruited prospectively from patients scheduled to receive space maintainer treatment as part of routine clinical care.
Who may be able to join
- Children aged 6-10 years
- Premature loss or extraction of a primary molar in the maxilla or mandible with a clinical indication for a unilateral fixed band-and-loop space maintainer
- The abutment tooth for the space maintainer is vital and either sound or appropriately restored
- Complete dentition on the contralateral side of the arch to allow reliable assessment of chewing function
- No systemic condition affecting chewing function
- Written informed consent provided by a parent or legal guardian; children aged 9 years and older also provide written assent
Who cannot join
- Severe developmental delay, severe behavioral problems, or neuromuscular disorders that may directly affect chewing function, muscle activity, or treatment cooperation
- Temporomandibular joint disorder
- Current orthodontic treatment
- Anterior or posterior crossbite, open bite, or other skeletal or dental malocclusions that may affect chewing function
- Additional missing teeth in the contralateral arch, including hypodontia
- Craniofacial anomalies, including cleft lip and/or palate syndromes
- Systemic conditions requiring special medical precautions or antibiotic prophylaxis during routine dental treatment
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
Marmara University
Istanbul, Maltepe
savas, 90 5343279274, aafranursavas@gmail.com
About this study
Official title: Evaluation of Changes in Chewing Pattern in Children Before and After Space Maintainer Placement
This prospective observational study aims to evaluate changes in chewing patterns and chewing performance in children before and after placement of a unilateral fixed band-and-loop space maintainer. Children aged 6-10 years who require a space maintainer as part of routine clinical care will be evaluated before appliance placement and again four weeks after placement. Chewing pattern will be assessed by observing the preferred chewing side during standardized chewing trials, and chewing performance will be evaluated using a two-color chewing gum test scored with the Orophys Subjective Assessment Scale. No additional invasive procedure will be performed for research purposes; the space maintainer treatment will be provided as part of routine clinical care.
- Conditions
- Premature Loss of Primary Molars
- Being tested
- Band-and-Loop Space Maintainer
- Keywords
- Space Maintainer, Chewing Pattern, Two-Color Chewing Gum Test, Pediatric Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Band-and-Loop Space MaintainerDevice
A unilateral fixed band-and-loop space maintainer will be placed as part of routine clinical care following premature loss of a primary molar. The appliance will be cemented to the abutment tooth with glass ionomer cement, and occlusion will be checked after placement. The space maintainer is not assigned for research purposes; it is clinically indicated before study enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Children Receiving a Unilateral Band-and-Loop Space Maintainer | Children aged 6-10 years with premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer. Chewing pattern and chewing performance will be assessed before space maintainer placement and again four weeks after placement. Receives: Device: Band-and-Loop Space Maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Masticatory Performance
Change in masticatory performance from before space maintainer placement to 4 weeks after placement, assessed using a two-color chewing gum test. After 20 chewing cycles, color mixing will be scored using the Orophys Subjective Assessment Scale from SA1 to SA5, with higher scores indicating more complete color mixing and better masticatory performance.
Measured: Baseline and 4 weeks after space maintainer placement
Change in Chewing Pattern
Change in chewing pattern from before space maintainer placement to 4 weeks after placement. The dominant chewing side (right/left) will be observed during seven standardized chewing trials. Children using the same side in at least four of seven trials will be classified as unilateral chewers; those showing side alternation will be classified as bilateral chewers.
Measured: Baseline and 4 weeks after space maintainer placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Loss of Primary MolarsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828158
- Sponsor's protocol ID
- chewing.p
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Chewing Pattern in Children Before and After Space Maintainer Placement
- ClinicalTrials.gov ID
- NCT07828158
- Acronym / sponsor ID
- chewing.p
- Conditions
- Premature Loss of Primary Molars
- Keywords
- Space Maintainer, Chewing Pattern, Two-Color Chewing Gum Test, Pediatric Dentistry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Sep 2026 (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.
This prospective observational study aims to evaluate changes in chewing patterns and chewing performance in children before and after placement of a unilateral fixed band-and-loop space maintainer. Children aged 6-10 years who require a space maintainer as part of routine clinical care will be evaluated before appliance placement and again four weeks after placement. Chewing pattern will be assessed by observing the preferred chewing side during standardized chewing trials, and chewing performance will be evaluated using a two-color chewing gum test scored with the Orophys Subjective Assessment Scale. No additional invasive procedure will be performed for research purposes; the space maintainer treatment will be provided as part of routine clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children Receiving a Unilateral Band-and-Loop Space Maintainer | – | Device: Band-and-Loop Space MaintainerChildren aged 6-10 years with premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer. Chewing pattern and chewing performance will be assessed before space maintainer placement and again four weeks after placement. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- Children aged 6-10 years attending the Department of Pediatric Dentistry at Marmara University Faculty of Dentistry who have premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer. Eligible children will be recruited prospectively from patients scheduled to receive space maintainer treatment as part of routine clinical care.
Key inclusion criteria (6 listed)
- Children aged 6-10 years
- Premature loss or extraction of a primary molar in the maxilla or mandible with a clinical indication for a unilateral fixed band-and-loop space maintainer
- The abutment tooth for the space maintainer is vital and either sound or appropriately restored
- Complete dentition on the contralateral side of the arch to allow reliable assessment of chewing function
- No systemic condition affecting chewing function
Key exclusion criteria (7 listed)
- Severe developmental delay, severe behavioral problems, or neuromuscular disorders that may directly affect chewing function, muscle activity, or treatment cooperation
- Temporomandibular joint disorder
- Current orthodontic treatment
- Anterior or posterior crossbite, open bite, or other skeletal or dental malocclusions that may affect chewing function
- Additional missing teeth in the contralateral arch, including hypodontia
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 MaintainerA unilateral fixed band-and-loop space maintainer will be placed as part of routine clinical care following premature loss of a primary molar. The appliance will be cemented to the abutment tooth with glass ionomer cement, and occlusion will be checked after placement. The space maintainer is not assigned for research purposes; it is clinically indicated before study enrollment. | Device | Children Receiving a Unilateral Band-and-Loop Space Maintainer |
Primary outcome
Change in Masticatory Performance
Time frame: Baseline and 4 weeks after space maintainer placement
Change in masticatory performance from before space maintainer placement to 4 weeks after placement, assessed using a two-color chewing gum test. After 20 chewing cycles, color mixing will be scored using the Orophys Subjective Assessment Scale from SA1 to SA5, with higher scores indicating more complete color mixing and better masticatory performance.
Change in Chewing Pattern
Time frame: Baseline and 4 weeks after space maintainer placement
Change in chewing pattern from before space maintainer placement to 4 weeks after placement. The dominant chewing side (right/left) will be observed during seven standardized chewing trials. Children using the same side in at least four of seven trials will be classified as unilateral chewers; those showing side alternation will be classified as bilateral chewers.
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 21 Sep 2026.
- 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?
An observational study of Premature Loss of Primary Molars, run by Marmara 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 21 Sep 2026. 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 afra savas (90 5343279274, aafranursavas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Masticatory Performance (time frame: Baseline and 4 weeks after space maintainer placement). The study lists 2 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 21 Sep 2026.