Premature Loss of Primary MolarsNCT07410442
Clinical Safety Guidelines for Managing Distal Shoe Complications
An observational study of Premature Loss of Primary Molars and Space Maintainer, run by University of Florida at 2 sites in United States.
Trial summary
Distal shoe space maintainers are the standard of care for guiding the eruption of permanent first molars following the premature loss of the primary second molars. Although this therapy represents established clinical practice, prospective evidence regarding soft tissue complications and predictors of treatment… Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Premature Loss of Primary Molars, Space Maintainer, Soft Tissue Inflammation
- What is being tested?
- Standard Clinical Practice Regimen
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2026to Feb 2029
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of pediatric patients recruited from the University of Florida College of Dentistry Pediatric Dental Clinic. Participants are children aged 3 to 9 years, classified as ASA I or II, who require distal shoe therapy as part of their standard clinical care following premature loss of a primary second molar. This population represents a clinical sample of children undergoing established space maintenance procedures under general anesthesia due to behavioral or clinical necessity.
Who may be able to join
- Pediatric participants aged 3 to 9 years
- American Society of Anesthesiologists (ASA) Physical Status I or II
- Clinical indication for distal shoe therapy as the standard of care
- Undergoing distal shoe space maintainer placement
- Parent or caregiver able to provide consent and comply with follow-up visits
Who cannot join
- Presence of systemic medical conditions that may affect bone metabolism or wound healing
- Patients unable or unwilling to comply with the planned follow-up schedule (up to 24 months)
- Patients with contraindications to distal shoe therapy based on clinical judgment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Department of Pediatric Dentistry, Universit of Florida, College of Dentistry
Gainesville, Florida, 32610
Mi Sook Lee, DMD, MSD, PhD, 352-273-7643, misooklee@ufl.edu
Marcio Guelmann, DDS, 352-273-7635, mguelmann@dental.ufl.edu
- Recruiting
University of Florida
Gainesville, Florida, 32610
About this study
Official title: Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study
Distal shoe space maintainers are the standard of care for guiding the eruption of permanent first molars following the premature loss of the primary second molars. Although this therapy represents established clinical practice, prospective evidence regarding soft tissue complications and predictors of treatment outcomes remains limited. This observational study will prospectively collect clinical outcome data during routine treatment visits. The aims of the study are to characterize patterns of complications, evaluate outcomes related to patient adherence, and identify predictors of treatment success. Ultimately, this study seeks to support the development of standardized strategies for clinical monitoring and complication management.
Read the detailed description
The premature loss of a primary second molar prior to the eruption of the permanent first molar represents a significant clinical challenge in pediatric dentistry. Without appropriate intervention, the unerupted permanent first molar invariably drifts mesially during its eruptive path, resulting in severe arch length deficiency, impaction of the permanent second premolar, and complex malocclusions. The distal shoe space maintainer is the definitive intervention for these cases; its subgingival guide plane acts as a critical buttress, directing the permanent first molar into its correct anatomical position.
Despite its status as a standard clinical procedure, standardized clinical monitoring protocols and evidence-based complication management strategies remain limited. Current literature is primarily restricted to case reports and small retrospective series characterized by substantial heterogeneity in appliance design, follow-up intervals, and criteria for clinical success. Consequently, existing data offer descriptive or anecdotal observations rather than robust, prospective evidence. This gap in the literature leaves several critical clinical concerns unresolved:
Histological and Soft Tissue Ambiguity: Because the appliance's distal extension penetrates the gingival epithelium, it creates a potential pathway for bacterial ingress. There is a significant dearth of prospective data regarding long-term gingival health, the nature of the epithelial attachment, and the chronic inflammatory response at the subgingival metal interface.
Non-Standardized Complication Management: Clinicians currently lack a universal framework or validated assessment tool for managing prevalent complications, such as localized gingival inflammation, ulceration, appliance fracture, or cement failure.
Uncertain Predictors of Success: In the absence of systematic longitudinal monitoring, it remains difficult to quantify how patient-specific variables-specifically oral hygiene adherence and individual gingival reactivity-influence overall treatment success and post-operative morbidity.
Therefore, this prospective study is essential to systematically investigate soft tissue responses and complication patterns. By documenting these outcomes through standardized follow-up and data collection protocols, this research aims to establish evidence-based clinical guidelines and a decision-making framework to optimize treatment outcomes and minimize patient morbidity.
- Being tested
- Standard Clinical Practice Regimen
- Keywords
- primary second molar, distal shoe, soft tissue complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Clinical Practice RegimenOther
his study involves the prospective observational monitoring of clinical outcomes during standard distal shoe therapy. Research activities consist of systematic documentation of clinical data, including radiographic assessment of the intra-alveolar blade depth measured from the mesial margin of the permanent first molar, standardized gingival health scores, and caregiver-reported compliance. No experimental modifications to the clinical device or surgical procedures are performed, ensuring the study reflects routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Distal Shoe Therapy Cohort | This cohort includes pediatric patients, aged 3 to 9 years (ASA I or II), for whom distal shoe therapy has been clinically indicated as the standard of care (SOC). Participants undergo routine appliance fabrication and placement as part of their standard clinical care. The cohort will be prospectively monitored during SOC follow-up visits (at 1-week and 3-month intervals) to evaluate soft tissue health, gingival inflammation, and the successful eruption of the permanent first molar. Individual participation typically ranges from 12 to 24 months. Receives: Other: Standard Clinical Practice Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of soft tissue complications adjacent to the distal shoe appliance
Assessment of the proportion of participants experiencing localized soft tissue complications and the graded severity of such responses. Evaluation includes the presence of gingival inflammation, ulceration, granulation tissue formation, or clinical signs of infection. These complications will be systematically documented during standardized clinical examinations at each follow-up visit. Severity will be categorized using a defined clinical scale (none, mild, moderate, severe). For participants with multiple symptoms, the overall severity will be reported based on the most severe clinical finding to arrive at one aggregated value per participant.
Measured: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).
Secondary outcomes (3)
Frequency of missed follow-up appointments per participant
Assessment of patient and caregiver compliance through the systematic tracking of scheduled routine follow-up visits. This measure quantifies the total number of missed appointments during the study period for each participant, reflecting adherence to the prescribed clinical monitoring protocol.
Measured: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).
Adherence to oral hygiene instructions based on clinical assessment
Evaluation of patient/caregiver adherence to standardized oral hygiene protocols. Adherence will be assessed during routine follow-up visits and reported as the number of participants who consistently maintain adequate oral hygiene (e.g., meeting predefined clinical criteria for plaque control) throughout the study duration.
Measured: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).
Incidence of successful eruption guidance of the permanent first molar
The success of eruption guidance will be determined by verifying the correct anatomical positioning of the permanent first molar. Success is defined by radiographic assessment (bitewing radiographs) and standardized clinical photographs showing the molar in its intended position without impaction or significant mesial drifting. Results will be reported as the number of participants achieving successful eruption guidance.
Measured: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Loss of Primary MolarsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mi Sook Lee, DMD, MSD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410442
- Sponsor's protocol ID
- IRB202600105
- Status last verified
- Jul 2026
- First submitted
- 7 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared to ensure the protection of patient privacy and maintain strict adherence to HIPAA regulations. The research involves sensitive clinical and radiographic data of pediatric participants, which is stored in a secure, encrypted database accessible only to the approved research team. While de-identified aggregate data will be used for publications and presentations, the raw individual-level data is restricted to maintain the highest level of research data integrity and confidentiality.
Publications
Brill WA. The distal shoe space maintainer chairside fabrication and clinical performance. Pediatr Dent. 2002 Nov-Dec;24(6):561-5.
PubMed 12528949
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT07410442
- Acronym / sponsor ID
- IRB202600105
- Keywords
- primary second molar, distal shoe, soft tissue complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 13 Feb 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.
Distal shoe space maintainers are the standard of care for guiding the eruption of permanent first molars following the premature loss of the primary second molars. Although this therapy represents established clinical practice, prospective evidence regarding soft tissue complications and predictors of treatment outcomes remains limited. This observational study will prospectively collect clinical outcome data during routine treatment visits. The aims of the study are to characterize patterns of complications, evaluate outcomes related to patient adherence, and identify predictors of treatment success. Ultimately, this study seeks to support the development of standardized strategies for clinical monitoring and complication management.
Detailed description
The premature loss of a primary second molar prior to the eruption of the permanent first molar represents a significant clinical challenge in pediatric dentistry. Without appropriate intervention, the unerupted permanent first molar invariably drifts mesially during its eruptive path, resulting in severe arch length deficiency, impaction of the permanent second premolar, and complex malocclusions. The distal shoe space maintainer is the definitive intervention for these cases; its subgingival guide plane acts as a critical buttress, directing the permanent first molar into its correct anatomical position.
Despite its status as a standard clinical procedure, standardized clinical monitoring protocols and evidence-based complication management strategies remain limited. Current literature is primarily restricted to case reports and small retrospective series characterized by substantial heterogeneity in appliance design, follow-up intervals, and criteria for clinical success. Consequently, existing data offer descriptive or anecdotal observations rather than robust, prospective evidence. This gap in the literature leaves several critical clinical concerns unresolved:
Histological and Soft Tissue Ambiguity: Because the appliance's distal extension penetrates the gingival epithelium, it creates a potential pathway for bacterial ingress. There is a significant dearth of prospective data regarding long-term gingival health, the nature of the epithelial attachment, and the chronic inflammatory response at the subgingival metal interface.
Non-Standardized Complication Management: Clinicians currently lack a universal framework or validated assessment tool for managing prevalent complications, such as localized gingival inflammation, ulceration, appliance fracture, or cement failure.
Uncertain Predictors of Success: In the absence of systematic longitudinal monitoring, it remains difficult to quantify how patient-specific variables-specifically oral hygiene adherence and individual gingival reactivity-influence overall treatment success and post-operative morbidity.
Therefore, this prospective study is essential to systematically investigate soft tissue responses and complication patterns. By documenting these outcomes through standardized follow-up and data collection protocols, this research aims to establish evidence-based clinical guidelines and a decision-making framework to optimize treatment outcomes and minimize patient morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal Shoe Therapy Cohort | – | Other: Standard Clinical Practice RegimenThis cohort includes pediatric patients, aged 3 to 9 years (ASA I or II), for whom distal shoe therapy has been clinically indicated as the standard of care (SOC). Participants undergo routine appliance fabrication and placement as part of their standard clinical care. The cohort will be prospectively monitored during SOC follow-up visits (at 1-week and 3-month intervals) to evaluate soft tissue health, gingival inflammation, and the successful eruption of the permanent first molar. Individual participation typically ranges from 12 to 24 months. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of pediatric patients recruited from the University of Florida College of Dentistry Pediatric Dental Clinic. Participants are children aged 3 to 9 years, classified as ASA I or II, who require distal shoe therapy as part of their standard clinical care following premature loss of a primary second molar. This population represents a clinical sample of children undergoing established space maintenance procedures under general anesthesia due to behavioral or clinical necessity.
Key inclusion criteria (5 listed)
- Pediatric participants aged 3 to 9 years
- American Society of Anesthesiologists (ASA) Physical Status I or II
- Clinical indication for distal shoe therapy as the standard of care
- Undergoing distal shoe space maintainer placement
- Parent or caregiver able to provide consent and comply with follow-up visits
Key exclusion criteria (3 listed)
- Presence of systemic medical conditions that may affect bone metabolism or wound healing
- Patients unable or unwilling to comply with the planned follow-up schedule (up to 24 months)
- Patients with contraindications to distal shoe therapy based on clinical judgment
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 |
|---|---|---|
| Standard Clinical Practice Regimenhis study involves the prospective observational monitoring of clinical outcomes during standard distal shoe therapy. Research activities consist of systematic documentation of clinical data, including radiographic assessment of the intra-alveolar blade depth measured from the mesial margin of the permanent first molar, standardized gingival health scores, and caregiver-reported compliance. No experimental modifications to the clinical device or surgical procedures are performed, ensuring the study reflects routine clinical practice. | Other | Distal Shoe Therapy Cohort |
Primary outcome
Incidence and severity of soft tissue complications adjacent to the distal shoe appliance
Time frame: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).
Assessment of the proportion of participants experiencing localized soft tissue complications and the graded severity of such responses. Evaluation includes the presence of gingival inflammation, ulceration, granulation tissue formation, or clinical signs of infection. These complications will be systematically documented during standardized clinical examinations at each follow-up visit. Severity will be categorized using a defined clinical scale (none, mild, moderate, severe). For participants with multiple symptoms, the overall severity will be reported based on the most severe clinical finding to arrive at one aggregated value per participant.
3 secondary outcomes
Frequency of missed follow-up appointments per participant
Time frame: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).
Adherence to oral hygiene instructions based on clinical assessment
Time frame: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).
Incidence of successful eruption guidance of the permanent first molar
Time frame: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).
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 6 Jul 2026.
- Background: PubMed 12528949Brill WA. The distal shoe space maintainer chairside fabrication and clinical performance. Pediatr Dent. 2002 Nov-Dec;24(6):561-5.
- University of Florida College of Dentistry, Department of Pediatric DentistryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared to ensure the protection of patient privacy and maintain strict adherence to HIPAA regulations. The research involves sensitive clinical and radiographic data of pediatric participants, which is stored in a secure, encrypted database accessible only to the approved research team. While de-identified aggregate data will be used for publications and presentations, the raw individual-level data is restricted to maintain the highest level of research data integrity and confidentiality.
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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.
Mi Sook Lee, DMD, MSD, PhD principal investigator
University of Florida
2 sites 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 and Space Maintainer, run by University of Florida at 2 sites in United States.
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 5 inclusion and 3 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Mi Sook Lee, DMD, MSD, PhD (352-273-7643, misooklee@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of soft tissue complications adjacent to the distal shoe appliance (time frame: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07410442, which also lists 1 linked publication.
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 6 Jul 2026.