Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01901250 · ClinicalTrials.gov registry record · NA
Xylitol for Caries Prevention in Inner-City Children
A NA study of Dental Caries, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 562
- Enrollment target
- 1
- Study location
NCT01901250: Completed NA study of Dental Caries, sponsored by Case Western Reserve University.
NCT01901250 is a NA study of Dental Caries that has completed, run by Case Western Reserve University. The registered enrollment target is 562 participants, below the 703-participant average among 30 other Dental Caries trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01901250, a NA study of Dental Caries, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 562 participants
- Enrollment target
- 1
- Study location
Study Summary
The purposes of this study is to determine whether xylitol use in kindergarten school children in addition to oral health education, provision of tooth brush and fluoride paste, fluoride varnish and sealant treatment will reduce decay in the first permanent molars and other permanent teeth.
Primary Outcome
The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces. For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the "D"
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Xylitol gummy bears
- DIETARY_SUPPLEMENT Sugar free fiber gummy bears
- BEHAVIORAL Oral health education
- DEVICE Fluoride varnish
- DEVICE Dental sealant
Study Locations (1)
Ohio
- Case Western Reserve University - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2007-08 |
| Est. Completion | 2011-12 |
| Phase | NA |
What the finished NCT01901250 record still lists
NCT01901250 is an interventional study that assigns participants to a tested intervention. The registered 562 participants enrollment target is mid-sized for trials with a published cap, below the 703-participant average among 30 other Dental Caries trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 5 interventions - of which Xylitol gummy bears is the first listed.
NCT01901250 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01901250 about?
NCT01901250 is a clinical study titled "Xylitol for Caries Prevention in Inner-City Children". The purposes of this study is to determine whether xylitol use in kindergarten school children in addition to oral health education, provision of tooth brush and fluoride paste, fluoride varnish and sealant treatment will reduce decay in the first permanent molars and other permanent teeth.
What is the current status of trial NCT01901250?
This trial is currently completed. It is a NA study. The enrollment target is 562 participants. The study started on 2007-08. Estimated completion is 2011-12.
What conditions does trial NCT01901250 study?
This clinical trial studies the following conditions: Dental Caries.
What interventions are being tested in trial NCT01901250?
The interventions under investigation include: Xylitol gummy bears (DIETARY_SUPPLEMENT), Sugar free fiber gummy bears (DIETARY_SUPPLEMENT), Oral health education (BEHAVIORAL), Fluoride varnish (DEVICE), Dental sealant (DEVICE).
Who is sponsoring clinical trial NCT01901250?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01901250 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dental Caries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01901250's enrollment target sits among peer trials
562 6th of 30 higher than 25 of 30 other Dental Caries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dental Caries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth
RECRUITING · NA
-
LT Comparative Effectiveness of 2 Caries Treatments
RECRUITING · NA
-
Advancing Water Security: A Community Participatory School-Based Hydration Intervention
RECRUITING · NA
-
Oral Health Intervention in Adult Primary Care
RECRUITING · NA
-
Polymer Induced Liquid Precursor (PILP) in Adults in With Dentin Caries
RECRUITING · NA
-
In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Remineralization
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07007065 · 561 participants · Phase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
- NCT06146725 · 564 participants
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
- NCT06188520 · 564 participants · Phase 1
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
- NCT06628453 · 564 participants · NA
CGM for Management of Type 2 Diabetes in Pregnancy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia