NCT07711301

Brief Summary

Study Overview Primary ("baby") teeth are unique biological samples because they can permanently store information about a child's early life health and development. While donating baby teeth to scientific research is painless and simple, researchers often face challenges collecting them. Past studies show that donation rates are particularly low among racial minority groups and lower-income families, even though these populations may experience higher rates of early-life adversity and could benefit greatly from this research. Currently, very little is known about what influences a parent's willingness to donate their child's teeth. This study evaluates whether an educational tool can bridge this gap. Researchers will use a children's book and video called "The Science Tooth Fairy" to see if explaining the importance of tooth donation can positively change parents' attitudes and willingness to participate in scientific research. Study Objectives and Hypotheses The main goal of this research is to investigate parental attitudes toward donating their children's baby teeth and to see if educational materials can encourage participation. The study is testing two main hypotheses:

  • Primary Hypothesis: Parents who interact with "The Science Tooth Fairy" materials (either the book, video, or both) will show a greater positive shift in their attitudes toward tooth donation compared to parents who read a standard oral health book that does not mention research.
  • Secondary Hypothesis: "The Science Tooth Fairy" story's content and delivery format (book, video, or both) influence parental engagement with and understanding of the intervention materials. Study Design and Procedures This is a randomized controlled trial aiming to recruit approximately 120 parents or legal guardians of children aged 4 to 10. Recruitment will take place in diverse clinical spaces (such as pediatric and dental clinics) and public events to ensure a representative sample. The entire study takes about 30 to 45 minutes to complete in a single session. Participants will be randomly assigned to one of four groups:
  • Group 1: Read a printed copy of "The Science Tooth Fairy" book.
  • Group 2: Watch a video version of "The Science Tooth Fairy".
  • Group 3: Watch the video and have the option to read the printed book.
  • Group 4 (Control Group): Read a standard children's book about oral health ("Cavities vs. Toothpaste"), which contains no mention of research or donation.
  • Informed Consent: Reviewing and signing the study consent form.
  • Pre-Assessment Survey: A 14-item questionnaire evaluating current trust in medical research and attitudes toward biological donations.
  • The Intervention: Completing the reading or viewing activity assigned during randomization.
  • Post-Assessment Survey: An identical 14-item questionnaire to measure changes in attitude, along with a background demographics survey. By comparing survey responses before and after the activity, researchers hope to learn how to design future recruitment strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

tooth, deciduoushealth education

Outcome Measures

Primary Outcomes (1)

  • Change in psychosocial construct scores relevant to tooth donation

    To measure primary outcomes we developed a survey by adapting validated psychometric scales assessing psychosocial factors that are relevant to primary tooth donation. The same survey was applied before and after the assigned intervention.

    Thirty minutes before intervention (pre-intervention) and within 30 minutes of completion of the intervention (post-intervention)

Secondary Outcomes (1)

  • Post-intervention psychosocial construct scores relevant to parental engagement with the intervention materials

    Within 30 minutes of intervention completion

Study Arms (4)

STF Book

EXPERIMENTAL

Printed narrative

Behavioral: Science Tooth Fairy Narrative

STF Video

EXPERIMENTAL

Audiovisual adaptation of the book

Behavioral: Science Tooth Fairy Narrative

STF Book + Video

EXPERIMENTAL

Combined exposure

Behavioral: Science Tooth Fairy Narrative

Control

ACTIVE COMPARATOR

Cavities vs. Toothpaste, book by Didi Dragon

Behavioral: Cavities vs. Toothpaste, book by Didi Dragon

Interventions

The STF narrative follows two children, Isabella and Charlie, as they learn about tooth donation, rituals practiced by different cultures, and why and how these teeth are used in the scientific process. Centered on curiosity and respect for child autonomy and traditions, the story concludes with a tear-away page that allows children to correspond with the character and receive a personalized response. Narrative persuasion theory suggests that readers who identify with story characters are more likely to adopt the characters' beliefs and intentions . By following Isabella and Charlie's journey of curiosity, parents and children may indirectly experience the primary tooth donation process, which may enhance self-efficacy and increase the likelihood of participation.

STF BookSTF Book + VideoSTF Video

Cavities vs. Toothpaste by Didi Dragon is a children's book that humorously explains dental hygiene, following the "bad" bacteria in your mouth as they feast on sugar, create "sugapoo" (lactic acid), and form cavities, only to be defeated by toothpaste and proper brushing.

Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Biological or non-biological parents (e.g., legal caregivers or guardians) of children aged 4-10 years

You may not qualify if:

  • Reports feeling uncomfortable reading and listening to materials
  • Prior exposure to the STF book or video.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Revere HealthCare Center and Tufts Pediatric Dental Clinic

Boston, Massachusetts, 02145, United States

Location

Related Publications (1)

  • Davis KA, Mountain RV, Pickett OR, Den Besten PK, Bidlack FB, Dunn EC. Teeth as Potential New Tools to Measure Early-Life Adversity and Subsequent Mental Health Risk: An Interdisciplinary Review and Conceptual Model. Biol Psychiatry. 2020 Mar 15;87(6):502-513. doi: 10.1016/j.biopsych.2019.09.030. Epub 2019 Dec 17.

MeSH Terms

Conditions

BehaviorHealth Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: four-arm, parallel-group randomized controlled superiority trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

September 1, 2022

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect the privacy of the participants. Data sharing is limited to the aggregate results of the study, which will be published in peer-reviewed journals and reported on ClinicalTrials.gov as required.

Locations