Dental FearLess for Dental Phobia

Overseen By Kelly Daly, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: New York University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with dental phobia by testing a new two-part intervention called Dental FearLess against the usual fear management techniques used by dentists. The first part uses a mobile app to provide tips and strategies for managing anxiety, while the second part offers a one-hour telehealth session with a mental health provider. Participants will be randomly assigned to either try the new approach or continue with their usual dental fear management. Those with a strong fear of the dentist (a score of 4 or above on a specific fear scale) and access to a smartphone or tablet might be a good fit for this trial. Participants in the control group will have the chance to try the intervention for free after the study. As an unphased trial, this study offers a unique opportunity to explore innovative solutions for dental anxiety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the study focuses on dental fear interventions.

What prior data suggests that the Dental FearLess app is safe for managing dental fear?

Research shows that the Dental FearLess app is safe for users. In a small study, 48 people with moderate to severe dental fear used the app, and none reported major side effects. The app uses cognitive-behavioral therapy (CBT), a well-known and safe method for managing anxiety. It educates users about anxiety and provides strategies to handle fear.

The one-on-one telehealth session is another part of the program. Although specific safety data for these sessions is unavailable, telehealth with mental health professionals is generally safe and well-received. It is often used for various conditions, including anxiety.

Overall, research indicates that both parts of the Dental FearLess program are safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for dental phobia, which often includes therapy sessions or medication, the Dental FearLess app offers a unique e-health solution. This app provides psychoeducation about anxiety and equips users with strategies to manage their fears directly at the dentist's office. Researchers are excited because this digital approach could make anxiety management more accessible and convenient, potentially reducing the need for more intensive treatments.

What evidence suggests that the Dental FearLess intervention is effective for reducing dental fear?

Research has shown that mobile apps and computerized tools like Dental FearLess, which participants in this trial may use, can effectively reduce dental anxiety. One study found that using a mobile app significantly lowered dental fear in participants. In a small study of Dental FearLess, 48 people with moderate to severe dental fear used the app, and many reported feeling less anxious. The app employs a step-by-step method called cognitive behavioral therapy (CBT) to help people manage their fears by changing their thoughts and behaviors. Additionally, those who had a one-on-one session with a mental health provider showed even more improvement. These findings suggest that Dental FearLess could be a promising tool for reducing dental anxiety and improving dental visits. ^{2 3 4 5 6}

Who Is on the Research Team?

Richard Heyman, Ph.D

Principal Investigator

New York University

Mark Wolff, DDS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 with dental fear, as measured by a specific fear rating scale. Participants must be willing to follow study procedures, have access to a smartphone or tablet, and allow their dental attendance records to be accessed.

Inclusion Criteria

You have a high level of fear or anxiety related to dental procedures, scoring 4 or above on a fear rating scale.

I am willing and able to follow all study rules and attend all appointments.

Provide signed and dated informed consent form

Exclusion Criteria

Given the scope and nature of the study, there is no exclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Step 1: Dental FearLess App

Participants use the Dental FearLess app, which includes psychoeducation about anxiety and strategies for coping at the dentist

Up to 8 weeks

Step 2: Telehealth Session

Participants have a one-hour telehealth session with a mental health provider tailored to individualized dental fear

1 session

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 5/6 month follow-up visit

5/6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dental FearLess

Trial Overview The study compares a new two-step intervention called Dental FearLess against the usual care for managing dental fear. The first step uses an app; the second involves telehealth sessions with mental health providers. Some participants will not receive this intervention during the study but can try it afterward.

How Is the Trial Designed?

Group I: Dental FearLess App Experimental Treatment 1 Intervention

Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.

Group II: Treatment as Usual Active Control 1 Intervention

Dental FearLess is already approved in United States for the following indications:

Approved in United States as Dental FearLess for:

• Dental fear
• Dental anxiety

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

The mobile app 'Hello, Dentist!' effectively reduced dental anxiety in children aged 6-10, with statistically significant lower anxiety levels compared to control groups (p < 0.05).

The app was particularly effective for children with higher initial anxiety levels, especially in dental settings, indicating its potential as a valuable tool for managing dental fear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Mobile App Intervention to Reduce Dental Anxiety in Infant Patients. Coutinho, MB., Damasceno, JX., Cals de Oliveira, PCM., et al.[2021]

A systematic review of seven randomized controlled trials found that technology-based interventions, such as video modeling and virtual reality exposure therapy, significantly reduced dental anxiety in both children and adults compared to inactive controls.

Despite the promising results, the overall quality of the studies was low, with many at high risk of bias, indicating a need for more rigorous research to confirm the effectiveness of these interventions in managing dental anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Technology-Based Interventions Effective in Reducing Dental Anxiety in Children and Adults? A Systematic Review. Gujjar, KR., van Wijk, A., Kumar, R., et al.[2022]

A new measurement tool for dental anxiety was tested on 452 participants, revealing two distinct types of phobias: 'generalized' phobias and 'dental specific' phobias, indicating that dental fears are relatively independent from other types of anxiety.

The study developed four reliable scales to assess different anxiety symptoms, which can help differentiate between patients experiencing panic attacks and those who do not, suggesting a more nuanced understanding of anxiety in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental anxiety--the development of a measurement model. Weiner, AA., Sheehan, DV., Jones, KJ.[2019]

A significant portion of patients (10.6%) reported severe dental fear, and the new colour-coded 'traffic light' system effectively identified this fear, with 87% of those with severe fear choosing the red color.

There was a weak correlation between dentists' assessments of dental fear and patients' self-reports, indicating that dentists may struggle to recognize dental fear in their patients, which was further complicated by the impact of COVID-19 on dental attendance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods Helping Dentists to Detect Dental Fear. Kankaala, T., Rajavaara, P., Kestilä, M., et al.[2023]

Dental anxiety and phobia are common issues that can lead to avoidance of dental care, making it crucial for dentists to identify and address these concerns early through subjective evaluations and objective assessments of physiological responses.

Management of dental anxiety can involve a combination of psychotherapeutic interventions, like cognitive behavior therapy, and pharmacological options such as sedation or general anesthesia, tailored to the patient's anxiety level and willingness to engage in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to manage patients with dental anxiety and dental phobia: literature review. Appukuttan, DP.[2022]

A study involving 36 patients with high dental anxiety showed that those who used a smartphone app for self-directed exposure therapy found it highly acceptable and used it about 1.6 times daily.

Participants who engaged in the smartphone exposure therapy reported lower anxiety levels and showed decreased physiological responses, indicating that this method could be an effective way to help people manage dental fear and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based exposure treatment for dental phobia: a pilot randomized clinical trial. Arias, MC., McNeil, DW.[2023]

The study found that 6.3% of children aged 5-10 years in India experience dental anxiety, with the highest prevalence in 5-year-olds at 7.9%, indicating a significant concern for pediatric dental care.

Common triggers for dental anxiety included the sight of injections, dental drilling, and the noise associated with dental procedures, highlighting the need for targeted interventions to alleviate these fears and improve children's oral health experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of dental anxiety and fear among five to ten year old children: a behaviour based cross sectional study. Chhabra, N., Chhabra, A., Walia, G.[2022]

Dental anxiety and fear are widespread issues that can hinder patients from seeking necessary dental treatment, affecting both their health and the efficiency of dental care providers.

Effective management of dental anxiety requires a tailored approach that includes assessing the level of anxiety and implementing appropriate interventions to help patients feel more comfortable during dental visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of dental anxiety: time for a sense of proportion? Newton, T., Asimakopoulou, K., Daly, B., et al.[2022]

A computerized cognitive-behavioral therapy intervention was developed and tested in a randomized controlled trial with 151 adult dental patients, showing significant reductions in dental anxiety and phobia for those who received immediate treatment compared to a wait-list control group.

At the 1-month follow-up, fewer patients in the immediate treatment group continued to meet the criteria for dental phobia, indicating that this intervention could effectively enhance patients' comfort and willingness to seek dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Tool to Manage Dental Anxiety: A Randomized Clinical Trial. Tellez, M., Potter, CM., Kinner, DG., et al.[2018]

Among 55 intra-oral injection-phobic patients, self-perceived oral health was found to be comparable to the general population, with 40% rating their oral health as 'good' or 'very good'.

Cognitive behavioral therapy (CBT) effectively improved patients' positive thoughts and reduced negative thoughts, particularly in those with poorer oral health, but their ability to receive dental injections post-treatment was not affected by their oral health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral health and its influence on cognitive behavioral therapy in patients fulfilling the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for intra-oral injection phobia. Agdal, ML., Raadal, M., Skaret, E., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11173353/

An Uncontrolled Pilot Study - PMC U.S. and global estimates indicate that over 30% of adults fear receiving dental care, including over 20% who have visited a dentist in the last ...

2. dental-tribune.com dental-tribune.com/news/conquering-dental-fear-through-use-of-a-mobile-app/

Conquering dental fear through use of a mobile app The study found that the app offered a stepped-care approach to the cognitive behavioural therapy (CBT) of dental fear that could have a ...

3. withpower.com withpower.com/trial/dental-fearless-for-dental-phobia-08927

Dental FearLess for Dental Phobia Research shows that mobile apps and computerized tools can effectively reduce dental anxiety. For example, a study found that a mobile app significantly lowered ...

4. nyu.edu nyu.edu/about/news-publications/news/2024/february/dental-fear.html

Overcoming Dental Fear with the Tap of an App In a pilot study of Dental Fearless, 48 participants with moderate to severe dental fear used the app, and a subset also completed a one-on-one ...

5. dentalfearless.org dentalfearless.org/

Dental FearLess | dental fear A research study testing a dental fear treatment you can do from home. Contact us for more information.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11633963/

Afraid of the dentist? There's an app for that - PubMed Central Dental FearLess is a mental health-based mobile app that packages the active ingredients of CBT for dental fear (psychoeducation; cognitive, ...