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?

The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever participants' dentist typically does to help participants manage their fear). The dental fear intervention has 2 separate steps. Step 1 (the less intensive or 'light touch' intervention step) involves using a mobile application (app). Step 2 consists of a one-hour telehealth session with a mental health provider tailored to individualized dental fear. This is a randomized study. The time spent participating in the study will depend on which study condition(s) participants are randomly assigned to. Because this study compares the dental fear intervention to the standard approach, 25% of participants will not get the intervention during the study period. These participants (called controls) will be offered the opportunity to provide feedback about their experiences with dentists. Participants will be offered the intervention free of charge at the conclusion of the study. For each step of the intervention (Dental FearLess app or one-on-one session) relative to treatment as usual, the investigators hypothesize that participants will show greater declines in self-reported dental fear and improved oral health-related quality of life at post-treatment and follow-up period. De-identified attendance records will be collected from dental practices.

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.

Is the Dental FearLess app safe for humans?

The research does not provide specific safety data for the Dental FearLess app, but similar mobile apps for reducing dental anxiety in children have been developed and tested without reported safety issues. ^{1 2 3 4 5}

How does the Dental FearLess treatment differ from other treatments for dental phobia?

The Dental FearLess treatment is unique because it uses a smartphone app to deliver exposure therapy, which involves gradually facing fear-inducing situations, making it more accessible and convenient compared to traditional in-person therapies or medications. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment 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 anxiety levels in children before dental visits, and another study demonstrated that a computerized tool reduced dental anxiety and fear in adults. ^{1 2 8 9 10}

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

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Computerized Tool to Manage Dental Anxiety: A Randomized Clinical Trial. [2018]

2. England 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Are Technology-Based Interventions Effective in Reducing Dental Anxiety in Children and Adults? A Systematic Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Novel Mobile App Intervention to Reduce Dental Anxiety in Infant Patients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Smartphone-based exposure treatment for dental phobia: a pilot randomized clinical trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Methods Helping Dentists to Detect Dental Fear. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

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

8. Italy pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Dental anxiety--the development of a measurement model. [2019]

10. England pubmed.ncbi.nlm.nih.gov

The management of dental anxiety: time for a sense of proportion? [2022]