N/A
N=499
Efficacy of an Internet-based Intervention for Dental Anxiety
Dental Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03680755 ↗Enrolled (actual)
499
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). — 19.8; 19.4; 19.4; 16.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Internet-based intervention for dental anxiety (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Temple University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). |
19.8; 19.4; 19.4; 16.7; 17.2; 18 | — |
| PRIMARY Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) |
5.2; 5.4; 5.4; 4.8; 4.7; 4.8 | — |
| SECONDARY Change in Avoidance Rating From the ADIS-5 |
4.7; 4.7; 4.7; 3.9; 3.9; 3.8 | — |
| SECONDARY Pain Intensity Numeric Rating Scale (PI-NRS). |
21; 16; 12; 8; 10; 4 | — |
| SECONDARY Pain Sensitivity Index (PSI; Gross, 1992a). |
67.3; 68.4; 68.4; 58.6; 63.2; 62.8 | — |
| SECONDARY Distress Tolerance Scale (DTS; Simons & Gaher, 2005). |
45.6; 44.9; 43.7; 47.6; 46.3; 46.1 | — |
| SECONDARY Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). |
45.6; 44.9; 43.7; 47.6; 46.3; 46.1 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). |
27.3; 27.7; 25.9; 26.8; 26.4; 27.4 | — |
| SECONDARY Change in Distress and Interference Rating From the ADIS-5 |
4.6; 4.5; 4.3; 4.0; 3.9; 3.7 | — |
| SECONDARY Change in Percentage of Dentally Phobic Patients From the ADIS-5 |
131; 130; 140; 72; 73; 84 | — |
| SECONDARY Change in Attendance at Dental Appointments |
0.6; 0.6; 0.7; 6.2; 5.7; 6.2 | — |
Summary
The overall objective of the activities described in this protocol is to examine the efficacy of the Internet-based intervention in the reduction of dental anxiety in patients seeking dental treatment. This study has 2 primary objectives and 2 secondary objectives:
Primary Objective 1-Therapy Aides: To compare the efficacy of the intervention as administered by personnel with training and experience in cognitive behavioral therapy (CBT) to the efficacy of the intervention as administered by dental staff who have undergone a brief but specific training in the administration of the intervention.
Primary Objective 2-Intervention Efficacy: To compare the efficacy of the intervention, administered by either type of therapy aide (CBT personnel or dental staff), to an active control condition.
Secondary Objective 1-Tests of Moderators: To examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the dental anxiety intervention, regardless of therapy aide, in comparison to an active control condition.
Secondary Objective 2-Other Intervention Effects: To explore effects of the intervention beyond primary efficacy, including attendance at recall visits in the 12 months after the intervention; pain intensity; avoidance due to fear of dental procedures; and client satisfaction.
Eligibility Criteria
Inclusion Criteria
- patient endorses high dental anxiety (a score of 19 or a score of 4-5 on at least 2 of the 5 items) on the MDAS
- endorses at least mild impairment as a result of that anxiety at the baseline interview as indexed by the appropriate rating in the specific phobia module of the ADIS-5
- be between 18 and 75 years of age
- be sufficiently fluent in written and spoken English in the judgment of project staff that the patient would be able to benefit from the intervention and validly complete the assessments.
Exclusion Criteria
- a self-reported current medical condition (e.g., cardiopulmonary disease, seizure disorder) that might make exposure to anxiety-evoking stimuli inadvisable
- current suicidal/homicidal ideation/intent or other condition that would take priority over an intervention focused on dental anxiety
- current psychosis, mental retardation, or other condition that would significantly diminish the patient's ability to adequately focus attention adaptively on the current protocol
- inability to give informed consent.
Data sourced from ClinicalTrials.gov (NCT03680755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.