Efficacy of an Internet-based Intervention for Dental Anxiety
NCT ID: NCT03680755
Last Updated: 2025-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
503 participants
INTERVENTIONAL
2019-07-24
2024-10-03
Brief Summary
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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.
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Detailed Description
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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. Efficacy will be indexed by measures of dental anxiety and fear completed at 1-month and 3-month follow-up assessments.
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. Efficacy will be indexed by measures of dental anxiety and fear completed at 1-month and 3-month follow-up assessments.
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.
Patients (N=450) between the ages of 18 and 75 attending the Temple University Kornberg School of Dentistry (TUKSoD) dental clinics and reporting high dental anxiety that causes at least mild impairment will be recruited and consented. To obtain the sample, the investigators will screen all patients who present to the Faculty Practice Clinic (FPC) of TUKSoD (as well as the Graduate Clinics of TUKSoD \[Endodontology, Periodontology, Advanced Education General Dentistry\], if necessary). Total participation time for each patient is approximately 4 months but could be slightly longer pending the interval between screening/baseline and the scheduled date of the dental anxiety intervention/dental appointment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tr1 group
Participants assigned to Tr1 will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.
Internet-based intervention for dental anxiety
Participants will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments or by dental staff. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.
Tr2 group
Participants assigned to Tr2 will complete the experimental dental anxiety management program, which will be facilitated by dental staff. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.
Internet-based intervention for dental anxiety
Participants will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments or by dental staff. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.
Active control
Participants assigned to the control group, will not complete the experimental dental anxiety management program at this time. They will complete study paperwork and watch a non-dental video for 45 minutes before their scheduled dental appointment. Immediately after the dental appointment, they will complete a brief interview with the research staff person.
No interventions assigned to this group
Interventions
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Internet-based intervention for dental anxiety
Participants will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments or by dental staff. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Temple University
OTHER
Responsible Party
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Principal Investigators
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Marisol Tellez Merchan, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor
Eugene M Dunne, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor
Locations
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Maurice H Kornberg School of Dentistry Temple University
Philadelphia, Pennsylvania, United States
Countries
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References
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Humphris GM, Morrison T, Lindsay SJ. The Modified Dental Anxiety Scale: validation and United Kingdom norms. Community Dent Health. 1995 Sep;12(3):143-50.
Brahm CO, Lundgren J, Carlsson SG, Nilsson P, Corbeil J, Hagglin C. Dentists' views on fearful patients. Problems and promises. Swed Dent J. 2012;36(2):79-89.
Farrar JT, Polomano RC, Berlin JA, Strom BL. A comparison of change in the 0-10 numeric rating scale to a pain relief scale and global medication performance scale in a short-term clinical trial of breakthrough pain intensity. Anesthesiology. 2010 Jun;112(6):1464-72. doi: 10.1097/ALN.0b013e3181de0e6d.
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
Gordon D, Heimberg RG, Tellez M, Ismail AI. A critical review of approaches to the treatment of dental anxiety in adults. J Anxiety Disord. 2013 May;27(4):365-78. doi: 10.1016/j.janxdis.2013.04.002. Epub 2013 Apr 13.
Tellez M, Potter CM, Kinner DG, Jensen D, Waldron E, Heimberg RG, Myers Virtue S, Zhao H, Ismail AI. Computerized Tool to Manage Dental Anxiety: A Randomized Clinical Trial. J Dent Res. 2015 Sep;94(9 Suppl):174S-80S. doi: 10.1177/0022034515598134. Epub 2015 Jul 22.
Gross PR. Is pain sensitivity associated with dental avoidance? Behav Res Ther. 1992 Jan;30(1):7-13. doi: 10.1016/0005-7967(92)90090-4.
Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-report measure. Motivation and Emotion, 29(2), 83-102. http://dx.doi.org/10.1007/s11031-005-7955-3
Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. doi: 10.1016/0005-7967(79)90041-x. No abstract available.
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
Potter CM, Jensen D, Kinner D, Tellez M, Ismail AI, Heimberg RG. Single-session computerized cognitive behavioral therapy for dental anxiety: A case series. Clinical Case Studies. 2016;15(1):3-17.
Tellez M, Dunne EM, Konneker E, Zhao H, Ismail AI. Online Cognitive-Behavioural Intervention to Manage Dental Anxiety: A 12-Month Randomised Clinical Trial. Community Dent Oral Epidemiol. 2025 Oct;53(5):543-555. doi: 10.1111/cdoe.13049. Epub 2025 Jun 13.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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