Dental AnxietyNCT03680755
Efficacy of an Internet-based Intervention for Dental Anxiety
A study testing Internet-based intervention for dental anxiety in people with Dental Anxiety, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Internet-based intervention for dental anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2019to 3 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maurice H Kornberg School of Dentistry Temple University
Philadelphia, Pennsylvania, 19140
About this study
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.
Read more
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.
Read the detailed description
This clinical trial will evaluate the efficacy of a brief Internet-based cognitive-behavioral intervention for the treatment of impairing dental anxiety among those seeking dental care at the clinics of a university dental school. The primary objective of human subjects activities described in this protocol is to evaluate the efficacy of the Internet-based intervention for dental anxiety among patients presenting to the participating clinic(s). To achieve this overall objective, 2 primary objectives and 2 secondary objectives have been proposed:
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
- Dental Anxiety
- Being tested
- Internet-based intervention for dental anxiety
- Keywords
- dental avoidance, dental phobia, pain sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based intervention for dental anxietyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tr1 group | Experimental | 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. Receives: Behavioral: Internet-based intervention for dental anxiety |
| Tr2 group | Experimental | 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. Receives: Behavioral: Internet-based intervention for dental anxiety |
| Active control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995).
The MDAS is a widely used 5-item measure assessing fear of dental procedures, including cleaning, drilling, and local anesthetic injections; for example, "If you were about to have your tooth drilled, how would you feel?" Items are rated on a 5-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). The total score ranges from 5 to 25; a score of 19 or above indicates high anxiety based on receiver operating characteristic analyses from previous studies.
Measured: The MDAS will be administered at the baseline assessment and at one- and three-month follow-ups.
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)
The ADIS-5 is a semi-structured interview designed to establish reliable diagnoses of the DSM-5 anxiety, mood, somatoform, and substance use disorders. To minimize participant burden, this study will utilize only the dental procedure-related section of the specific phobia module of the interview. This module includes ratings of fear and avoidance of dental procedures (0 = No fear/Never avoids to 8 = Very severe fear always avoids) as well as resultant interference (0 = None to 8 = Very severe; the latter being used to operationalize one of the inclusion criteria). For the dental phobia diagnosis, a dimensional clinical severity rating (CSR), ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. All interviews will be audio-recorded. The 0-8 rating of dental fear will serve as the primary measure derived from the ADIS-5.
Measured: The ADIS-5 will be administered at the baseline assessment and at one- and three-month follow-ups.
Secondary outcomes (9)
Change in Avoidance Rating From the ADIS-5
The rating of avoidance included in the specific phobia module of the ADIS-5 will be considered a secondary outcome measure. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance.
Measured: baseline assessment, and at one- and three-month follow-ups.
Pain Intensity Numeric Rating Scale (PI-NRS).
The PI-NRS is a widely utilized 11-point self-report measure that assesses physical pain intensity on a scale ranging from 0 (no pain) to 10 (worst possible pain). Anxiety increases subjective pain experience, and therefore this scale will be used to assess the intensity of dental-related pain that participants expect to experience at their dental appointment scheduled after the dental anxiety intervention (or control), the intensity of pain they actually experienced, and the intensity of pain they expect to experience at their next similar dental appointment.
Measured: These ratings will be administered as part of the post-appointment debriefing interview, as well as at the 1-month and 3-month follow-ups.
Pain Sensitivity Index (PSI; Gross, 1992a).
The PSI is a 16-item self-report measure that assesses the fearful appraisal of pain and the expected physical, psychological, and social consequences of pain. Items are rated on a scale ranging from 0 (not at all) to 7 (very much) reflecting the degree to which the item applies to the respondent. Higher scores indicate higher levels of pain sensitivity. The minimum PSI score is 0, while the maximum PSI score is 112.
Measured: It will be administered at baseline and the 1-month and 3-month follow-ups.
Distress Tolerance Scale (DTS; Simons & Gaher, 2005).
The DTS is a 15-item self-report measure assessing one's perceived ability to experience and tolerate negative emotional states. This scale measures four dimensions of distress tolerance: subjective appraisal of distress, ability to tolerate emotional distress, absorption of attention by negative emotions, and regulation efforts to alleviate distress. Items are rated on a scale ranging from 1 (strongly agree) to 5 (strongly disagree). Total score range from 15 to 75, with higher scores reflecting higher levels of distress tolerance.
Measured: The DTS will be administered at the baseline assessment and at one- and three-month follow-ups
Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979).
The FQ-BII is a 5-item subscale of the complete FQ. It assesses the degree to which an individual avoids situations involving blood-injury-injection because of fear, including in the context of dental procedures. Items are rated on a scale ranging from 0 (would not avoid it) to 8 (would always avoid it). Total scores range from 0-40 with higher scores indicating greater phobic avoidance.
Measured: It will be administered at the baseline assessment and at one- and three-month follow-ups.
Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979).
The CSQ-8 is used in the measurement of client/patient assessment of satisfaction with services and clinical care. It consists of 8 items rated on a 1-to-4 scale. Higher scores indicate greater satisfaction with services, with a minimum score of 8 and a maximum score of 32.
Measured: The CSQ-8 will be administered post-intervention (within 48 hours after the participant's dental appointment), as well as at the one- and three-month follow-ups.
Change in Distress and Interference Rating From the ADIS-5
The rating of distress and interference included in the specific phobia module of the ADIS-5 will be considered a secondary outcome measure. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance.
Measured: baseline assessment, and at one- and three-month follow-ups.
Change in Percentage of Dentally Phobic Patients From the ADIS-5
Percentage of patients who meet criteria for a specific phobia of dental procedures at baseline. We will examine whether this percentage decreases as a function of the arm of the study to which patients are assigned.
Measured: baseline assessment, and at one- and three-month follow-ups.
Change in Attendance at Dental Appointments
We will utilize TUKSoD's automated scheduling system (axiUm, http://www.axiumdental.com/) to collect information about dental attendance.
Measured: 1 year post-dental anxiety intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start24 Jul 2019
- Primary completion3 Oct 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a single-center parallel groups study with randomization to one of three arms: (1) a treatment condition (Tr1) in which the dental anxiety intervention is administered by CBT personnel (n=150), (2) a treatment condition in which the dental anxiety intervention is administered by dental staff (Tr2) (n=150), or (3) an active control (AC) group (notification of the dental providers of the patient's score on a dental anxiety scale before their dental treatment appointment). In addition, control participants will be asked to view a video of nature scenes for a period of time equivalent to the dental anxiety intervention.
- Masking
- None (open label)
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Marisol Tellez Merchan, PhD, Principal investigator, ProfessorEugene M Dunne, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680755
- Sponsor's protocol ID
- U01DE027328
- Other IDs
- U01DE027328
- Status last verified
- Jul 2025
- First submitted
- 30 Aug 2018
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7584581Brahm 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.
PubMed 22876395Farrar 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.
PubMed 20463579Farrar 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.
PubMed 11690728Gordon 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.
PubMed 23746494Tellez 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.
PubMed 26202996Gross 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.
PubMed 1540116Simons, 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.
PubMed 526242Larsen 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.
PubMed 10245370Potter 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.
PubMed 40514778
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Internet-based Intervention for Dental Anxiety
- ClinicalTrials.gov ID
- NCT03680755
- Acronym / sponsor ID
- U01DE027328
- Conditions
- Dental Anxiety
- Keywords
- dental avoidance, dental phobia, pain sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial will evaluate the efficacy of a brief Internet-based cognitive-behavioral intervention for the treatment of impairing dental anxiety among those seeking dental care at the clinics of a university dental school. The primary objective of human subjects activities described in this protocol is to evaluate the efficacy of the Internet-based intervention for dental anxiety among patients presenting to the participating clinic(s). To achieve this overall objective, 2 primary objectives and 2 secondary objectives have been proposed:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This will be a single-center parallel groups study with randomization to one of three arms: (1) a treatment condition (Tr1) in which the dental anxiety intervention is administered by CBT personnel (n=150), (2) a treatment condition in which the dental anxiety intervention is administered by dental staff (Tr2) (n=150), or (3) an active control (AC) group (notification of the dental providers of the patient's score on a dental anxiety scale before their dental treatment appointment). In addition, control participants will be asked to view a video of nature scenes for a period of time equivalent to the dental anxiety intervention.
| Arm | Type | Receives |
|---|---|---|
| Tr1 group | Experimental | Behavioral: Internet-based intervention for dental anxietyParticipants 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. |
| Tr2 group | Experimental | Behavioral: Internet-based intervention for dental anxietyParticipants 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. |
| Active control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based intervention for dental anxietyParticipants 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. | Behavioural | Tr1 group, Tr2 group |
Primary outcome
Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995).
Time frame: The MDAS will be administered at the baseline assessment and at one- and three-month follow-ups.
The MDAS is a widely used 5-item measure assessing fear of dental procedures, including cleaning, drilling, and local anesthetic injections; for example, "If you were about to have your tooth drilled, how would you feel?" Items are rated on a 5-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). The total score ranges from 5 to 25; a score of 19 or above indicates high anxiety based on receiver operating characteristic analyses from previous studies.
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)
Time frame: The ADIS-5 will be administered at the baseline assessment and at one- and three-month follow-ups.
The ADIS-5 is a semi-structured interview designed to establish reliable diagnoses of the DSM-5 anxiety, mood, somatoform, and substance use disorders. To minimize participant burden, this study will utilize only the dental procedure-related section of the specific phobia module of the interview. This module includes ratings of fear and avoidance of dental procedures (0 = No fear/Never avoids to 8 = Very severe fear always avoids) as well as resultant interference (0 = None to 8 = Very severe; the latter being used to operationalize one of the inclusion criteria). For the dental phobia diagnosis, a dimensional clinical severity rating (CSR), ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. All interviews will be audio-recorded. The 0-8 rating of dental fear will serve as the primary measure derived from the ADIS-5.
9 secondary outcomes
Change in Avoidance Rating From the ADIS-5
Time frame: baseline assessment, and at one- and three-month follow-ups.
Pain Intensity Numeric Rating Scale (PI-NRS).
Time frame: These ratings will be administered as part of the post-appointment debriefing interview, as well as at the 1-month and 3-month follow-ups.
Pain Sensitivity Index (PSI; Gross, 1992a).
Time frame: It will be administered at baseline and the 1-month and 3-month follow-ups.
Distress Tolerance Scale (DTS; Simons & Gaher, 2005).
Time frame: The DTS will be administered at the baseline assessment and at one- and three-month follow-ups
Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979).
Time frame: It will be administered at the baseline assessment and at one- and three-month follow-ups.
Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979).
Time frame: The CSQ-8 will be administered post-intervention (within 48 hours after the participant's dental appointment), as well as at the one- and three-month follow-ups.
Change in Distress and Interference Rating From the ADIS-5
Time frame: baseline assessment, and at one- and three-month follow-ups.
Change in Percentage of Dentally Phobic Patients From the ADIS-5
Time frame: baseline assessment, and at one- and three-month follow-ups.
Change in Attendance at Dental Appointments
Time frame: 1 year post-dental anxiety intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7584581Humphris GM, Morrison T, Lindsay SJ. The Modified Dental Anxiety Scale: validation and United Kingdom norms. Community Dent Health. 1995 Sep;12(3):143-50.
- Background: PubMed 22876395Brahm 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.
- Background: PubMed 20463579Farrar 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.
- Background: PubMed 11690728Farrar 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.
- Background: PubMed 23746494Gordon 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.
- Background: PubMed 26202996Tellez 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.
- Background: PubMed 1540116Gross 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.
- BackgroundSimons, 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
- Background: PubMed 526242Marks 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.
- Background: PubMed 10245370Larsen 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.
- BackgroundPotter 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.
- Derived from this study: PubMed 40514778Tellez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisol Tellez Merchan, PhD principal investigator
Professor
Eugene M Dunne, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based intervention for dental anxiety in people with Dental Anxiety, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). (time frame: The MDAS will be administered at the baseline assessment and at one- and three-month follow-ups.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03680755, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.