Dental AnxietyNCT07124273
Effect of Dental Anxiety on Mandibular Anesthesia Success
A study testing Standardized Mandibular Anesthesia Protocol in people with Dental Anxiety and Symptomatic Irreversible Pulpitis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effect of dental anxiety on the success of mandibular anesthesia in patients with symptomatic irreversible pulpitis in mandibular molar teeth. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Anxiety, Symptomatic Irreversible Pulpitis
- What is being tested?
- Standardized Mandibular Anesthesia Protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years
- Systemically healthy individuals who agree to participate in the study
- Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis requiring root canal treatment
- Teeth with closed apex and no periapical lesions visible radiographically
- Periodontally healthy teeth according to Glickman's criteria, with probing depth ≤ 3 mm
- Teeth with mobility less than 0.5 mm
- Patients experiencing moderate (55-113 mm) or severe pain (114-170 mm) according to the Heft-Parker Visual Analog Scale (HP-VAS)
Who cannot join
- Patients with any systemic disease
- Teeth with open apex or radiographic evidence of periapical pathology
- Teeth showing internal or external root resorption
- Teeth that do not meet Glickman's periodontal health criteria or have probing depth > 3 mm
- Teeth with mobility greater than 0.5 mm
- Patients experiencing no pain (0 mm) or mild pain (1-54 mm) on the HP-VAS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University Faculty of Dentistry
Kütahya
About this study
Official title: The Effect of Dental Anxiety on the Success of Mandibular Anesthesia in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: A Prospective Clinical Study
The goal of this clinical trial is to evaluate the effect of dental anxiety on the success of mandibular anesthesia in patients with symptomatic irreversible pulpitis in mandibular molar teeth.
The main questions it aims to answer are:
Read more
Does dental anxiety influence the success rate of inferior alveolar nerve block (IANB)? Is there a correlation between salivary cortisol levels and anesthesia outcomes in anxious patients?
Researchers will compare two groups of patients based on their Modified Dental Anxiety Scale (MDAS) scores:
Low/No anxiety group (MDAS < 10) Moderate to high anxiety group (MDAS ≥ 11, including those with dental phobia)
Participants will:
Rate their pre-treatment pain using the Heft-Parker Visual Analog Scale (HP-VAS) Provide salivary samples for cortisol measurement before and after anesthesia Undergo standardized mandibular anesthesia protocols (IANB and buccal-lingual infiltration) Report pain during treatment using the HP-VAS Undergo monitoring of SpO₂ and pulse via pulse oximetry To control for cortisol fluctuations and circadian rhythm, all procedures and saliva collections will occur between 09:00-12:00. Participants will be asked to avoid food for at least 2 hours prior, and refrain from caffeine, alcohol, smoking, or heavy exercise for at least 24 hours before treatment.
- Conditions
- Dental Anxiety, Symptomatic Irreversible Pulpitis
- Being tested
- Standardized Mandibular Anesthesia Protocol
- Keywords
- Dental Anxiety, Local Anesthesia Failure, Salivary Cortisol, Symptomatic Irreversible Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Mandibular Anesthesia ProtocolProcedure or surgery
Participants receive an inferior alveolar nerve block (IANB) using 1.8 ml 4% articaine with 1:100,000 epinephrine (Ultracaine DS Forte) via a 27-gauge dental needle, followed by buccal and lingual infiltration anesthesia after 5 minutes. Topical 10% lidocaine spray is applied prior to injection. All procedures are performed by the same clinician between 09:00-12:00. Salivary cortisol, pulse oximetry, and pain assessments are conducted before and after the anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Low Anxiety Group | Experimental | Participants with Modified Dental Anxiety Scale (MDAS) scores less than 10. Receives: Procedure: Standardized Mandibular Anesthesia Protocol |
| Moderate-High Anxiety Group | Experimental | Participants with MDAS scores of 11 or higher, including those with dental phobia (MDAS > 19). Receives: Procedure: Standardized Mandibular Anesthesia Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Mandibular Anesthesia
The success of inferior alveolar nerve block (IANB) will be determined based on the patient's pain response during endodontic treatment, measured using the Heft-Parker Visual Analog Scale (HP-VAS). Anesthesia will be considered successful if pain during treatment is rated as "none" or "mild" on HP-VAS.
Measured: Within 30 minutes after anesthesia administration, during the endodontic procedure
Secondary outcomes (2)
Correlation Between Dental Anxiety Level and Anesthesia Success
Relationship between Modified Dental Anxiety Scale (MDAS; score range 5-25, higher scores indicate greater anxiety) and anesthesia success rates during a single endodontic treatment session.
Measured: At the end of the single treatment session (within 30 minutes after anesthesia administration)
Salivary Cortisol Level Change
Difference in salivary cortisol levels measured 15 minutes before and 15 minutes after anesthesia to assess stress response related to dental anxiety.
Measured: Pre-anesthesia and 15 minutes post-anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start15 Dec 2023
- Primary completion15 Jun 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124273
- Sponsor's protocol ID
- KutahyaHSU-3
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dental Anxiety on the Success of Mandibular Anesthesia in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07124273
- Acronym / sponsor ID
- KutahyaHSU-3
- Conditions
- Dental Anxiety, Symptomatic Irreversible Pulpitis
- Keywords
- Dental Anxiety, Local Anesthesia Failure, Salivary Cortisol, Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the effect of dental anxiety on the success of mandibular anesthesia in patients with symptomatic irreversible pulpitis in mandibular molar teeth.
The main questions it aims to answer are:
Does dental anxiety influence the success rate of inferior alveolar nerve block (IANB)? Is there a correlation between salivary cortisol levels and anesthesia outcomes in anxious patients?
Researchers will compare two groups of patients based on their Modified Dental Anxiety Scale (MDAS) scores:
Low/No anxiety group (MDAS < 10) Moderate to high anxiety group (MDAS ≥ 11, including those with dental phobia)
Participants will:
Rate their pre-treatment pain using the Heft-Parker Visual Analog Scale (HP-VAS) Provide salivary samples for cortisol measurement before and after anesthesia Undergo standardized mandibular anesthesia protocols (IANB and buccal-lingual infiltration) Report pain during treatment using the HP-VAS Undergo monitoring of SpO₂ and pulse via pulse oximetry To control for cortisol fluctuations and circadian rhythm, all procedures and saliva collections will occur between 09:00-12:00. Participants will be asked to avoid food for at least 2 hours prior, and refrain from caffeine, alcohol, smoking, or heavy exercise for at least 24 hours before treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Anxiety Group | Experimental | Procedure: Standardized Mandibular Anesthesia ProtocolParticipants with Modified Dental Anxiety Scale (MDAS) scores less than 10. |
| Moderate-High Anxiety Group | Experimental | Procedure: Standardized Mandibular Anesthesia ProtocolParticipants with MDAS scores of 11 or higher, including those with dental phobia (MDAS > 19). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged between 18 and 65 years
- Systemically healthy individuals who agree to participate in the study
- Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis requiring root canal treatment
- Teeth with closed apex and no periapical lesions visible radiographically
- Periodontally healthy teeth according to Glickman's criteria, with probing depth ≤ 3 mm
Key exclusion criteria (6 listed)
- Patients with any systemic disease
- Teeth with open apex or radiographic evidence of periapical pathology
- Teeth showing internal or external root resorption
- Teeth that do not meet Glickman's periodontal health criteria or have probing depth > 3 mm
- Teeth with mobility greater than 0.5 mm
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 |
|---|---|---|
| Standardized Mandibular Anesthesia ProtocolParticipants receive an inferior alveolar nerve block (IANB) using 1.8 ml 4% articaine with 1:100,000 epinephrine (Ultracaine DS Forte) via a 27-gauge dental needle, followed by buccal and lingual infiltration anesthesia after 5 minutes. Topical 10% lidocaine spray is applied prior to injection. All procedures are performed by the same clinician between 09:00-12:00. Salivary cortisol, pulse oximetry, and pain assessments are conducted before and after the anesthesia. | Procedure or surgery | Low Anxiety Group, Moderate-High Anxiety Group |
Primary outcome
Success Rate of Mandibular Anesthesia
Time frame: Within 30 minutes after anesthesia administration, during the endodontic procedure
The success of inferior alveolar nerve block (IANB) will be determined based on the patient's pain response during endodontic treatment, measured using the Heft-Parker Visual Analog Scale (HP-VAS). Anesthesia will be considered successful if pain during treatment is rated as "none" or "mild" on HP-VAS.
2 secondary outcomes
Correlation Between Dental Anxiety Level and Anesthesia Success
Time frame: At the end of the single treatment session (within 30 minutes after anesthesia administration)
Salivary Cortisol Level Change
Time frame: Pre-anesthesia and 15 minutes post-anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Mandibular Anesthesia Protocol in people with Dental Anxiety and Symptomatic Irreversible Pulpitis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 7 inclusion and 6 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 15 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success Rate of Mandibular Anesthesia (time frame: Within 30 minutes after anesthesia administration, during the endodontic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025.