Dental AnxietyNCT07018115
Anxiety and Hemodynamic Changes in Third Molar Extraction After Patient Education
A study testing Basic Preoperative Information, Detailed Verbal Preoperative Information and Visual Preoperative Information (2D Animation) in people with Dental Anxiety and Hemodynamic, run by Ummugulsum Coskun.
Trial summary
This randomized clinical trial investigates the effect of different preoperative patient information strategies on anxiety levels and hemodynamic responses during third molar extraction. Ninety-seven patients were assigned to control, verbal information, or visual (animation) information groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Hemodynamic, Molar, Third
- What is being tested?
- Basic Preoperative Information, Detailed Verbal Preoperative Information and Visual Preoperative Information (2D Animation)
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 10 Dec 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Requiring surgical removal of a impacted mandibular third molar
- Ability to read and complete the questionnaires
- Willingness to participate in the study
Who cannot join
- Age < 18 years
- History of systemic disease contraindicating surgery
- Poor oral hygiene
- Current pericoronitis or acute infection around the third molar
- Pregnancy
About this study
Official title: The Effect of Preoperative Patient Information Strategies on Anxiety and Hemodynamic Responses During Third Molar Extraction
This randomized clinical trial investigates the effect of different preoperative patient information strategies on anxiety levels and hemodynamic responses during third molar extraction. Ninety-seven patients were assigned to control, verbal information, or visual (animation) information groups. Anxiety was measured using the Modified Dental Anxiety Scale (MDAS) and State-Trait Anxiety Inventory (STAI), while heart rate, blood pressure, oxygen saturation, and pain were recorded. The study aims to assess whether educational interventions can reduce anxiety and improve patient comfort during oral surgery.
Read the detailed description
This prospective, randomized clinical trial was designed to evaluate the effect of different preoperative patient information strategies on anxiety levels, hemodynamic responses, and pain perception during the surgical extraction of impacted mandibular third molars. Third molar extraction is a common procedure in oral and maxillofacial surgery, often associated with elevated patient anxiety, which can negatively affect both psychological well-being and physiological parameters such as heart rate and blood pressure.
In this study, 97 patients requiring surgical removal of a single impacted mandibular third molar were recruited and randomly assigned into one of three groups:
- Control group - provided with a brief, basic explanation of the surgical procedure;
- Verbal information group - provided with a detailed, non-technical verbal explanation covering the anesthesia, surgical steps, and post-operative care;
- Visual information group - provided with the same verbal explanation plus an educational 2D animation illustrating the surgical process.
The anxiety levels of participants were measured using two validated scales: the Modified Dental Anxiety Scale (MDAS) and the State-Trait Anxiety Inventory (STAI), both before and after surgery. Physiological measurements, including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation (SaO₂), were recorded at five standardized time points: before surgery, after information delivery and before anesthesia, after anesthesia, during tooth extraction, and in the postoperative period. Pain levels were assessed during the procedure using a Visual Analog Scale (VAS).
All surgeries were conducted under local anesthesia by experienced oral surgeons, following a standardized surgical protocol to minimize operator-related variability. The study also considered demographic and clinical variables, such as patient age, sex, education level, and the depth of impaction of the third molar, as potential factors influencing anxiety and physiological responses.
The study was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Karadeniz Technical University, and received approval from the university's ethics committee (approval number 2015/30). The primary hypothesis was that providing patients with detailed verbal or visual information would reduce preoperative anxiety compared to basic explanations, and that visual tools might offer additional benefits by enhancing patient understanding and comfort.
The results demonstrated that while anxiety scores generally decreased postoperatively across all groups, the visual (animation) information group showed significantly better oxygen saturation levels during extraction and in the postoperative period, suggesting a positive physiological impact. However, no significant differences were found between groups regarding pain scores or overall surgical duration.
These findings highlight the importance of preoperative patient education and suggest that incorporating visual educational tools, such as animations, may improve physiological stability and patient experience during oral surgical procedures. Further research is warranted to refine these strategies and explore their long-term benefits in various dental and surgical contexts.
- Conditions
- Dental Anxiety, Hemodynamic, Molar, Third, Tooth Extraction, Tooth Impacted
- Being tested
- Basic Preoperative Information, Detailed Verbal Preoperative Information, Visual Preoperative Information (2D Animation), Articaine 4% with epinephrine 1:100,000, Surgical extraction of impacted mandibular third molar
- Keywords
- Dental Anxiety, Patient Education, Impacted Third Molar, Pain Management, Hemodynamic Changes
- Medical subject headings
- Tooth, Impacted, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Preoperative InformationOther
Also called Control Information; Minimal Explanation
Participants receive a brief, non-detailed explanation of the surgical procedure.
Detailed Verbal Preoperative InformationOther
Also called Verbal Explanation; Detailed Verbal Education; Verbal Counseling
Participants receive a detailed verbal explanation covering the surgical procedure, including anesthesia, incision, bone removal, tooth sectioning, and suturing.
Visual Preoperative Information (2D Animation)Other
Also called Animated Video; Visual Education; Animation-Based Information
Participants receive a 2D animated video illustrating the surgical procedure in addition to the detailed verbal explanation.
Articaine 4% with epinephrine 1:100,000Drug
A local anesthetic solution (Ultracain D-S; Aventis) administered in a dose of 2 ml for all patients. The anesthetic was injected to achieve regional nerve block anesthesia (inferior alveolar, lingual, and buccal nerves) prior to the surgical extraction of impacted mandibular third molars. The solution contains epinephrine as a vasoconstrictor to prolong anesthetic effect and minimize intraoperative bleeding.
Surgical extraction of impacted mandibular third molarProcedure or surgery
A standardized surgical protocol was followed for the removal of impacted mandibular third molars. All procedures were performed under local anesthesia using a mucoperiosteal flap approach. The surgery included a linear or triangular incision, elevation of the mucoperiosteal flap, ostectomy using rotary instruments as needed, and tooth sectioning in cases of difficult extraction. The socket was irrigated with sterile saline solution, and hemostasis was achieved. Wound closure was performed with 4.0 silk sutures. All surgeries were conducted by experienced oral and maxillofacial surgeons without sedation or premedication. The entire procedure was monitored for hemodynamic parameters including heart rate, blood pressure, and oxygen saturation.
Multiparameter patient monitorDevice
A hospital-grade multiparameter monitor was used to measure and record patients' vital signs at five defined surgical stages: before surgery, after information delivery, after local anesthesia, during tooth extraction, and postoperatively. The monitor continuously recorded heart rate (HR), systolic and diastolic blood pressure (SBP and DBP), and peripheral oxygen saturation (SpO₂). The collected data were used to evaluate physiological responses associated with anxiety and surgical stress.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Participants receive only a basic, brief explanation of the surgical procedure without additional detailed verbal or visual information. Receives: Other: Basic Preoperative Information; Drug: Articaine 4% with epinephrine 1:100,000; Procedure: Surgical extraction of impacted mandibular third molar; Device: Multiparameter patient monitor |
| Verbal Information Group | Experimental | Participants receive a comprehensive verbal explanation of the surgical procedure, covering all key steps such as anesthesia, incision, bone removal, tooth sectioning, and suturing, delivered in clear, non-technical language to optimize patient understanding. Receives: Other: Detailed Verbal Preoperative Information; Drug: Articaine 4% with epinephrine 1:100,000; Procedure: Surgical extraction of impacted mandibular third molar; Device: Multiparameter patient monitor |
| Visual Information Group | Experimental | Participants receive the same detailed verbal explanation as the verbal information group, supplemented with a 2D animated video illustrating the surgical procedure Receives: Other: Visual Preoperative Information (2D Animation); Drug: Articaine 4% with epinephrine 1:100,000; Procedure: Surgical extraction of impacted mandibular third molar; Device: Multiparameter patient monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Modified Dental Anxiety Scale (MDAS) Score After Third Molar Surgery
The Modified Dental Anxiety Scale (MDAS) is a validated questionnaire consisting of 5 items, each scored from 1 (not anxious) to 5 (extremely anxious), producing a total score range of 5 to 25. Higher scores indicate higher levels of dental anxiety. In this study, participants completed the MDAS before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in MDAS score from baseline to postoperative was calculated to assess the effect of patient education interventions on dental anxiety levels.
Measured: From baseline (before patient education) to within 1 hour after completion of third molar extraction
Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-Trait) Score After Third Molar Surgery
The Spielberger State-Trait Anxiety Inventory - Trait (STAI-T) subscale is a validated self-reported questionnaire with 20 items, each rated from 1 (almost never) to 4 (almost always), giving a total score between 20 and 80. Higher scores indicate higher levels of trait anxiety. In this study, participants completed the STAI-T before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in STAI-Trait score from baseline to postoperative was calculated to assess the effect of patient education on trait anxiety.
Measured: From baseline (before patient education) to within 1 hour after completion of third molar extraction
Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-State) Score After Third Molar Surgery
The Spielberger State-Trait Anxiety Inventory - State (STAI-S) subscale is a validated self-reported questionnaire with 20 items, each rated from 1 (not at all) to 4 (very much so), giving a total score between 20 and 80. Higher scores indicate higher levels of state anxiety. In this study, participants completed the STAI-S before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in STAI-State score from baseline to postoperative was calculated to assess the effect of patient education on state anxiety.
Measured: From baseline (before patient education) to within 1 hour after completion of third molar extraction
Secondary outcomes (6)
Change in Heart Rate (HR) During Third Molar Surgery
Heart rate was measured in beats per minute (bpm) at five predefined time points:
T1: 10 minutes before surgery (baseline), T2: 5 minutes after patient education and immediately before local anesthesia, T3: 5 minutes after local anesthesia administration, T4: At the moment of tooth removal (typically between minutes 12 and 20 of the procedure), T5: 10 minutes after completion of surgery and suturing. Changes in heart rate across these phases were analyzed to evaluate the physiological impact of surgical stress and preoperative patient information.
Measured: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Change in Systolic Blood Pressure (SBP) During Third Molar Surgery
Systolic blood pressure (SBP) was measured at five predefined time points:
T1: 10 minutes before surgery (baseline), T2: 5 minutes after patient education and immediately before local anesthesia, T3: 5 minutes after local anesthesia administration, T4: At the moment of tooth removal (typically between minutes 12 and 20 of the procedure), T5: 10 minutes after completion of surgery and suturing. Changes in SBP were analyzed to assess physiological responses to preoperative patient education and surgical stress.
Measured: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Change in Diastolic Blood Pressure (DBP) During Third Molar Surgery
Diastolic blood pressure (DBP) was measured in mmHg at five predefined time points:
T1: 10 minutes before surgery (baseline), T2: 5 minutes after patient education and immediately before local anesthesia, T3: 5 minutes after local anesthesia administration, T4: At the moment of tooth removal (typically between minutes 12 and 20 of the procedure), T5: 10 minutes after completion of surgery and suturing. These measurements were used to assess physiological stress responses during third molar surgery and the potential influence of preoperative patient education.
Measured: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Change in Peripheral Oxygen Saturation (SpO₂) During Third Molar Surgery
Peripheral oxygen saturation (SpO₂) was measured as a percentage (%) at five predefined time points:
T1: 10 minutes before surgery (baseline), T2: 5 minutes after patient education and immediately before local anesthesia, T3: 5 minutes after local anesthesia administration, T4: At the moment of tooth removal (typically between minutes 12 and 20 of the procedure), T5: 10 minutes after completion of surgery and suturing. These measurements were analyzed to identify potential changes in oxygen saturation associated with surgical stress and the impact of different patient education methods.
Measured: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Pain Intensity During Tooth Extraction Measured by Visual Analog Scale (VAS)
Pain was assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). Patients were asked to report their pain level immediately after the tooth was extracted, while still in the surgical setting. This measure reflects the intensity of pain experienced specifically at the moment of tooth removal and was used to evaluate its relationship with the type of preoperative patient education provided.
Measured: From the start of tooth elevation to immediately after tooth removal (approximately minutes 15 to 20 of the procedure)
Duration of Third Molar Extraction Procedure
The duration of the surgical procedure was recorded in minutes, starting with the first incision and ending with the placement of the final suture. This variable was used to evaluate whether the type of preoperative patient education influenced the total procedure time or surgical efficiency.
Measured: From the first surgical incision to the final suture placement (approximately 10 to 30 minutes total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jun 2015
- Primary completion10 Feb 2016
- Study completion10 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized, parallel assignment clinical trial allocates participants into three independent groups to compare the effects of different preoperative patient information strategies (basic explanation, detailed verbal explanation, visual animation) on anxiety levels and physiological responses during third molar extraction. Each group receives only its assigned type of information, and outcomes are measured and compared separately across the groups.
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ummugulsum Coskun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ummugulsum Coskun, Altinbas University
- Investigators
- Ummugulsum Coskun, DDS, PhD, Principal investigator, Altinbas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018115
- Sponsor's protocol ID
- 2015/30
- Status last verified
- Jun 2025
- First submitted
- 25 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be made available to qualified researchers upon reasonable request after publication of the study results.
Publications
Coskun U, Altintas NY, Cezairli B, Atasoy KT. Impact of preoperative patient information on anxiety and physiological responses in mandibular third molar surgery: A randomized controlled trial. Med Oral Patol Oral Cir Bucal. 2026 Mar 7;31(4):e537-45. doi: 10.4317/medoral.27904. Online ahead of print.
PubMed 41793732
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Patient Information Strategies on Anxiety and Hemodynamic Responses During Third Molar Extraction
- ClinicalTrials.gov ID
- NCT07018115
- Acronym / sponsor ID
- 2015/30
- Conditions
- Dental Anxiety, Hemodynamic, Molar, Third, Tooth Extraction, Tooth Impacted
- Keywords
- Dental Anxiety, Patient Education, Impacted Third Molar, Pain Management, Hemodynamic Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Ummugulsum CoskunUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 10 Feb 2016 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 12 Jun 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.
This randomized clinical trial investigates the effect of different preoperative patient information strategies on anxiety levels and hemodynamic responses during third molar extraction. Ninety-seven patients were assigned to control, verbal information, or visual (animation) information groups. Anxiety was measured using the Modified Dental Anxiety Scale (MDAS) and State-Trait Anxiety Inventory (STAI), while heart rate, blood pressure, oxygen saturation, and pain were recorded. The study aims to assess whether educational interventions can reduce anxiety and improve patient comfort during oral surgery.
Detailed description
This prospective, randomized clinical trial was designed to evaluate the effect of different preoperative patient information strategies on anxiety levels, hemodynamic responses, and pain perception during the surgical extraction of impacted mandibular third molars. Third molar extraction is a common procedure in oral and maxillofacial surgery, often associated with elevated patient anxiety, which can negatively affect both psychological well-being and physiological parameters such as heart rate and blood pressure.
In this study, 97 patients requiring surgical removal of a single impacted mandibular third molar were recruited and randomly assigned into one of three groups:
- Control group - provided with a brief, basic explanation of the surgical procedure;
- Verbal information group - provided with a detailed, non-technical verbal explanation covering the anesthesia, surgical steps, and post-operative care;
- Visual information group - provided with the same verbal explanation plus an educational 2D animation illustrating the surgical process.
The anxiety levels of participants were measured using two validated scales: the Modified Dental Anxiety Scale (MDAS) and the State-Trait Anxiety Inventory (STAI), both before and after surgery. Physiological measurements, including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation (SaO₂), were recorded at five standardized time points: before surgery, after information delivery and before anesthesia, after anesthesia, during tooth extraction, and in the postoperative period. Pain levels were assessed during the procedure using a Visual Analog Scale (VAS).
All surgeries were conducted under local anesthesia by experienced oral surgeons, following a standardized surgical protocol to minimize operator-related variability. The study also considered demographic and clinical variables, such as patient age, sex, education level, and the depth of impaction of the third molar, as potential factors influencing anxiety and physiological responses.
The study was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Karadeniz Technical University, and received approval from the university's ethics committee (approval number 2015/30). The primary hypothesis was that providing patients with detailed verbal or visual information would reduce preoperative anxiety compared to basic explanations, and that visual tools might offer additional benefits by enhancing patient understanding and comfort.
The results demonstrated that while anxiety scores generally decreased postoperatively across all groups, the visual (animation) information group showed significantly better oxygen saturation levels during extraction and in the postoperative period, suggesting a positive physiological impact. However, no significant differences were found between groups regarding pain scores or overall surgical duration.
These findings highlight the importance of preoperative patient education and suggest that incorporating visual educational tools, such as animations, may improve physiological stability and patient experience during oral surgical procedures. Further research is warranted to refine these strategies and explore their long-term benefits in various dental and surgical contexts.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This randomized, parallel assignment clinical trial allocates participants into three independent groups to compare the effects of different preoperative patient information strategies (basic explanation, detailed verbal explanation, visual animation) on anxiety levels and physiological responses during third molar extraction. Each group receives only its assigned type of information, and outcomes are measured and compared separately across the groups.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Basic Preoperative Information, Drug: Articaine 4% with epinephrine 1:100,000, Procedure: Surgical extraction of impacted mandibular third molar, Device: Multiparameter patient monitorParticipants receive only a basic, brief explanation of the surgical procedure without additional detailed verbal or visual information. |
| Verbal Information Group | Experimental | Other: Detailed Verbal Preoperative Information, Drug: Articaine 4% with epinephrine 1:100,000, Procedure: Surgical extraction of impacted mandibular third molar, Device: Multiparameter patient monitorParticipants receive a comprehensive verbal explanation of the surgical procedure, covering all key steps such as anesthesia, incision, bone removal, tooth sectioning, and suturing, delivered in clear, non-technical language to optimize patient understanding. |
| Visual Information Group | Experimental | Other: Visual Preoperative Information (2D Animation), Drug: Articaine 4% with epinephrine 1:100,000, Procedure: Surgical extraction of impacted mandibular third molar, Device: Multiparameter patient monitorParticipants receive the same detailed verbal explanation as the verbal information group, supplemented with a 2D animated video illustrating the surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Requiring surgical removal of a impacted mandibular third molar
- Ability to read and complete the questionnaires
- Willingness to participate in the study
Key exclusion criteria (5 listed)
- Age < 18 years
- History of systemic disease contraindicating surgery
- Poor oral hygiene
- Current pericoronitis or acute infection around the third molar
- Pregnancy
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 |
|---|---|---|
| Basic Preoperative InformationAlso: Control Information; Minimal ExplanationParticipants receive a brief, non-detailed explanation of the surgical procedure. | Other | Control Group |
| Detailed Verbal Preoperative InformationAlso: Verbal Explanation; Detailed Verbal Education; Verbal CounselingParticipants receive a detailed verbal explanation covering the surgical procedure, including anesthesia, incision, bone removal, tooth sectioning, and suturing. | Other | Verbal Information Group |
| Visual Preoperative Information (2D Animation)Also: Animated Video; Visual Education; Animation-Based InformationParticipants receive a 2D animated video illustrating the surgical procedure in addition to the detailed verbal explanation. | Other | Visual Information Group |
| Articaine 4% with epinephrine 1:100,000A local anesthetic solution (Ultracain D-S; Aventis) administered in a dose of 2 ml for all patients. The anesthetic was injected to achieve regional nerve block anesthesia (inferior alveolar, lingual, and buccal nerves) prior to the surgical extraction of impacted mandibular third molars. The solution contains epinephrine as a vasoconstrictor to prolong anesthetic effect and minimize intraoperative bleeding. | Drug | Control Group, Verbal Information Group, Visual Information Group |
| Surgical extraction of impacted mandibular third molarA standardized surgical protocol was followed for the removal of impacted mandibular third molars. All procedures were performed under local anesthesia using a mucoperiosteal flap approach. The surgery included a linear or triangular incision, elevation of the mucoperiosteal flap, ostectomy using rotary instruments as needed, and tooth sectioning in cases of difficult extraction. The socket was irrigated with sterile saline solution, and hemostasis was achieved. Wound closure was performed with 4.0 silk sutures. All surgeries were conducted by experienced oral and maxillofacial surgeons without sedation or premedication. The entire procedure was monitored for hemodynamic parameters including heart rate, blood pressure, and oxygen saturation. | Procedure or surgery | Control Group, Verbal Information Group, Visual Information Group |
| Multiparameter patient monitorA hospital-grade multiparameter monitor was used to measure and record patients' vital signs at five defined surgical stages: before surgery, after information delivery, after local anesthesia, during tooth extraction, and postoperatively. The monitor continuously recorded heart rate (HR), systolic and diastolic blood pressure (SBP and DBP), and peripheral oxygen saturation (SpO₂). The collected data were used to evaluate physiological responses associated with anxiety and surgical stress. | Device | Control Group, Verbal Information Group, Visual Information Group |
Primary outcome
Change from Baseline in Modified Dental Anxiety Scale (MDAS) Score After Third Molar Surgery
Time frame: From baseline (before patient education) to within 1 hour after completion of third molar extraction
The Modified Dental Anxiety Scale (MDAS) is a validated questionnaire consisting of 5 items, each scored from 1 (not anxious) to 5 (extremely anxious), producing a total score range of 5 to 25. Higher scores indicate higher levels of dental anxiety. In this study, participants completed the MDAS before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in MDAS score from baseline to postoperative was calculated to assess the effect of patient education interventions on dental anxiety levels.
Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-Trait) Score After Third Molar Surgery
Time frame: From baseline (before patient education) to within 1 hour after completion of third molar extraction
The Spielberger State-Trait Anxiety Inventory - Trait (STAI-T) subscale is a validated self-reported questionnaire with 20 items, each rated from 1 (almost never) to 4 (almost always), giving a total score between 20 and 80. Higher scores indicate higher levels of trait anxiety. In this study, participants completed the STAI-T before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in STAI-Trait score from baseline to postoperative was calculated to assess the effect of patient education on trait anxiety.
Change from Baseline in Spielberger State-Trait Anxiety Inventory (STAI-State) Score After Third Molar Surgery
Time frame: From baseline (before patient education) to within 1 hour after completion of third molar extraction
The Spielberger State-Trait Anxiety Inventory - State (STAI-S) subscale is a validated self-reported questionnaire with 20 items, each rated from 1 (not at all) to 4 (very much so), giving a total score between 20 and 80. Higher scores indicate higher levels of state anxiety. In this study, participants completed the STAI-S before receiving any information (preoperative baseline) and again immediately after third molar extraction (postoperative). The change in STAI-State score from baseline to postoperative was calculated to assess the effect of patient education on state anxiety.
6 secondary outcomes
Change in Heart Rate (HR) During Third Molar Surgery
Time frame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Change in Systolic Blood Pressure (SBP) During Third Molar Surgery
Time frame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Change in Diastolic Blood Pressure (DBP) During Third Molar Surgery
Time frame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Change in Peripheral Oxygen Saturation (SpO₂) During Third Molar Surgery
Time frame: From 10 minutes before local anesthesia to 10 minutes after completion of surgery (total duration approximately 30 minutes)
Pain Intensity During Tooth Extraction Measured by Visual Analog Scale (VAS)
Time frame: From the start of tooth elevation to immediately after tooth removal (approximately minutes 15 to 20 of the procedure)
Duration of Third Molar Extraction Procedure
Time frame: From the first surgical incision to the final suture placement (approximately 10 to 30 minutes total)
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 12 Jun 2025.
- Derived from this study: PubMed 41793732Coskun U, Altintas NY, Cezairli B, Atasoy KT. Impact of preoperative patient information on anxiety and physiological responses in mandibular third molar surgery: A randomized controlled trial. Med Oral Patol Oral Cir Bucal. 2026 Mar 7;31(4):e537-45. doi: 10.4317/medoral.27904. Online ahead of print.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available to qualified researchers upon reasonable request after publication of the study results.
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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.
Ummugulsum Coskun, DDS, PhD principal investigator
Altinbas University
Questions about this trial
What is this clinical trial studying?
A study testing Basic Preoperative Information, Detailed Verbal Preoperative Information and Visual Preoperative Information (2D Animation) in people with Dental Anxiety and Hemodynamic, run by Ummugulsum Coskun.
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 5 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline in Modified Dental Anxiety Scale (MDAS) Score After Third Molar Surgery (time frame: From baseline (before patient education) to within 1 hour after completion of third molar extraction). The study lists 3 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 NCT07018115, which also lists 1 linked publication.
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 12 Jun 2025.