Anxiety and Hemodynamic Changes in Third Molar Extraction After Patient Education

NCT07018115 | Completed

• 1 other identifier: 2015/30
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Dental Anxiety; Hemodynamic; Molar, Third; Tooth Extraction; Tooth Impacted

Keywords

Dental Anxiety; Patient Education; Impacted Third Molar; Pain Management; Hemodynamic Changes

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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

  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

  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

  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)

  From the start of tooth elevation to immediately after tooth removal (approximately minutes 15 to 20 of the procedure)

Study Arms (3)

Control Group

OTHER

Participants receive only a basic, brief explanation of the surgical procedure without additional detailed verbal or visual information.

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.

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

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

Interventions

Basic Preoperative Information OTHER

Participants receive a brief, non-detailed explanation of the surgical procedure.

Also known as: Control Information; Minimal Explanation

Control Group

Detailed Verbal Preoperative Information OTHER

Participants receive a detailed verbal explanation covering the surgical procedure, including anesthesia, incision, bone removal, tooth sectioning, and suturing.

Also known as: Verbal Explanation; Detailed Verbal Education; Verbal Counseling

Verbal Information Group

Visual Preoperative Information (2D Animation) OTHER

Participants receive a 2D animated video illustrating the surgical procedure in addition to the detailed verbal explanation.

Also known as: Animated Video; Visual Education; Animation-Based Information

Visual Information Group

Articaine 4% with epinephrine 1:100,000 DRUG

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.

Control Group; Verbal Information Group; Visual Information Group

Surgical extraction of impacted mandibular third molar PROCEDURE

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.

Control Group; Verbal Information Group; Visual Information Group

Multiparameter patient monitor DEVICE

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.

Control Group; Verbal Information Group; Visual Information Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• History of systemic disease contraindicating surgery
• Poor oral hygiene
• Current pericoronitis or acute infection around the third molar
• Pregnancy

Sponsors & Collaborators

• Ummugulsum Coskun: lead

MeSH Terms

Conditions

Tooth, Impacted; Agnosia

Interventions

Carticaine; Epinephrine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ummugulsum Coskun, DDS, PhD

  Altinbas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the interventions, which involved providing different types of preoperative patient education (basic explanation, detailed verbal explanation, visual animation), masking was not feasible, and both participants and investigators were aware of group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Oral and Maxillofacial Surgery, DDS, PhD

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 12, 2025
• Study Start: June 1, 2015
• Primary Completion: February 10, 2016
• Study Completion: December 10, 2016
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The individual participant data (IPD) and supporting information will be available upon publication of the study results and will remain available for 5 years thereafter.
• Access Criteria: Qualified researchers can request IPD, protocol, and analysis plan by contacting the corresponding author. Data will be shared under a data use agreement after review.