Anxiety and Hemodynamic Changes in Third Molar Extraction After Patient Education

NCT07018115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-06-12

No results posted yet for this study

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

Interventions

OTHER

Basic Preoperative Information

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

OTHER

Detailed Verbal Preoperative Information

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

OTHER

Visual Preoperative Information (2D Animation)

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

DRUG

Articaine 4% with epinephrine 1:100,000

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.

PROCEDURE

Surgical extraction of impacted mandibular third molar

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.

DEVICE

Multiparameter patient monitor

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.

Sponsors & Collaborators

  • Ummugulsum Coskun

    lead OTHER

Principal Investigators

  • Ummugulsum Coskun, DDS, PhD · Altinbas University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2016-02-10
Completion
2016-12-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018115 on ClinicalTrials.gov