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OpenTrials
Completed

NCT Number: NCT06388265

Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars

Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona.

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Key information

Conditions

Anxiety and Fear Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Odontològic Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals 18 years old or older, from both genders that wished to voluntarily participate in the study and that required the extraction of third molars.

Exclusion criteria

  • Systemic diseases (ASA III or IV) that contraindicate the performance of the surgical procedure
  • Pregnant women
  • Individuals that did not understand and/or could not respond the given questionnaire.
  • Patients that required the extraction of a different tooth than a third molar or that required the extraction of more than two third molars in the same surgical time.
  • Patients who had undergone extraction of a third molar in the twelve months prior to the current visit.
  • Patients taking antidepressant medication or anxiolytic medication

Treatment and study plan

Trifold information

Other

Additional detailed and written information about the procedure will be given to the participants

Primary outcomes

  1. Changes in STAI-S

    Time frame: Through study completion, an average of 5 weeks

    The Anxiety State scale (S-Anxiety) is an inventory that has been validated and assesses the current state of anxiety of the participant measured through an auto evaluation, asking how the evaluated individual feels "in this moment", using items that measure subjective feelings of apprehension, tension, nervousness, worry and activation/excitement of the autonomic nervous system.

    The total scores can go from 20 to 80 points A cut point value of 39 to 40 points has been suggested to detect clinically significant symptoms in the Anxiety State scale.

    STAI-S will be assessed in 4 stages:

    • At the initial consultation (baseline)
    • Immediately before the procedure and administration of the local anaesthetic solution
    • Immediately after the procedure is completed
    • 1 week after the procedure (exodontia)

  2. Changes in MDAS

    Time frame: up to 3 weeks

    The modified dental anxiety scale (MDAS) is an auto evaluation questionnaire about dental anxiety that contains 5 items, each one with 5 possible answers that reflects in order an increase of anxiety (no anxiety to extremely anxious).

    The total score can go from 5 points to a maximum of 25 points. The lower limit to define an individual with extreme anxiety is 19 points and to define the presence of anxiety the score must be higher than 10 points.

    MDAS will be assessed in 2 stages:

    • At the initial consultation (baseline)
    • Immediately before the procedure and administration of the local anaesthetic solution

Secondary outcomes

  1. Changes in blood pressure

    Time frame: Through study completion, an average of 5 weeks

    Changes in Blood pressure (Systolic and dyastolic) measured in mmHg

    Blood pressure will be assessed in 5 stages:

    • At the initial consultation (baseline)
    • Immediately before the procedure and administration of the local anaesthetic solution
    • Immediately after administration of the local anaesthetic solution
    • Immediately after the procedure is completed

  2. Changes in Heart rate

    Time frame: Through study completion, an average of 5 weeks

    Changes in heart rate measured in beats per minute

    Heart rate will be assessed in 5 stages:

    • At the initial consultation (baseline)
    • Immediately before the procedure and administration of the local anaesthetic solution
    • Immediately after administration of the local anaesthetic solution
    • Immediately after the procedure is completed

  3. Changes in Oxygen saturation

    Time frame: Through study completion, an average of 5 weeks

    Changes in oxygen saturation measured in percentage (%)

    Oxygen saturation will be assessed in 5 stages:

    • At the initial consultation (baseline)
    • Immediately before the procedure and administration of the local anaesthetic solution
    • Immediately after administration of the local anaesthetic solution
    • Immediately after the procedure is completed

  4. Patient Satisfaction of procedure

    Time frame: 1 week after the procedure

    A questionnaire will be provided to the participants that consists of 6 questions, 2 questions to know the degree of discomfort at the last visit (suture removal control post exodontia) with 4 possible answers: none, little, moderate, a lot; and 4 questions to determine the degree of satisfaction with all the dental treatment carried out with affirmative or negative answers

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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