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

NCT06388265 | Completed DMC

• 1 other identifier: 18/2018, Acta 26-6-2018
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety and Fear

Outcome Measures

Primary Outcomes (2)

• Changes in STAI-S

  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: 1. At the initial consultation (baseline) 2. Immediately before the procedure and administration of the local anaesthetic solution 3. Immediately after the procedure is completed 4. 1 week after the procedure (exodontia)

  Through study completion, an average of 5 weeks

• Changes in MDAS

  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: 1. At the initial consultation (baseline) 2. Immediately before the procedure and administration of the local anaesthetic solution

  up to 3 weeks

Secondary Outcomes (4)

• Changes in blood pressure

  Through study completion, an average of 5 weeks

• Changes in Heart rate

  Through study completion, an average of 5 weeks

• Changes in Oxygen saturation

  Through study completion, an average of 5 weeks

• Patient Satisfaction of procedure

  1 week after the procedure

Study Arms (2)

Verbal and Written detailed information

EXPERIMENTAL

The experimental group will receive verbal information about the procedure (exodontia of third molars) and additionally a trifold with detailed information about the surgical procedure.

Other: Trifold information

Control

NO INTERVENTION

The control group will only receive verbal information about the surgical procedure.

Interventions

Trifold information OTHER

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

Verbal and Written detailed information

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Hospital Odontològic Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• José López-López, PhD

  University of Barcelona

  STUDY DIRECTOR

• Mayra Schemel Suarez, DDS

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 29, 2024
• Study Start: January 9, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)