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.

Study Overview

• Status: Completed
• Conditions: Anxiety and Fear
• Intervention / Treatment: Other: Trifold information

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Hospital Odontològic Universitat de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verbal and Written detailed information; 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; Additional detailed and written information about the procedure will be given to the participants
No Intervention: Control; The control group will only receive verbal information about the surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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)	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: At the initial consultation (baseline); Immediately before the procedure and administration of the local anaesthetic solution	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure	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; 1 week after the procedure (exodontia)	Through study completion, an average of 5 weeks
Changes in Heart rate	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; 1 week after the procedure (exodontia)	Through study completion, an average of 5 weeks
Changes in Oxygen saturation	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; 1 week after the procedure (exodontia)	Through study completion, an average of 5 weeks
Patient Satisfaction of 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	1 week after the procedure

Collaborators and Investigators

• Sponsor: University of Barcelona
• Investigators: Study Director: José López-López, PhD, University of Barcelona; Principal Investigator: Mayra Schemel Suarez, DDS, University of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18/2018, Acta 26-6-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No