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

Anxiety and Fear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06388265
• Other study ID #: 18/2018, Acta 26-6-2018
• Status: Completed
• Phase: N/A
• Start date: January 9, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: May 2024
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety and Fear

Intervention

Other:
• Trifold information
Additional detailed and written information about the procedure will be given to the participants

Locations

Country	Name	City	State
Spain	Hospital Odontològic Universitat de Barcelona	L'Hospitalet De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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