"Impact of the Third Molars in Oral Health-related Quality of Life"

Health-related Quality of Life Clinical Trial

Official title:

"Impact of the Third Molars in Oral Health-related Quality of Life"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05044481
• Other study ID #: ORD 1809 / 12-08-2019
• Status: Completed
• Start date: February 5, 2019
• Est. completion date: June 14, 2020

Study information

• Verified date: September 2021
• Source: Hospital Carlos Van Buren
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the impact of the third molars in oral health-related quality of life, before and after surgical removal using a validated and frequently used in international investigations instrument (OHIP-14).

Description:

This is a prospective study that evaluates the oral health-related quality of life through the application of the self-administered OHIP-14 before and after the surgical removal of third molars. The inclusion criteria were adults' patients older than 18 years, referred for oral surgery. Patients with chronic diseases and acute pericoronitis were excluded. The assessment was performed at three times: pre-surgical planning 1 day before surgery (T0), 10 days (T1) and 2 - 3 months after surgery (T2)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 14, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patients over 18 years old

Exclusion Criteria:

• Patients with chronic diseases and acute pericoronitis

Related Conditions & MeSH terms

• Health-related Quality of Life
• Third Molar

Intervention

Procedure:
• third molar surgical removal
ambulatory surgical intervention of the maxilla and / or mandible for third molar removal

Locations

Country	Name	City	State
Chile	Valentina Duarte	Valparaíso

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Carlos Van Buren	Universidad de La Frontera

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)	Short form Oral Health Impact Profile (OHIP-14) was applied at 3 times: baseline, one week before surgery (T1), 10 days after surgery (T2) and 2 - 3 months after surgery (T3).; A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM).; The Short Form Oral Health Impact Profile (OHIP-14) is an instrument for assessment oral health-related quality of life.; 14 ítems values: min = 0 / max = 56 higher scores mean a worse outcome	baseline to 10 days and 2 - 3 months after surgery