NCT05044481

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

September 12, 2021

Last Update Submit

September 12, 2021

Conditions

Health-related Quality of LifeThird Molar

Keywords

Health-related quality of lifethird molar

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

third molar surgical removalPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years old submmited to third molars surgical removal

You may qualify if:

  • Adults patients over 18 years old

You may not qualify if:

  • Patients with chronic diseases and acute pericoronitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valentina Duarte

Valparaíso, Chile

Location

Study Officials

  • Valentina Duarte

    Hospital Carlos Van Buren

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2021

First Posted

September 14, 2021

Study Start

February 5, 2019

Primary Completion

March 3, 2020

Study Completion

June 14, 2020

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)