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Completed

NCT Number: NCT05044481

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

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).

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Key information

Conditions

Health-Related Quality of Life Third Molar

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Valentina Duarte

Valparaíso, Chile

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients over 18 years old

Exclusion criteria

  • Patients with chronic diseases and acute pericoronitis

Treatment and study plan

third molar surgical removal

Procedure

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

Primary outcomes

  1. changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)

    Time frame: baseline to 10 days and 2 - 3 months after surgery

    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

Sponsors and collaborators

Lead sponsor

Hospital Carlos Van Buren

Other

Collaborators

  • Universidad de La Frontera

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2021
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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