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The influence of cheek fat removal on face measurements, satisfaction with facial esthetics and quality of life: a clinical trial

The influence of partial removal of the buccal extension of the fat pad from the cheek on the variation of measures and facial parameters, satisfaction with facial aesthetics and quality of life: a single-arm clinical trial - The Influence of Partial Removal of the Buccal Extension of the Fat Pad from the cheek on the variation of measures and facial parameters, satisfaction with facial aesthetics and quality of life: a single-arm clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6dzcg8g
Enrollment
Unknown
Registered
2021-09-28
Start date
2021-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cheek

Interventions

In prior consultation with the surgical procedure, data related to sex, age, general health status, BMI, blood count, platelet count, international normalized ratio (INR), lipidogram, fasting blood gl
Z54.0

Sponsors

Centro Universitário Christus - UNICHRISTUS
Lead Sponsor
Centro Universitário Christus - UNICHRISTUS
Collaborator

Eligibility

Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Healthy individuals (American Society of Anesthesiologists - ASA I) of both sexes; aged between 18-45 years; with the need to partially remove the buccal extension of the Bichat ball bilaterally

Exclusion criteria

Exclusion criteria: Smoking volunteers; pregnant or lactating women; signs of any preoperative inflammatory or infectious condition; systemic diseases

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study will be changes in clinical parameters related to facial volume. This outcome will be assessed through the linear measurement of points on the face of the volunteers. This outcome will be assessed through the linear measurement of points on the face of the volunteers, lines will be used between certain facial points, on the operated side. Such distances will be measured in millimeters from the mandibular angle (AM) to: tragus (distance AM-Tr); external corner of the eye (distance AM-CEO); wing of the nose (distance AM-AN); labial commissure (distance AM-CL); soft pogonion (distance AM-PM). The differences obtained between the preoperative values and those obtained in the postoperative evaluations (7 days, 1 month, 3 months and 6 months) will be compared.

Secondary

MeasureTime frame
Evaluation of postoperative pain and trismus and facial volume. Patients will be evaluated daily for the perception of postoperative pain using a 10-point analog visual scale and consumption of rescue medication in the first seven days after the surgical procedure. Pain assessment will be performed considering the right and left sides. The evaluation of the mouth opening limitation (trismus) will be measured by means of the maximum mouth opening capacity in periods determined below. For this, a digital caliper interposed between the incisal edges of the upper and lower central incisors will be used. The differences obtained between the preoperative values and those obtained in the postoperative evaluations (7 days, 1 month, 3 months and 6 months) will be compared.;To assess quality of life, each patient will receive a questionnaire called the Oral Health Impact Profile (OHIP-14), which basically focuses on negative effects of oral health on quality of life. The OHIP-14 questionnaire consists of 14 questions distributed in seven Domains. Two questions will be applied to each of the seven domains (functional limitation, physical pain, psychological discomfort, physical handicap, psychological handicap, social handicap and social handicap). The questions refer to how many times individuals have experienced difficulty in chewing, difficulty in pronouncing words, discomfort in eating, concern about dental problems, less flavor in food, interrupting meals, feeling upset or ashamed, avoiding going out or facing problems and being unable to work because of dental problems. Measured on a 5-point Likert scale, OHIP-14 calculates the prevalence, extent and severity of quality of life scores according to Shugars et al. (2006): the percentage of volunteers who report one or more items “reasonably” or “very often” will represent a measure of prevalence. An item reported "quite often" or "very often" will be considered clinically important and detrimental to quality of life. In a

Countries

Brazil

Contacts

Public ContactEdson Cetira Filho

Universidade Federal do Ceará

edson.cetira@hotmail.com5585997219653

Outcome results

None listed

Source: REBEC (via WHO ICTRP)