- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06830434
Aesthetic Crown Lengthening: Laser Impact on Pain Perception and Perceptions on Self-esteem and Quality of Life
February 11, 2025 updated by: Renato Casarin, University of Campinas, Brazil
Aesthetic Crown Lengthening: Laser Impact on Pain Perception and Surgery Impact on Self-esteem and Quality of Life Perceptions
Gummy smile is a condition that promotes a disharmonious smile, altering confidence and decreasing self-esteem of many patients.
Luckily, this problem in most cases is easily solved by aesthetic crown lengthening surgery.
However, this is a surgery that is still considered by many patients to be painful and uncomfortable.
Thereby, this study seeks both to evaluate possible changes in patients' self-esteem and self-confidence after the aesthetic crown lengthening surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Periodontally healthy patients who expressed interest in undergoing ACL will be selected.
Before surgery, two questionnaires will be administered: the OHIP-14/Brazil and the Rosenberg Self-Esteem Scale-UNIFESP/EPM.
These tools are designed to assess patients' perceptions of self-esteem and quality of life and will be re-administered 30 days and one year after surgery.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Piracicaba, São Paulo, Brazil, 13414-903
- University of Campinas, UNICAMP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Periodontal health diagnosis (full mouth bleeding on probing - BP <10%, clinical attachment level - CAL ≤ 3mm),
- Distance from the gingival margin to the cementum-enamel junction ≥ 3mm associated with a gingival smile and / or short clinical crowns when compared to anatomical crowns, due to the altered passive eruption or gingival overgrowth).
- Good general health
Exclusion Criteria:
- Presence of systemic changes (diabetes, heart disease, hepatitis, etc.)
- Use of medications (such as antibiotics, continuous anti-inflammatory drugs, phenytoin, cyclosporine) that may influence the response to the surgical treatment
- Diagnosis of gingivitis and/or periodontitis
- Smoking habit
- Pregnancy or lactation period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Crown lenghtening surgery associated with Laser therapy
After crown lenghtening surgery in aesthetic area, the laser will be applied on the "Right" or "Left" oral side (chosen randomly), in all the 20 patients, in a "Split-mouth" model.
|
Following clinical and radiographic examinations and thorough case planning, surgical procedures were performed under local anesthesia by a single operator.
After anesthesia, the distance from the gingival margin to the cementoenamel junction will be measured, and these values will be transferred to the gingival tissue to guide the procedure.
Excess gingival tissue will be excised, and, when necessary, an osteotomy will be performed to re-establish the supracrestal attachment tissues.
|
|
Placebo Comparator: Crown lenghtening surgery without Laser therapy
After crown lenghtening surgery in aesthetic area, all the 20 patients, will not receive laser treatment on an oral side.
|
Following clinical and radiographic examinations and thorough case planning, surgical procedures were performed under local anesthesia by a single operator.
After anesthesia, the distance from the gingival margin to the cementoenamel junction will be measured, and these values will be transferred to the gingival tissue to guide the procedure.
Excess gingival tissue will be excised, and, when necessary, an osteotomy will be performed to re-establish the supracrestal attachment tissues.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' levels of self-esteem and quality of life
Time Frame: From enrollment through study completion, an average of 2 years
|
The perceptions of self-esteem and quality will be measured through the OHIP-14/Brazil and the Rosenberg/UNIFESP-EPM Self-Esteem Scale questionnaires.The Rosenberg questionnaire addresses an individual's overall sense of self-worth and self-acceptance, evaluating both positive and negative self-perception domains to provide a holistic view of their self-esteem.
It consists of 10 statements rated on a 4-point Likert scale, with responses ranging from 'Strongly Agree' to 'Strongly Disagree.'
Scores range from 0 to 30, where higher scores indicate greater self-esteem, while lower scores suggest diminished self-worth or a negative self-view.
The OHIP-14 (Oral Health Impact Profile-14) questionnaire evaluates the impact of oral health on an individual's quality of life.
It measures functional and psychological well-being across seven domains to assess how oral conditions affect daily life and overall well-being.
|
From enrollment through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2021
Primary Completion (Actual)
September 20, 2021
Study Completion (Actual)
March 20, 2022
Study Registration Dates
First Submitted
October 5, 2020
First Submitted That Met QC Criteria
February 11, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 11, 2025
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22735519.9.0000.5418
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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