Crown LengtheningNCT06830434
Aesthetic Crown Lengthening: Laser Impact on Pain Perception and Perceptions on Self-esteem and Quality of Life
A study testing Crown lengthening surgery in people with Crown Lengthening and Pain Postoperative, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crown Lengthening, Pain Postoperative, Self Concept
- What is being tested?
- Crown lengthening surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jan 2021to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Crown Lengthening, Pain Postoperative, Self Concept
- Being tested
- Crown lengthening surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crown lengthening surgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Crown lenghtening surgery associated with Laser therapy | Experimental | 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. Receives: Procedure: Crown lengthening surgery |
| Crown lenghtening surgery without Laser therapy | Placebo comparator | After crown lenghtening surgery in aesthetic area, all the 20 patients, will not receive laser treatment on an oral side. Receives: Procedure: Crown lengthening surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' levels of self-esteem and quality of life
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.
Measured: From enrollment through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start20 Jan 2021
- Primary completion20 Sep 2021
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crown LengtheningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Twenty patients will be selected based on their interest in undergoing aesthetic crown lengthening surgery in the anterior maxillary region and their indication for the procedure. Two questionnaires will be administered: the OHIP-14/Brazil and the Rosenberg Self-Esteem Scale - UNIFESP/EPM. In one study arm, laser therapy will be performed in a blinded manner immediately after the surgical procedure.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Casarin, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830434
- Sponsor's protocol ID
- 22735519.9.0000.5418
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Crown Lengthening: Laser Impact on Pain Perception and Surgery Impact on Self-esteem and Quality of Life Perceptions
- ClinicalTrials.gov ID
- NCT06830434
- Acronym / sponsor ID
- 22735519.9.0000.5418
- Conditions
- Crown Lengthening, Pain Postoperative, Self Concept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Twenty patients will be selected based on their interest in undergoing aesthetic crown lengthening surgery in the anterior maxillary region and their indication for the procedure. Two questionnaires will be administered: the OHIP-14/Brazil and the Rosenberg Self-Esteem Scale - UNIFESP/EPM. In one study arm, laser therapy will be performed in a blinded manner immediately after the surgical procedure.
| Arm | Type | Receives |
|---|---|---|
| Crown lenghtening surgery associated with Laser therapy | Experimental | Procedure: Crown lengthening surgeryAfter 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. |
| Crown lenghtening surgery without Laser therapy | Placebo comparator | Procedure: Crown lengthening surgeryAfter crown lenghtening surgery in aesthetic area, all the 20 patients, will not receive laser treatment on an oral side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crown lengthening surgeryFollowing 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. | Procedure or surgery | Crown lenghtening surgery associated with Laser therapy, Crown lenghtening surgery without Laser therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Crown Lengthening
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Comparison of Er:YAG Assisted Laser Crown Lengthening Against Surgical Crown Lengthening
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Laser-Assisted Minimally Invasive Esthetic Crown Lengthening Using Flapless vs. Tunneled Flap Approach
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crown lengthening surgery in people with Crown Lengthening and Pain Postoperative, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' levels of self-esteem and quality of life (time frame: From enrollment through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.