Aesthetic Crown Lengthening: Laser Impact on Pain Perception and Perceptions on Self-esteem and Quality of Life

NCT06830434 | Completed

• 1 other identifier: 22735519.9.0000.5418
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Crown Lengthening; Pain Postoperative; Self Concept

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment through study completion, an average of 2 years

Study Arms (2)

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.

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.

Procedure: Crown lengthening surgery

Interventions

Crown lengthening surgery PROCEDURE

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.

Crown lenghtening surgery associated with Laser therapy; Crown lenghtening surgery without Laser therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

University of Campinas, UNICAMP

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Laser therapy will be performed in a blinded manner for the patients. The crown lengthening surgeon and the outcomes assessor will also be blinded-they will not know which side received the laser therapy. Only the laser operator will have access to this information. The quadrant receiving the therapy will be randomly selected using a computer program by the laser operator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: February 17, 2025
• Study Start: January 20, 2021
• Primary Completion: September 20, 2021
• Study Completion: March 20, 2022
• Last Updated: February 17, 2025

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)