Closed Piezoelectric vs. Open Flap for Esthetic Crown Lengthening

Overseen By Jaspreet Farmaha, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Disqualifiers: Systemic conditions, Smoking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for esthetic crown lengthening, a dental procedure that makes teeth appear longer. One method uses a new, less invasive tool called piezoelectric (PZ), while the other employs the traditional open-flap approach (OF). Researchers aim to determine which method is more effective for individuals with a gummy smile due to altered passive eruption, where gums cover too much of the teeth. Suitable candidates have a gummy smile affecting at least two front upper teeth, normal lip movement, and no major jaw issues. As an unphased trial, this study provides a unique opportunity to explore innovative dental techniques that could enhance smiles.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these crown lengthening techniques are safe?

Research shows that the minimally invasive piezoelectric (PZ) method for cosmetic crown lengthening is well-tolerated. Studies have found that this method helps maintain gum stability over time. No major reports of serious side effects have emerged. The traditional open-flap (OF) method, a common procedure, is generally considered safe but involves more gum exposure. Both treatments appear safe, but the PZ method might offer a gentler experience with less gum disturbance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the piezoelectric approach for esthetic crown lengthening because it offers a minimally invasive alternative to the traditional open-flap method. Unlike the open-flap technique, which involves cutting and lifting the gums, the piezoelectric method uses ultrasonic vibrations to reshape the bone without extensive gum surgery. This approach could result in quicker recovery times, less discomfort, and more precise results, making it a promising option for patients seeking improved aesthetics with less hassle.

What evidence suggests that these crown lengthening techniques could be effective?

This trial will compare two methods for esthetic crown lengthening: a minimally invasive approach using piezoelectric (PZ) and a traditional open-flap approach (OF). Research has shown that the gentle piezoelectric technique for cosmetic crown lengthening can be beneficial. Studies have found that this method causes significantly less pain and swelling after the procedure compared to traditional methods. Evidence also indicates that the gums remain more stable three months after the procedure, reducing the likelihood of movement and maintaining a better appearance. Overall, the piezoelectric method may lead to a more comfortable recovery and lasting results. ^{1 2 3 6 7}

Who Is on the Research Team?

Ahmed El-Awady, BDS, MS, PHD

Principal Investigator

Augusta University

Are You a Good Fit for This Trial?

This trial is for individuals with a gummy smile caused by excess gum tissue over their upper front teeth and normal muscle function of the upper lip. They should not have had previous gum surgery in that area, be non-smokers, free from systemic conditions preventing gum surgery, and not pregnant.

Inclusion Criteria

I have a gummy smile because of my upper front teeth's appearance.

My upper lip moves normally.

You do not have any issues with the alignment of your spine.

Exclusion Criteria

I have had gum surgery in the same area before.

People who smoke.

I have a health condition that prevents me from having gum surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo esthetic crown lengthening using either a minimally invasive piezoelectric approach or a traditional open flap approach

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in supracrestal width, probing depth, bleeding on probing, and clinical attachment level

12 months

3 visits (in-person) at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• ECL-mPZ
• ECL-OF

Trial Overview The study is comparing two techniques for improving the appearance of 'gummy smiles': a minimally invasive method using piezoelectric tools (ECL-mPZ) versus the traditional method where gums are pushed back through surgery (ECL-OF).

How Is the Trial Designed?

Group I: Test group: Crown lengthening using a minimally invasive approach by piezoelectric (PZ). Experimental Treatment 1 Intervention

Esthetic Crown lengthening done using a minimally invasive approach using piezoelectric (PZ).

Group II: Control group: Crown lengthening using a traditional open-flap approach (OF). Active Control 1 Intervention

Esthetic Crown lengthening done using a traditional open-flap approach (OF).

ECL-mPZ is already approved in European Union, United States for the following indications:

Approved in European Union as Esthetic Crown Lengthening for:

• Restorative needs
• Esthetic concerns

Approved in United States as Esthetic Crown Lengthening for:

• Restorative needs
• Esthetic concerns

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Published Research Related to This Trial

Atraumatic surgical extrusion using a periotome was successfully performed on four isolated teeth in the esthetic zone, providing an alternative to traditional crown lengthening techniques.

This method avoids functional or esthetic deformities, making it particularly suitable for restorative and non-restorative cases in the anterior esthetic zone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atraumatic surgical extrusion using periotome in esthetic zone: A case series. Mohan, KP., Ravindra, RN., Roopa, D., et al.[2021]

The guided dual technique for esthetic crown lengthening (ECL) was found to be as effective as the conventional technique, with both methods resulting in significant increases in clinical crown length immediately after the procedure and stable results after 12 months, based on a study of 24 participants.

Participants reported high esthetic satisfaction with both techniques, indicating that the guided dual technique does not compromise aesthetic outcomes while potentially enhancing surgical predictability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital planning and guided dual technique in esthetic crown lengthening: a randomized controlled clinical trial. Carrera, TMI., Freire, AEN., de Oliveira, GJPL., et al.[2023]

Crown lengthening is essential for maintaining healthy gums and achieving good aesthetics during restorative dental procedures, as it helps preserve the biological width of the periodontium.

Piezosurgery, which uses ultrasonic technology for precise cutting, is an effective and safe method for performing crown lengthening, making it suitable for complex dental cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Present Day Approach to Crown Lengthening - Piezosurgery. Lavu, V., Arumugam, C., Venkatesan, N., et al.[2023]

Crown lengthening is a common periodontal surgery aimed at correcting issues like subgingival caries and short clinical abutments, but its use for esthetic purposes in the anterior areas lacks a standardized evidence-based approach.

This paper outlines critical aspects of the esthetic crown-lengthening procedure, including ideal flap design, bone removal guidelines, flap margin positioning, and healing phase management, which are essential for achieving optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crown lengthening and restorative procedures in the esthetic zone. Marzadori, M., Stefanini, M., Sangiorgi, M., et al.[2019]

The article reviews the evolution of esthetic crown lengthening (ECL) surgery techniques over 30 years, focusing on improvements in incision methods, bone removal (ostectomy), and tissue placement.

It also addresses the issue of tissue rebound, which can affect the outcomes of ECL surgery, highlighting the importance of technique modifications for better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esthetic Crown Lengthening Surgery - A 30-Year Retrospective and Lessons Learned. Robbins, JW.[2022]

The modified esthetic crown lengthening surgery (ECLS) technique significantly improved periodontal esthetic parameters, as shown by the increase in the mean crown lengthening esthetic score (CLES) from 15.23 to 20.30 after 6 months in a study of 15 patients.

The study introduced a new method for categorizing esthetic outcomes, which may help in evaluating the effectiveness of ECLS, particularly in terms of gingival zenith and papillae, while noting that gingival recession did not change significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified technique for esthetic crown lengthening in the natural dentition: case series. Lobo, M., Monteiro, MF., Rodrigues, RQF., et al.[2022]

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/113a138deeffd68e/nct05478317-esthetic-crown-lengthening-piezoelectric-flap-approach

Esthetic Crown Lengthening With Closed Piezoelectric in ... In this randomized clinical trial, the investigators are comparing two different approaches for Esthetic crown lengthening- a minimally invasive approach using ...

2. researchgate.net researchgate.net/publication/335238739_Aesthetic_Crown_Lengthening_with_Flapless_Piezoelectric_Surgery_in_Comparison_with_Traditional_Open_Flap_Approach

Aesthetic Crown Lengthening with Flapless Piezoelectric ... This study aimed to compare the clinical results of a minimally invasive flapless approach and an open-flap approach in aesthetic crown lengthening.

3. sciencedirect.com sciencedirect.com/science/article/pii/S277255962300007X

Open-flap versus minimally invasive esthetic crown ... A minimally invasive closed flap approach using piezoelectric instruments, in the appropriate cases, seem to have better gingival margin stability at 3 months.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38747087/

Evaluation of minimally invasive esthetic crown ... Conclusions: Within the current study's limitations, piezo-surgical ECL with FL-approach presented significantly lower postoperative pain, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jerd.13247?af=R

Evaluation of minimally invasive esthetic crown ... Within the current study's limitations, piezo-surgical ECL with FL-approach presented significantly lower postoperative pain, swelling, and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05478317/esthetic-crown-lengthening-with-closed-piezoelectric-in-comparison-to-open-flap-approach

Esthetic Crown Lengthening With Closed Piezoelectric in ... In this randomized clinical trial, the investigators are comparing two different approaches for Esthetic crown lengthening- a minimally invasive approach using ...

7. augusta.elsevierpure.com augusta.elsevierpure.com/en/publications/open-flap-versus-minimally-invasive-esthetic-crown-lengthening-sy

Open-flap versus minimally invasive esthetic crown ... Conclusions: A minimally invasive closed flap approach using piezoelectric instruments, in the appropriate cases, seem to have better gingival margin stability ...