Esthetic Crown Lengthening With Closed Piezoelectric in Comparison to Open Flap Approach

Altered Passive Eruption of Teeth Clinical Trial

Official title:

Esthetic Crown Lengthening With Closed Piezoelectric in Comparison to Open Flap Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478317
• Other study ID #: 1807704
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: January 18, 2025

Study information

• Verified date: July 2022
• Source: Augusta University
• Contact: Ahmed El-Awady, BDS, MS, PHD
• Phone: 706-721-5755
• Email: aelawady[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this randomized clinical trial, the investigators are comparing two different approaches for Esthetic crown lengthening- a minimally invasive approach using piezoelectric (PZ) and a traditional open flap approach (OF).

Description:

The altered passive eruption is diagnosed when there is an excessive gingival display with short clinical crowns. Esthetic crown lengthening (ECL) is the most common surgical treatment of altered passive eruption. Traditional ECL involves osseous resection with gingivectomy or apical displaced gingiva. The amount of soft and hard tissue removal in this technique aims to provide a healthy and esthetically acceptable crown height. However, gingival tissue coronal rebound is one of the most noted post-operative complications of traditionally used techniques. On the other hand, surgical techniques that include flap reflection may cause more coronal displacement of the gingival margin. Hence, it is crucial to assess different surgical techniques to determine the most effective technique that gives the required outcomes with maximum patient satisfaction. Piezoelectric bone surgery delivers high precision in resection, good tactile sensibility, and permits a selective cut of mineralized tissue while sparing soft tissue. Further, the minimally invasive technique (mECL) was suggested to reduce pain, post-op discomfort, and procedure duration, and to accelerate the healing process. The mECL technique conveys a potential alternative approach as a sutureless, atraumatic, and less invasive technique that has been shown to increase patient satisfaction and comfort. In addition, using piezoelectric for osseous resection in this closed approach increases the favorable surgical outcomes. However, the osseous resection in mECL may be incomplete and results in a coronal rebound on the gingival contour. In addition, osseous resection in this approach is very technique sensitive to avoid root damage and uneven bone resection. A few studies and even a fewer clinical trials evaluated the clinical outcome of mECL using piezoelectric for osseous resection (PZ). Hence, in this randomized clinical trial, gingival margin and bone crest stability will be evaluated after a minimally invasive approach using piezoelectric (PZ) and a traditional open flap approach (OF).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 18, 2025
• Est. primary completion date: January 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a gummy smile due to APE (Type 1B) in two or more maxillary anterior teeth
• Patients with normal muscular efficiency of the upper lip
• Patients with no vertical skeletal defects

Exclusion Criteria:

• Patients with systemic condition that prevent periodontal surgery
• Patients who smoke
• Patients with previous periodontal surgery in the same area
• Pregnant women

Related Conditions & MeSH terms

• Altered Passive Eruption of Teeth
• Exanthema

Intervention

Procedure:
• ECL- mPZ
Flapless Technique using Piezoelectric (PZ): Gingivectomy and intra-sulcular incision will be carried out to remove strip of outlined marginal gingiva. However, no flap will be reflected the osseous recontouring will be carried using special piezoelectric tip below gingival margin. The required distance between the bone crest and the gingival margin will be checked by inserting a periodontal probe into the incision below gingival margin.
• ECL-OF
Open Flap Technique (OF): Gingivectomy and intra-sulcular incision will be carried out to remove strip of outlined marginal gingiva. Full mucoperiosteal flap will be elevated to preform ostectomy and/or osteoplasty until the desired distance achieved between the bone crest and the gingival margin. After achieving the new supracrestal distance, the flap will be sutured.

Locations

Country	Name	City	State
United States	Augusta University-Dental College of Georgia	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of supracrestal width (cementoenamel junction to alveolar crest CEJ-AC)	Change of the supracrestal width will be measured using cone beam computed tomography (CBCT).	CBCT parameter will be evaluated before the surgery and at 12 month after the surgery.
Secondary	Change on Probing depth (PD)	Change on Probing depth (PD)	PD will be evaluated prior to surgery and 6 and 12 month after surgery
Secondary	Change on Bleeding on probing (BOP)	Change on Bleeding on probing (BOP)	BOP will be evaluated prior to surgery and 6 and 12 month after surgery
Secondary	Change clinical attachment level (CAL).	Change on clinical attachment level (CAL).	CAL will be evaluated prior to surgery and 6 and 12 month after surgery