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Clinical Trials/NCT05478317
NCT05478317RecruitingNot Applicable

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

Augusta University2 sites in 1 country36 target enrollmentStarted: May 18, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
36
Locations
2
Primary Endpoint
Change of supracrestal width (cementoenamel junction to alveolar crest CEJ-AC)

Study Overview

Brief 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).

Detailed 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change of supracrestal width (cementoenamel junction to alveolar crest CEJ-AC)

Time Frame: CBCT parameter will be evaluated before the surgery and at 12 month after the surgery.

Change of the supracrestal width will be measured using cone beam computed tomography (CBCT).

Secondary Outcomes

  • Change on Probing depth (PD)(PD will be evaluated prior to surgery and 6 and 12 month after surgery)
  • Change on Bleeding on probing (BOP)(BOP will be evaluated prior to surgery and 6 and 12 month after surgery)
  • Change clinical attachment level (CAL).(CAL will be evaluated prior to surgery and 6 and 12 month after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed El-Awady

Assistant Professor

Augusta University

Study Sites (2)

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