Clinical trial NCT05478317: Esthetic Crown Lengthening With Closed Piezoelectric in Comparison to Open Flap Approach
Official title: Esthetic Crown Lengthening With Closed Piezoelectric in Comparison to Open Flap Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Altered Passive Eruption of Teeth
Keywords: Crown lengthening
Open-flap approach
Piezoelectric approach
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects' matching inclusion criteria will be randomly assigned to control (OF) or tested (PZ) groups. After eligibility has been ascertained and consent has been obtained, subjects planned for ECL will be enrolled in the study and assigned to the group in 1:1 ratio using computer-generated block randomization scheme.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of supracrestal width (cementoenamel junction to alveolar crest CEJ-AC)
timeFrame: CBCT parameter will be evaluated before the surgery and at 12 month after the surgery.
Secondary outcomes:
measure: Change on Probing depth (PD)
timeFrame: PD will be evaluated prior to surgery and 6 and 12 month after surgery
measure: Change on Bleeding on probing (BOP)
timeFrame: BOP will be evaluated prior to surgery and 6 and 12 month after surgery
measure: Change clinical attachment level (CAL).
timeFrame: CAL will be evaluated prior to surgery and 6 and 12 month after surgery
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University-Dental College of Georgia
state: Georgia
Study officials:
affiliation: Augusta University
name: Ahmed El-Awady, BDS, MS, PHD
role: PRINCIPAL_INVESTIGATOR
References: