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

Primary Purpose

Altered Passive Eruption of Teeth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ECL- mPZ
ECL-OF
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Altered Passive Eruption of Teeth focused on measuring Crown lengthening, Open-flap approach, Piezoelectric approach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Augusta University-Dental College of GeorgiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group: Crown lengthening using a traditional open-flap approach (OF).

Test group: Crown lengthening using a minimally invasive approach by piezoelectric (PZ).

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change on Probing depth (PD)
Change on Probing depth (PD)
Change on Bleeding on probing (BOP)
Change on Bleeding on probing (BOP)
Change clinical attachment level (CAL).
Change on clinical attachment level (CAL).

Full Information

First Posted
July 19, 2022
Last Updated
July 28, 2022
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT05478317
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
January 18, 2025 (Anticipated)
Study Completion Date
January 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Altered Passive Eruption of Teeth
Keywords
Crown lengthening, Open-flap approach, Piezoelectric approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group: Crown lengthening using a traditional open-flap approach (OF).
Arm Type
Active Comparator
Arm Description
Esthetic Crown lengthening done using a traditional open-flap approach (OF).
Arm Title
Test group: Crown lengthening using a minimally invasive approach by piezoelectric (PZ).
Arm Type
Experimental
Arm Description
Esthetic Crown lengthening done using a minimally invasive approach using piezoelectric (PZ).
Intervention Type
Procedure
Intervention Name(s)
ECL- mPZ
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ECL-OF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of supracrestal width (cementoenamel junction to alveolar crest CEJ-AC)
Description
Change of the supracrestal width will be measured using cone beam computed tomography (CBCT).
Time Frame
CBCT parameter will be evaluated before the surgery and at 12 month after the surgery.
Secondary Outcome Measure Information:
Title
Change on Probing depth (PD)
Description
Change on Probing depth (PD)
Time Frame
PD will be evaluated prior to surgery and 6 and 12 month after surgery
Title
Change on Bleeding on probing (BOP)
Description
Change on Bleeding on probing (BOP)
Time Frame
BOP will be evaluated prior to surgery and 6 and 12 month after surgery
Title
Change clinical attachment level (CAL).
Description
Change on clinical attachment level (CAL).
Time Frame
CAL will be evaluated prior to surgery and 6 and 12 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed El-Awady, BDS, MS, PHD
Phone
706-721-5755
Email
aelawady@augusta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jaspreet Farmaha, PHD
Phone
706-721-1270
Email
jfarmaha@augusta.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed El-Awady, BDS, MS, PHD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University-Dental College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed El-Awady, BDS, MS, PhD
Phone
706-721-5755
Email
aelawady@augusta.edu
First Name & Middle Initial & Last Name & Degree
Jaspreet Farmaha, PhD
Phone
7067211270
Email
jfarmaha@augusta.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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