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Status unknownNCT05478317Updated Aug 1, 2022

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

An interventional study of ECL- mPZ and ECL-OF in Altered Passive Eruption of Teeth, sponsored by Augusta University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-01.

Sponsored by Augusta University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Altered Passive Eruption of Teeth

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Keywords

  • Crown lengthening
  • Open-flap approach
  • Piezoelectric approach
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Patients with systemic condition that prevent periodontal surgery
  • Patients who smoke
  • Patients with previous periodontal surgery in the same area
  • Pregnant women
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

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

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

    Procedure: ECL-OF

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

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

    Procedure: ECL- mPZ

Interventions

  • ProcedureECL- 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.

  • ProcedureECL-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.

05

What researchers measure

Primary outcomes

  1. 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).

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

Secondary outcomes

  1. Change on Probing depth (PD)

    Change on Probing depth (PD)

    Time frame: PD will be evaluated prior to surgery and 6 and 12 month after surgery

  2. Change on Bleeding on probing (BOP)

    Change on Bleeding on probing (BOP)

    Time frame: BOP will be evaluated prior to surgery and 6 and 12 month after surgery

  3. Change clinical attachment level (CAL).

    Change on clinical attachment level (CAL).

    Time frame: CAL will be evaluated prior to surgery and 6 and 12 month after surgery

06

Study locations

1 of 1 sites recruiting
  • Augusta University-Dental College of Georgia
    Augusta, Georgia 30912, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05478317
Lead sponsor
Augusta University
Responsible party
Ahmed El-Awady (Assistant Professor, Augusta University) — Principal investigator
First posted
Jul 28, 2022
Start date
May 18, 2022
Primary completion
Jan 18, 2025 (estimated)
Completion
Jan 18, 2025 (estimated)
Last update
Aug 1, 2022

Study contacts

Ahmed El-Awady, BDS, MS, PHD
Contact
aelawady@augusta.edu
706-721-5755
Jaspreet Farmaha, PHD
Contact
jfarmaha@augusta.edu
706-721-1270
Ahmed El-Awady, BDS, MS, PHD
principal investigator · Augusta University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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