Recruiting

Closed Piezoelectric vs. Open Flap

Sponsor:

Augusta University

Code:

NCT05478317

Conditions

Altered Passive Eruption of Teeth

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ECL- mPZ

ECL-OF

Study Details

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).

Conditions

Altered Passive Eruption of Teeth

Study ID

NCT05478317

Start date

May 18, 2022

Status verified date

Jul, 2022

Completion date

Jan 18, 2025

Anticipated

Primary completion date

Jan 18, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

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).

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Ahmed El-Awady, BDS, MS, PHD

706-721-5755aelawady@augusta.edu

Jaspreet Farmaha, PHD

706-721-1270jfarmaha@augusta.edu

Locations

Augusta University-Dental College of Georgia

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Ahmed El-Awady, BDS, MS, PhD

706-721-5755aelawady@augusta.edu

Jaspreet Farmaha, PhD

7067211270jfarmaha@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Aug 1, 2022

Last verified

Jul, 2022

Keywords

  • Crown lengthening
  • Open-flap approach
  • Piezoelectric approach

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2022-08-01.