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

NCT05478317 | Unknown

• 1 other identifier: 1807704
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Crown lengthening; Open-flap approach; Piezoelectric approach

Outcome Measures

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).

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

Secondary Outcomes (3)

• 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

Study Arms (2)

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

ACTIVE COMPARATOR

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

Procedure: ECL-OF

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

EXPERIMENTAL

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

Procedure: ECL- mPZ

Interventions

ECL- mPZ PROCEDURE

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.

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

ECL-OF PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University-Dental College of Georgia

Augusta, Georgia, 30912, United States

RECRUITING

Study Officials

• Ahmed El-Awady, BDS, MS, PHD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed El-Awady, BDS, MS, PHD

CONTACT

706-721-5755; aelawady@augusta.edu

Jaspreet Farmaha, PHD

CONTACT

706-721-1270; jfarmaha@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 28, 2022
• Study Start: May 18, 2022
• Primary Completion: January 18, 2025
• Study Completion: January 18, 2025
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)