NCT07887438

Brief Summary

The goal of this clinical trial is to compare and evaluate the effectiveness of conventional surgery and Piezo-surgery for the treatment of gummy smile. The main question it aims to answer: "Which of these treatment modalities (conventional open flap crown lengthening with rotary handpiece and Flapless crown lengthening with Piezoelectric ultrasound has the best clinical results with least morbidity and least relapse in treatment of gummy smile?" Researchers will compare: The primary outcome was the decrease in excessive gingival display by measuring the length of clinical crown and width of keratinized gingiva before and after treatment modalities. The The secondary outcome was to measure the durability and possibility of relapse over 6 months after treatment with high patient satisfaction

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2024

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 21, 2026

Last Update Submit

October 14, 2026

Conditions

Keywords

Altered passive eruption

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was clinical crown lengthening.

    The primary outcome was crown lengthening confirmed by measuring the increase of the relative gingival margin (RGM) in mm from the incisal edge of the vacum stent to the gingival margin before and after the treatment modalities.

    Baseline, 1 week, 3 months and 6 months post-operatively.

Secondary Outcomes (8)

  • Secondary outcome was comparing the morbidity of the open flap group to the minimally invasive flapless group

    24 hours and one week after the surgery.

  • Bleeding on probing

    Baseline, 1 week, 3 months and 6 months post-operatively.

  • Gingival Index

    Baseline, 1 week, 3 months and 6 months post-operatively.

  • Plaque Index

    Baseline, 1 week, 3 months and 6 months post-operatively.

  • Clinical attachment level (CAL)

    Baseline, 1 week, 3 months and 6 months post-operatively.

  • +3 more secondary outcomes

Study Arms (2)

Flapless Piezo-surgery

EXPERIMENTAL

15 Patients selected had a gummy smile with type 1B APE Following administration of local anesthesia (4% lidocaine with 1:100,000 epinephrine) at the surgical site, gingivectomy was performed through an internal beveled incision followed by a sulcular incision, allowing removal of the gingival tissue. After the sulcular incision, a minimal access approach was adopted: a tunneling procedure was carried out using a small mucoperiosteal elevator, limited to the facial surface and deliberately avoiding the interproximal areas in order to preserve the interdental papillae and maintain soft tissue integrity. Osteotomy was performed using a Woodpecker Piezo- Surgical tip UL48, which allowed precise and conservative bone removal to achieve the desired distance between the gingival margin and the alveolar bone crest without elevating a flap. The target biological width was ensured by maintaining approximately 2 mm between the bone crest and the cementoenamel junction. No sutures were placed.

Procedure: piezo-electric surgery

Conventional open flap crown lengthening

ACTIVE COMPARATOR

15 patients with type 1B APE gummy smile were treated using the conventional open flap approach: After administration of local anesthesia (4% lidocaine with 1:100,000 epinephrine) at the surgical site, gingivectomy was performed using a #15 surgical blade to remove the excess gingival tissue and to define the contour of the gingival margin, an internal beveled incision was then made at the buccal aspect of the involved teeth, followed by a sulcular incision to detach the remaining gingival collar. A full-thickness mucoperiosteal flap was then carefully reflected to provide accessibility to the alveolar crest. Bone recontouring was performed with surgical burs mounted on a rotary handpiece under copious irrigation until a distance of approximately 2 mm between the between the alveolar crest and the cementoenamel junction (CEJ) was achieved to re-establish the biologic width. Finally, internal vertical mattress sutures were placed at the interdental papillae using 4-0 black silk suture.

Procedure: conventional open flap crown lengthening

Interventions

Flapless piezo-surgery technique used for aesthetic crown lengthening in patients with gummy smile

Flapless Piezo-surgery

conventional open flap technique used for aesthetic crown lengthening in patients with gummy smile

Conventional open flap crown lengthening

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient's age ranges from 20 to 40 years old.
  • Both genders were included.
  • Medically free individuals. (according to Cornell medical index)
  • Patients with gingival smile due to APE 1B in at least 3 maxillary teeth (central incisors, lateral incisors, canines, or premolars).
  • Bone thickness type: (thin to moderate).
  • No clinical attachment loss

You may not qualify if:

  • Alcoholics and smokers.
  • Patients with systemic illnesses or disorders that compromise wound healing.
  • Patients on medications causing gingival enlargement.
  • Pregnant women or lactating mothers.
  • Patients with orthodontic appliances at the time of the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

periodontology clinic, faculty of dentistry Suez canal university

Ismailia, Ismailia Governorate, 41511, Egypt

Location

MeSH Terms

Interventions

Piezosurgery

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Shaimaa Mohammed Morsy, PHD in periodontology

    Suez Canal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-blinded technique
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2026

First Posted

October 21, 2026

Study Start

February 11, 2023

Primary Completion

November 19, 2023

Study Completion

April 21, 2024

Last Updated

October 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations