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CompletedNCT07887438Piezo-GumUpdated Oct 21, 2026

Comparing Two Techniques to Treat Gummy Smile Patients: Flapless Piezo-surgery Versus Conventional Open Flap Surgery.

An interventional study of piezo-electric surgery and conventional open flap crown lengthening in Altered Passive Eruption, sponsored by Suez Canal University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Feb 2023, registered Sep 2026).
Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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

Read the detailed description

For patients seeking long-term correction of excessive gingival displays, there are different treatment modalities. Both open flap and flapless with Piezo techniques showed improvement in the decrease in the amount of gingival display, while the flapless technique showed durable and satisfactory esthetics with less patient discomfort, less pain, inflammation and bleeding immediately after the procedure and through the follow up intervals. Also, the open flap technique showed satisfactory results to the patients but with more pain immediately after the procedure.

02

Conditions studied

  • Altered Passive Eruption

Keywords

  • Altered passive eruption
03

In context

Lead sponsor

Suez Canal University is the lead sponsor of 159 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Alcoholics and smokers.
  2. Patients with systemic illnesses or disorders that compromise wound healing.
  3. Patients on medications causing gingival enlargement.
  4. Pregnant women or lactating mothers.
  5. Patients with orthodontic appliances at the time of the surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Flapless Piezo-surgery

    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

  • Active comparator
    Conventional open flap crown lengthening

    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

  • Procedurepiezo-electric surgery

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

  • Procedureconventional open flap crown lengthening

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

06

What researchers measure

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.

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

Secondary outcomes

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

    Secondary outcome was comparing the morbidity of the open flap group to the minimally invasive flapless group, using visual analog scale (VAS score) ranging from 0 (no pain) to 10 (worst pain imaginable) at 24 hours and one week after the surgery.

    Time frame: 24 hours and one week after the surgery.

  2. Bleeding on probing

    Measurement of bleeding on probing using the Binary system: 0= no bleeding 1= bleeding on probing

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

  3. Gingival Index

    Gingival index (GI): according to (Löe, 1967) index system Scores (0-3) 0= Normal gingiva Natural coral pink gingiva with no inflammation 1. Mild inflammation, Slight changes in color, slight edema. No bleeding in probing. 2. Moderate inflammation, Redness, Edema and glazing. Bleeding upon Probing 3. Severe inflammation, Marked redness and edema/ ulceration/ tendency to bleed spontaneously

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

  4. Plaque Index

    using (Löe, 1967) index system, scores (0-3) 0= Absence of microbial plaque 1. Thin film of microbial plaque along the free gingival margin 2. Moderate accumulation of plaque in the sulcus 3. Large amount of plaque in the sulcus or pocket along the free gingival margin

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

  5. Clinical attachment level (CAL)

    Clinical attachment level (CAL) was measured in mm from the cemento enamel junction to the base of the gingival sulcus following the marked grooves.

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

  6. Pocket depth (PD)

    Pocket depth (PD) was measured in mm from the gingival margin to the base of the gingival sulcus following the marked grooves

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

  7. Width of keratinized tissue (WKT)

    Width of keratinized tissue (WKT) was measured in mm from the free gingival margin to the muco-gingival line following the marked grooves

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

  8. Relative bone level (RBL)

    Relative bone level (RBL) was measured in mm from the incisal end of the vacuum stent to the bone crest, guided by the fixed grooves. And was recorded preoperative and immediately after the surgery by bone sounding technique.

    Time frame: preoperative and immediately post-operative.

07

Study locations

1 site
  • periodontology clinic, faculty of dentistry Suez canal university
    Ismailia, Ismailia Governorate 41511, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07887438
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Feb 11, 2023
Primary completion
Nov 19, 2023
Completion
Apr 21, 2024
Last update
Oct 21, 2026

Study contacts

Shaimaa Mohammed Morsy, PHD in periodontology
study director · Suez Canal 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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