Altered Passive EruptionPiezo-GumNCT07887438
Comparing Two Techniques to Treat Gummy Smile Patients: Flapless Piezo-surgery Versus Conventional Open Flap Surgery.
A study testing piezo-electric surgery and conventional open flap crown lengthening in people with Altered Passive Eruption, run by Suez Canal University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Altered Passive Eruption
- What is being tested?
- piezo-electric surgery and conventional open flap crown lengthening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Feb 2023to 21 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
periodontology clinic, faculty of dentistry Suez canal university
Ismailia, Ismailia Governorate, 41511
About this study
Official title: Assessment of Flapless Piezo-surgery Technique Versus Conventional Open Flap Technique for Aesthetic Crown Lengthening: A Randomized Controlled Clinical Trial
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:
Read more
"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.
- Conditions
- Altered Passive Eruption
- Being tested
- piezo-electric surgery, conventional open flap crown lengthening
- Keywords
- Altered passive eruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piezo-electric surgeryProcedure or surgery
Flapless piezo-surgery technique used for aesthetic crown lengthening in patients with gummy smile
conventional open flap crown lengtheningProcedure or surgery
conventional open flap technique used for aesthetic crown lengthening in patients with gummy smile
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: conventional open flap crown lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 24 hours and one week after the surgery.
Bleeding on probing
Measurement of bleeding on probing using the Binary system:
0= no bleeding
1= bleeding on probing
Measured: Baseline, 1 week, 3 months and 6 months post-operatively.
Gingival Index
Gingival index (GI): according to (Löe, 1967) index system Scores (0-3) 0= Normal gingiva Natural coral pink gingiva with no inflammation
- Mild inflammation, Slight changes in color, slight edema. No bleeding in probing.
- Moderate inflammation, Redness, Edema and glazing. Bleeding upon Probing
- Severe inflammation, Marked redness and edema/ ulceration/ tendency to bleed spontaneously
Measured: Baseline, 1 week, 3 months and 6 months post-operatively.
Plaque Index
using (Löe, 1967) index system, scores (0-3) 0= Absence of microbial plaque
- Thin film of microbial plaque along the free gingival margin
- Moderate accumulation of plaque in the sulcus
- Large amount of plaque in the sulcus or pocket along the free gingival margin
Measured: Baseline, 1 week, 3 months and 6 months post-operatively.
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.
Measured: Baseline, 1 week, 3 months and 6 months post-operatively.
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
Measured: Baseline, 1 week, 3 months and 6 months post-operatively.
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
Measured: Baseline, 1 week, 3 months and 6 months post-operatively.
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.
Measured: preoperative and immediately post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start11 Feb 2023
- Primary completion19 Nov 2023
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Altered Passive EruptionStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaimaa Mohammed Morsy, PHD in periodontology, Study director, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887438
- Sponsor's protocol ID
- 590/2022
- Acronym
- Piezo-Gum
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Flapless Piezo-surgery Technique Versus Conventional Open Flap Technique for Aesthetic Crown Lengthening: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07887438
- Acronym / sponsor ID
- Piezo-Gum / 590/2022
- Conditions
- Altered Passive Eruption
- Keywords
- Altered passive eruption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 11 Feb 2023 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flapless Piezo-surgery | Experimental | Procedure: piezo-electric surgery15 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. |
| Conventional open flap crown lengthening | Active comparator | Procedure: conventional open flap crown lengthening15 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| piezo-electric surgeryFlapless piezo-surgery technique used for aesthetic crown lengthening in patients with gummy smile | Procedure or surgery | Flapless Piezo-surgery |
| conventional open flap crown lengtheningconventional open flap technique used for aesthetic crown lengthening in patients with gummy smile | Procedure or surgery | Conventional open flap crown lengthening |
Primary outcome
The primary outcome was clinical crown lengthening.
Time frame: Baseline, 1 week, 3 months and 6 months post-operatively.
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.
8 secondary outcomes
Secondary outcome was comparing the morbidity of the open flap group to the minimally invasive flapless group
Time frame: 24 hours and one week after the surgery.
Bleeding on probing
Time frame: Baseline, 1 week, 3 months and 6 months post-operatively.
Gingival Index
Time frame: Baseline, 1 week, 3 months and 6 months post-operatively.
Plaque Index
Time frame: Baseline, 1 week, 3 months and 6 months post-operatively.
Clinical attachment level (CAL)
Time frame: Baseline, 1 week, 3 months and 6 months post-operatively.
Pocket depth (PD)
Time frame: Baseline, 1 week, 3 months and 6 months post-operatively.
Width of keratinized tissue (WKT)
Time frame: Baseline, 1 week, 3 months and 6 months post-operatively.
Relative bone level (RBL)
Time frame: preoperative and immediately post-operative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Altered Passive Eruption
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Laser-Assisted Minimally Invasive Esthetic Crown Lengthening Using Flapless vs. Tunneled Flap Approach
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Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaimaa Mohammed Morsy, PHD in periodontology study director
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing piezo-electric surgery and conventional open flap crown lengthening in people with Altered Passive Eruption, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was clinical crown lengthening. (time frame: Baseline, 1 week, 3 months and 6 months post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.