Comparing Two Techniques to Treat Gummy Smile Patients: Flapless Piezo-surgery Versus Conventional Open Flap Surgery.
Piezo-Gum
Assessment of Flapless Piezo-surgery Technique Versus Conventional Open Flap Technique for Aesthetic Crown Lengthening: A Randomized Controlled Clinical Trial
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2024
CompletedFirst Submitted
Initial submission to the registry
September 21, 2026
CompletedFirst Posted
Study publicly available on registry
October 21, 2026
CompletedOctober 21, 2026
September 1, 2026
9 months
September 21, 2026
October 14, 2026
Conditions
Keywords
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
EXPERIMENTAL15 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 COMPARATOR15 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.
Interventions
Flapless piezo-surgery technique used for aesthetic crown lengthening in patients with gummy smile
conventional open flap technique used for aesthetic crown lengthening in patients with gummy smile
Eligibility Criteria
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shaimaa Mohammed Morsy, PHD in periodontology
Suez Canal University
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