Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT07041541
Active, not recruitingNCT07041541ClinicalTrials.gov record

Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption.

Gummy Smile · Altered Passive Eruption of Teeth · Healthy Participants

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 60 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
22 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

When performing crown lengthening surgery, especially in the esthetic zone, the positional stability of gingival tissues is considered a prime important goal. The rebound of gingival margins after surgery can result in compromising the esthetic outcome and patient satisfaction. It was proven throughout the literature that there are many factors that may influence the stability of gingival margin position after surgery such as: the surgical technique being performed, experience of the clinician, periodontal phenotype and distance of flap with respect to the alveolar crest.

Read the full description

A "gummy smile" or excessive gingival display (EGD) is when at least 3-5 mm of gingiva is visible. It is viewed as unnatural or unsightly, and in order to have the best outcome, cosmetic periodontal recontouring is frequently necessary. It is considered the treatment of choice for excessive gingival display, or "Gummy smile,". Many causes of gummy smiles have been found, including altered passive eruption, short upper lip, dentoalveolar extrusion, abnormal vertical bone growth, and a combination of some of these.

Altered passive eruption is when the gingival margin is located incisal to the cervical convexity of the crown and away from the cemento-enamel junction of the tooth. It is considered the most frequent related factor, accounting for between 12.1 and 35.8% of excessive gingival display cases that have been identified, according to evidence.

Considering esthetic crown lengthening (ECL) surgery, the goal is to restore the gingival harmony and symmetry by reestablishing the proper clinical crown length. However, stability of the periodontal tissues after ECL is a crucial aspect that can be jeopardized the treatment outcome of the treated region. In particular, gingival margin rebound can impair aesthetics and have an impact on the health of periodontal tissue

Predicting the amount of tissue rebound after esthetic crown lengthening surgery is still controversial. According to literature, there is a tendency to have a gingival regrowth from the immediate postoperative level for up to 3 months. It has been also confirmed that rebound of gingival margin most likely occurs during the first three months following surgery. Another study found that the gingival margin had coronal migration may continue for up to 6-12 months after surgery.

Based on current evidence, gingival margin rebound is a major issue that happens after performing crown lengthening surgery. To avoid this, GingivalStat approach has been proposed to guide the tissue after surgery to remodel early at a predetermined position and avoid the re-growth of gingiva in a coronal direction. It appears to be producing earlier stability. The current study aims to investigate the influence of GingivalStat following crown lengthening versus conventional crown lengthening, in terms of stability of gingival margin.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Patients with Altered Passive Eruption Subtype B presenting altered alveolar bone crest-CEJ relationship according to Coslet's et al. classification.
2. Patients free of systemic diseases.
3. Patients aged between 18 to 60 years old.
4. Patients maintaining good oral hygiene with full-mouth plaque and bleeding scores \<15%.
5. Patients should be committed to the post-operative care regime, including oral hygiene practices, and follow-up visits.

Exclusion Criteria:

1. Areas in which the remaining amount of keratinized gingiva after the submarginal incision will be less than 3 mm.
2. Patients with periodontal disease.
3. Smokers.
4. Pregnant women.
5. Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radiotherapy)

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Triple masked
Interventional group (Gingival Stat approach -- Composite stops after ECL surgery)

Steps 1-6 as Active Comparator group + 7. Resin composite wil be placed on the cervical third of the teeth, following the CEJ anatomy, to act as a gingival stabilizer to guide the early remodelling of tissues.

8\. Removal of sutures and composite after two weeks.

Procedure: Esthetic Crown Lengthening using GingivalStat approach

Control group (Conventional ECL surgery)

1. Following the administration of local anaesthesia, a submarginal internal bevelled incision using 15c blade will be carried out, from canine to canine. The distance from the gingival margin will be based on how much soft tissue needs to be removed to meet the ideal tooth proportion.
2. Intrasulcular incision will be done in the buccal aspect and papilla region for removal of tissue collar.
3. A full thickness mucoperiosteal flap will be elevated using mucoperiosteal elevator, without bypassing the MGJ.
4. To obtain a 3 mm distance between CEJ and bone, osteoctomy wil be carried out from line angle to line angle using high speed hand piece with end-cutting bur.
5. Osteoplasty using round bur, maybe done to reduce bone thickness and obtain adequate anatomical profile.
6. After the flap is repositioned, interrupted sutures using Polypropylene 5-0 will be used to adapt and suture the flap in its new position.

Procedure: Esthetic Crown Lengthening

Esthetic Crown Lengthening PROCEDURE

Conventional Esthetic Crown Lengthening

Esthetic Crown Lengthening using GingivalStat approach PROCEDURE

Esthetic Crown Lengthening using GingivalStat approach (composite stops)

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Reduction in the gingival margin

Time frame: Baseline, immediate post operative, 2 weeks, 3 months and 6 months

Gingival margin position wil be measured using UNC periodontal probe + stent. Grooves will be made in the stent to standardize probe direction and localization. Each tooth will be assessed on the mesio-buccal, mid-buccal, and disto-buccal aspect at baseline, immediate post operative, 2 weeks, 3 months, and 6 months.

Stability of relative gingival margin position

Time frame: Baseline, immediate postoperative, 2 weeks, 3 months and 6 months

Gingival margin position will be measured using Intra-oral digital Scan (IOS). It will be measured at baseline, immediately after surgery, 2 weeks, 3 months and 6 months. Scans will be superimposed to detect all changes throughout the follow up period.

Secondary measures

Pink Esthetic Score by blinded assessment

Time frame: At 3 months and 6 months

It is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable is assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.

Postsurgical pain assessment

Time frame: At two weeks.

Readings will be recorded by the patient for the first 14 days after the surgery using the VAS which is a descriptive numerical rating scale of 0 to 10.

0 = No pain 1-3= Mild pain 4-6 = Moderate pain (bearable) 7-10 = Severe pain (unbearable)

Patient satisfaction

Time frame: Two weeks, three months and six months

A 3-item questionnaire will be given to the patients to be answered using a 7-point answer scale for assessing their satisfaction with the whole procedure and the results of the procedure performed.

Cost effectiveness

Time frame: At six months.

It will be calculated using an equation to correlate the procedural time, cost of the materials used against the clinical outcomes.

Procedural Time

Time frame: At the surgery

It will be recorded in minutes using a stopwatch to measure the difference in the procedural time between the two groups.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Faculty of Dentistry, Cairo UniversityCairo, EgyptStatus unknown

Study team and timeline

Lead sponsor
Cairo University
Study start
Oct 8, 2024 Actual
Primary completion
Dec 1, 2026 Estimated
Study completion
Dec 1, 2026 Estimated
First posted
Jun 27, 2025 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Clinical Evaluation of Gingivalstat Approach Compared to Conventional Esthetic Crown Lengthening on the Stability of The Gingival Margin in Patients With Altered Passive Eruption. A Randomized Clinical Trial.

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026