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NCT Number: NCT07041541

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

About this study

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 can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Esthetic Crown Lengthening

Procedure

Conventional Esthetic Crown Lengthening

Esthetic Crown Lengthening using GingivalStat approach

Procedure

Esthetic Crown Lengthening using GingivalStat approach (composite stops)

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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