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

NCT07041541 | Active Not Recruiting DMC

• 1 other identifier: Composite stops after ECL
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gummy Smile; Altered Passive Eruption of Teeth; Healthy Participants

Keywords

Gummy Smile; Altered Passive Eurption; Esthetic Crown Lengthening; GingivalStat Approach

Outcome Measures

Primary Outcomes (2)

• Reduction in the gingival margin

  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.

  Baseline, immediate post operative, 2 weeks, 3 months and 6 months

• Stability of relative gingival margin position

  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.

  Baseline, immediate postoperative, 2 weeks, 3 months and 6 months

Secondary Outcomes (5)

• Pink Esthetic Score by blinded assessment

  At 3 months and 6 months

• Postsurgical pain assessment

  At two weeks.

• Patient satisfaction

  Two weeks, three months and six months

• Cost effectiveness

  At six months.

• Procedural Time

  At the surgery

Study Arms (2)

Interventional group (Gingival Stat approach -- Composite stops after ECL surgery)

EXPERIMENTAL

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)

ACTIVE COMPARATOR

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

Interventions

Esthetic Crown Lengthening PROCEDURE

Conventional Esthetic Crown Lengthening

Control group (Conventional ECL surgery)

Esthetic Crown Lengthening using GingivalStat approach PROCEDURE

Esthetic Crown Lengthening using GingivalStat approach (composite stops)

Interventional group (Gingival Stat approach -- Composite stops after ECL surgery)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: October 8, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-06

Locations

EG (1)