NCT07762482

Brief Summary

This prospective, single-group interventional study will evaluate the stability of periodontal tissues after esthetic periodontal surgery for the correction of altered passive eruption in individuals with excessive gingival display. Ten adult participants with excessive gingival display associated with altered passive eruption and involvement of the alveolar bone will be included. Participants will undergo esthetic crown-lengthening surgery consisting of gingivectomy and osseous recontouring. Periodontal clinical measurements, intraoral digital scans, cone-beam computed tomography, standardized photographs, and patient-reported outcomes will be obtained before surgery and during follow-up. Clinical and three-dimensional tissue changes, esthetic perception, satisfaction, and oral health-related quality of life will be evaluated for up to 12 months after treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress10%
Aug 2026Feb 2028

First Submitted

Initial submission to the registry

August 8, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

1.5 years

First QC Date

August 8, 2026

Last Update Submit

August 12, 2026

Conditions

Keywords

Gummy SmileEsthetic Crown LengtheningGingivectomyOsseous SurgeryPeriodontal Plastic SurgeryPeriodontal Tissue StabilityIntraoral Scanning

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Clinical Crown Length

    Clinical crown length will be recorded in millimeters. The mean change from baseline will be calculated at each postoperative assessment to evaluate the stability of the surgical outcome over time.

    Baseline, 2 weeks, 3 months, 6 months, and 12 months after surgery

Secondary Outcomes (6)

  • Mean Change From Baseline in the Distance Between the Cementoenamel Junction and Alveolar Bone Crest

    Baseline, 3 months, 6 months, and 12 months after surgery

  • Mean Change From Baseline in Gingival Thickness

    Baseline, 3 months, 6 months, and 12 months after surgery

  • Mean Change From Baseline in Alveolar Bone Thickness

    Baseline, 3 months, 6 months, and 12 months after surgery

  • Three-Dimensional Change in Gingival Soft Tissues

    Baseline, 3 months, 6 months, and 12 months after surgery

  • Change in Oral Health-Related Quality of Life Assessed by OHIP-14

    Baseline, 3 months, 6 months, and 12 months after surgery

  • +1 more secondary outcomes

Study Arms (1)

Esthetic Crown-Lengthening Surgery

EXPERIMENTAL

Participants with excessive gingival display associated with altered passive eruption and alveolar bone involvement will undergo esthetic crown-lengthening surgery consisting of gingivectomy and osseous recontouring. Flap elevation may be performed when indicated according to the periodontal phenotype and local anatomical characteristics.

Procedure: Esthetic Crown-Lengthening Surgery

Interventions

Esthetic periodontal surgery will be performed to correct altered passive eruption. Gingival tissue will be removed by an internal bevel gingivectomy. Osseous recontouring will then be performed to establish an adequate relationship between the cementoenamel junction and the alveolar bone crest. Depending on the periodontal phenotype and anatomical characteristics, osseous recontouring may be performed with or without flap elevation.

Esthetic Crown-Lengthening Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with an esthetic complaint related to excessive gingival display.
  • Diagnosis of altered passive eruption as one of the etiologic factors associated with excessive gingival display.
  • Altered passive eruption involving the alveolar bone.

You may not qualify if:

  • Current orthodontic treatment.
  • Active periodontal disease.
  • Systemic conditions that contraindicate periodontal surgical procedures, including uncontrolled autoimmune diseases.
  • Use of medications that may interfere with the inflammatory response or wound healing, including corticosteroids or immunosuppressive agents.
  • Current smokers.
  • Former smokers who discontinued smoking less than 12 months before enrollment.
  • Pregnant or breastfeeding individuals.
  • Excessive gingival display primarily associated with lip hypermobility or vertical maxillary excess without concomitant altered passive eruption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry of Ribeirão Preto, University of Sao Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

RECRUITING

Central Study Contacts

Edgar Daniel Vargas Quiroga, DDS, MSc

CONTACT

Arthur Belem Novaes Jr, DDS, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive the same esthetic periodontal surgical intervention and will be followed longitudinally for 12 months. Outcomes will be compared with each participant's baseline measurements.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2026

First Posted

August 13, 2026

Study Start

August 10, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

August 17, 2026

Record last verified: 2026-08

Locations