NCT07575087

Brief Summary

This randomized controlled clinical trial aims to evaluate the clinical performance and patient-centered outcomes of dual digitally guided crown lengthening compared to the conventional surgical technique in the management of gummy smile caused by altered passive eruption (Type B1). A total of 18 patients will be randomly allocated into two groups: the control group will undergo conventional crown lengthening based on clinical measurements, while the intervention group will receive crown lengthening using a dual digitally fabricated surgical guide. The primary outcome is the gain in clinical crown length at 3 months. Secondary outcomes include operating time, pain perception, patient satisfaction, gingival margin stability, and periodontal clinical parameters. This study aims to determine whether digital guidance improves surgical accuracy, efficiency, and patient satisfaction compared to traditional techniques

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Gingival Overgrowth

Keywords

Crown LengtheningDigital Surgical GuideGuided Surgery

Outcome Measures

Primary Outcomes (1)

  • Gain in Clinical Crown Length

    Change in clinical crown length (mm), measured from the incisal edge to the gingival margin using a periodontal probe, to assess the effectiveness of crown lengthening procedures.

    Baseline and 3 months postoperatively

Secondary Outcomes (10)

  • Surgical Operating Time

    During surgery (intraoperative)

  • Postoperative Pain (VAS)

    24 hours, 7 days, and 14 days postoperatively

  • Patient Satisfaction (VAS)

    7 days and 3 months postoperatively

  • Relative Gingival Margin Level

    Baseline, 1 week, and 3 months postoperatively

  • Probing Depth

    Baseline and 3 months postoperatively

  • +5 more secondary outcomes

Study Arms (2)

Conventional Crown Lengthening

ACTIVE COMPARATOR

Participants in this group will undergo conventional surgical crown lengthening based on clinical evaluation and manual measurements. The procedure includes gingivectomy and osseous resection performed according to standard periodontal surgical protocols without the use of digital guidance.

Procedure: Conventional Crown Lengthening

Dual Digitally Guided Crown Lengthening

EXPERIMENTAL

Participants in this group will receive crown lengthening using a dual digitally fabricated surgical guide. The procedure is planned using digital smile design, intraoral scanning, and CBCT analysis to guide both soft tissue and bone resection, aiming to improve surgical precision and predictability.

Procedure: Dual Digitally Guided Crown Lengthening

Interventions

Conventional Crown LengtheningPROCEDURE

Conventional surgical crown lengthening performed based on clinical examination and manual measurements. The procedure includes gingival recontouring and osseous resection carried out according to standard periodontal surgical protocols without the use of digital guidance.

Conventional Crown Lengthening
Dual Digitally Guided Crown LengtheningPROCEDURE

Crown lengthening performed using a dual digitally fabricated surgical guide. The procedure is planned using digital smile design, intraoral scanning, and CBCT imaging to guide both soft tissue and bone resection, enhancing surgical accuracy and predictability.

Dual Digitally Guided Crown Lengthening

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients presenting with gummy smile due to altered passive eruption (Type B1)
  • Presence of at least 6 maxillary anterior teeth indicated for crown lengthening
  • Good oral hygiene and ability to maintain plaque control
  • Systemically healthy patients

You may not qualify if:

  • Poor oral hygiene
  • Smokers
  • Pregnancy or lactation
  • Systemic diseases affecting periodontal tissues
  • Previous periodontal surgery in the study area
  • Active periodontal disease
  • Presence of periapical pathology in the study area
  • Ongoing orthodontic treatment
  • Gummy smile due to skeletal or muscular causes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dental Medicine

Damascus, Syria

Location

Related Publications (5)

  • Pavone AF, Ghassemian M, Verardi S. Gummy Smile and Short Tooth Syndrome--Part 1: Etiopathogenesis, Classification, and Diagnostic Guidelines. Compend Contin Educ Dent. 2016 Feb;37(2):102-7; quiz 108-10.

    PMID: 26905089BACKGROUND

  • Marzadori M, Stefanini M, Sangiorgi M, Mounssif I, Monaco C, Zucchelli G. Crown lengthening and restorative procedures in the esthetic zone. Periodontol 2000. 2018 Jun;77(1):84-92. doi: 10.1111/prd.12208. Epub 2018 Mar 1.

    PMID: 29493814BACKGROUND

  • Malkinson S, Waldrop TC, Gunsolley JC, Lanning SK, Sabatini R. The effect of esthetic crown lengthening on perceptions of a patient's attractiveness, friendliness, trustworthiness, intelligence, and self-confidence. J Periodontol. 2013 Aug;84(8):1126-33. doi: 10.1902/jop.2012.120403. Epub 2012 Nov 9.

    PMID: 23137007BACKGROUND

  • Bynum J. Treatment of a "Gummy Smile": Understanding Etiology is Key to Success. Compend Contin Educ Dent. 2016 Feb;37(2):114-22.

    PMID: 26905090BACKGROUND

  • Carrera TMI, Freire AEN, de Oliveira GJPL, Dos Reis Nicolau S, Pichotano EC, Junior NVR, Pires LC, Pigossi SC. Digital planning and guided dual technique in esthetic crown lengthening: a randomized controlled clinical trial. Clin Oral Investig. 2023 Apr;27(4):1589-1603. doi: 10.1007/s00784-022-04780-8. Epub 2022 Nov 21.

    PMID: 36409356BACKGROUND

MeSH Terms

Conditions

Gingival Overgrowth

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Raghad Alrefaai, DDs

    Damascus University

    PRINCIPAL INVESTIGATOR

  • Razan Khattab, PhD

    Damascus University

    STUDY CHAIR

  • Saleh Al Kurdi, PhD

    Arab International University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

July 1, 2024

Primary Completion

October 15, 2025

Study Completion

February 25, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)