NCT03804281

Brief Summary

the study compare gingival margin stability following conventional approach versus microsurgical approach of esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.In management of patients with short clinical crowns in the upper anterior region, there is no difference in gingival margin stability between conventional and microsurgical approaches of esthetic crown lengthening.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Status
unknown

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

First Submitted

Initial submission to the registry

January 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

January 11, 2019

Last Update Submit

January 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mid-buccal gingival margin level

    periodontal probe with William's graduation will be used to measure the distance from the CEJ to the gingival margin at the mid-buccal surface

    6 months

Secondary Outcomes (3)

  • Pink Esthetic Score (PES)

    6 months

  • Post-Surgical swelling

    7days

  • Post-Surgical Patient Satisfaction: 3-item questionnaire

    6 months

Study Arms (2)

Test group

EXPERIMENTAL

esthetic crown lengthening with microsurgical approach

Procedure: Test group

Control group

ACTIVE COMPARATOR

esthetic crown lengthening with conventional approach.

Procedure: Control group

Interventions

Test groupPROCEDURE

The surgery will be done with the use of 4x magnification loop, the knives are micro blades and micro-sutures 7//0 used with the microsurgical instruments kit

Test group
Control groupPROCEDURE

esthetic crown lengthening with conventional approach with an internal bevel incision, following CEJ anatomy, this will be followed by an intra-sulcular incision, removal of the strip of outlined marginal gingiva and elevation of a mucoperiosteal flap to the level of the alveolar bone crest.

Control group

Eligibility Criteria

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

You may qualify if:

  • Patients with healthy systemic condition.
  • Adult patients ˃ 18 years old.
  • The presence of the six upper anterior teeth.
  • Absence of sites with attachment loss and probing depth (PD) \>3 mm
  • Keratinized gingiva of at least 2mm width.
  • Compliance with good oral hygiene.
  • Patients accepts 6-months follow-up period (cooperative patients).
  • Patients provides an informed consent

You may not qualify if:

  • Gummy smile with normal tooth proportions
  • Presence of prosthetic crowns
  • Extensive restorations
  • Extensive incisal edge attrition.
  • Misalignment on maxillary anterior teeth.
  • Smokers ˃ 10 cigarettes / day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

February 1, 2019

Primary Completion

January 1, 2020

Study Completion

August 1, 2020

Last Updated

January 18, 2019

Record last verified: 2019-01