Clinical Evaluation of Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening

Clinical Evaluation of Gingival Margin Stability Following Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening

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.

Study Overview

• Status: Unknown
• Conditions: Gummy Smile
• Intervention / Treatment: Procedure: Test group; Procedure: Control group

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; esthetic crown lengthening with microsurgical approach	Procedure: Test group; 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
Active Comparator: Control group; esthetic crown lengthening with conventional approach.	Procedure: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink Esthetic Score (PES)	The PES 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 shall be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence	6 months
Post-Surgical swelling	will be evaluated post-surgically with Verbal Rating Scale with words ranging from (absent-slight-moderate-intense) Absent (no swelling), Slight (intraoral swelling at the operated area), Moderate (moderate intraoral swelling at the operated area) and Intense (intensive extra oral swelling extending beyond the operated area).	7days
Post-Surgical Patient Satisfaction: 3-item questionnaire	A 3-item questionnaire is asked and the patients shall use a 7-point answer scale	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Dentaris192018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No