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Clinical Evaluation of Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening

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ClinicalTrials.gov Identifier: NCT03804281
Recruitment Status : Unknown
Verified January 2019 by Mohamed elshafie mohamed tawfiq hassan, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed elshafie mohamed tawfiq hassan, Cairo University

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.

Condition or disease Intervention/treatment Phase
Gummy Smile Procedure: Test group Procedure: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Gingival Margin Stability Following Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : August 1, 2020

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.




Primary Outcome Measures :
  1. Mid-buccal gingival margin level [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Pink Esthetic Score (PES) [ Time Frame: 6 months ]
    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

  2. Post-Surgical swelling [ Time Frame: 7days ]
    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).

  3. Post-Surgical Patient Satisfaction: 3-item questionnaire [ Time Frame: 6 months ]
    A 3-item questionnaire is asked and the patients shall use a 7-point answer scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Mohamed elshafie mohamed tawfiq hassan, Dentist, Cairo University
ClinicalTrials.gov Identifier: NCT03804281    
Other Study ID Numbers: Dentaris192018
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No