Clinical Evaluation of Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03804281

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Feb 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Mid-buccal gingival margin level [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

Pink Esthetic Score (PES) [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
Post-Surgical swelling [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).
Post-Surgical Patient Satisfaction: 3-item questionnaire [6 months]
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed elshafie mohamed tawfiq hassan, Dentist, Cairo University

ClinicalTrials.gov Identifier:

NCT03804281

Other Study ID Numbers:

Dentaris192018

First Posted:

Jan 15, 2019

Last Update Posted:

Jan 18, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 18, 2019