Micro-surgical Treatment of Gummy Smile

Study Overview
=================
Brief Summary
-----------------
Compare pain response following microsurgical conventional flap approach using Piezosurgery versus flapless approach for esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.

Detailed Description
-----------------
The conventional approach: Anesthesia will be given followed by bone sounding using William graduated periodontal probe and measuring the pocket depth (using magnification loupes and microsurgical blades) Marking the bleeding points An internal bevel incision is made followed afterwards by a sulcular incision. The gingival collar is eliminated. Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery and an apical position of the bone 2-3mm beyond CEJ. Mattress suture (6.0) is made The intervention approach: Surgery is done the same as in the conventional approach but without opening a flap, gaining access via a tunneling instrument and piezo tips for osteoplasty

Official Title
-----------------
Evaluation of Pain Following Microsurgical Esthetic Crown Lengthening Using Flap Vs. Flapless Piezo-surgical Approach: A Randomized Controlled Clinical Trial

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Tunneling micro-surgical crown lengthening approach using piezo-surgery
* Procedure: Micro-surgical crown lengthening approach using Piezosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with healthy systemic condition. Adult patients ˃ 18 years old. The presence of the six upper anterior teeth. Patients who have short clinical crowns due to altered passive eruption classified as Type I subclass B (Coslet, Vanarsdall and Weisgold, 1977). Absence of sites with attachment loss and probing depth (PD) >3 mm. Keratinized gingiva of at least 2mm width (Pontoriero and Carnevale, 2001). Compliance with good oral hygiene. Patients accepts 6-months follow-up period (cooperative patients). Patients provides an informed consent. Exclusion Criteria: Presence of prosthetic crowns Extensive restorations Extensive incisal edge attrition. Smokers ˃ 10 cigarettes / day Pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The conventional approach<br>Conventionnal ECL using piezosurgery and microsurgical tools | Procedure: Micro-surgical crown lengthening approach using Piezosurgery<br>* excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation.<br>|
| Active Comparator: The intervention approach:<br>Conventionnal ECL with tunneling using piezosurgery and microsurgical tools | Procedure: Tunneling micro-surgical crown lengthening approach using piezo-surgery<br>* excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS | Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative | 48 hours | 

Secondary 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 a prefabricated grooved stent vertically- to the level of the gingival margin at the mid-buccal surface (measured at baseline, 3 and 6 months postoperatively) | 6 months | 
| Post-Surgical Patient Satisfaction. | Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. ) | 6 months | 
| Pink Esthetic Score | 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. All other variables will be assessed by comparison to a reference tooth. | 6 months | 
| Post-Surgical swelling | 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. (Assessed in day 7 and 14 postoperatively) | 14 days |