Micro-surgical Treatment of Gummy Smile

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: Tunneling micro-surgical crown lengthening approach using piezo-surgery; Procedure: Micro-surgical crown lengthening approach using Piezosurgery

• Registration Number: NCT04401826
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-26
• Study Start: 2020-09-06
• Primary Completion: 2021-12-06
• Study Completion: 2022-06-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Patients with healthy systemic condition.
2. Adult patients ˃ 18 years old.
3. The presence of the six upper anterior teeth.
4. Patients who have short clinical crowns due to altered passive eruption classified as Type I subclass B (Coslet, Vanarsdall and Weisgold, 1977).
5. Absence of sites with attachment loss and probing depth (PD) >3 mm.
6. Keratinized gingiva of at least 2mm width (Pontoriero and Carnevale, 2001).
7. Compliance with good oral hygiene.
8. Patients accepts 6-months follow-up period (cooperative patients).
9. Patients provides an informed consent.

Exclusion Criteria

1. Presence of prosthetic crowns
2. Extensive restorations
3. Extensive incisal edge attrition.
4. Smokers ˃ 10 cigarettes / day
5. Pregnant females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The intervention approach:	Tunneling micro-surgical crown lengthening approach using piezo-surgery	Conventionnal ECL with tunneling using piezosurgery and microsurgical tools
The conventional approach	Micro-surgical crown lengthening approach using Piezosurgery	Conventionnal ECL using piezosurgery and microsurgical tools

Primary Outcome Measures

Name	Time	Method
Pain VAS	48 hours	Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative

Secondary Outcome Measures

Name	Time	Method
Post-Surgical swelling	14 days	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)
Post-Surgical Patient Satisfaction.	6 months	Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )
Mid-buccal gingival margin level	6 months	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)
Pink Esthetic Score	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. All other variables will be assessed by comparison to a reference tooth.

Trial Locations

Locations (1)

Faculty of Oral and Dental Medecine-CU; 🇪🇬 Cairo, Egypt