Micro-surgical Treatment of Gummy Smile

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Micro-surgical crown lengthening approach using Piezosurgery; Procedure: Tunneling micro-surgical crown lengthening approach using piezo-surgery

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Oral and Dental Medecine-CU

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2020
• Primary Completion (Actual): December 6, 2021
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: PER3-3-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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