Micro-surgical Treatment of Gummy Smile

NCT ID: NCT04401826

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-06

Study Completion Date

2022-06-06

Brief Summary

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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

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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

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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The conventional approach

Conventionnal ECL using piezosurgery and microsurgical tools

Group Type EXPERIMENTAL

Micro-surgical crown lengthening approach using Piezosurgery

Intervention Type PROCEDURE

excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation.

The intervention approach:

Conventionnal ECL with tunneling using piezosurgery and microsurgical tools

Group Type ACTIVE_COMPARATOR

Tunneling micro-surgical crown lengthening approach using piezo-surgery

Intervention Type PROCEDURE

excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Marie-line Sherif Sourour

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Oral and Dental Medecine-CU

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PER3-3-1

Identifier Type: -

Identifier Source: org_study_id

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