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Completed

NCT Number: NCT04401826

Micro-surgical Treatment of Gummy Smile

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medecine-CU

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tunneling micro-surgical crown lengthening approach using piezo-surgery

Procedure

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

Micro-surgical crown lengthening approach using Piezosurgery

Procedure

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

Primary outcomes

  1. Pain VAS

    Time frame: 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 outcomes

  1. Mid-buccal gingival margin level

    Time frame: 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)

  2. Post-Surgical Patient Satisfaction.

    Time frame: 6 months

    Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )

  3. Pink Esthetic Score

    Time frame: 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.

  4. Post-Surgical swelling

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 26, 2020
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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