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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04401826
Enrollment
24
Registered
2020-05-26
Start date
2020-09-06
Completion date
2022-06-06
Last updated
2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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

Interventions

PROCEDURETunneling 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

PROCEDUREMicro-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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain VAS48 hoursVisual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative

Secondary

MeasureTime frameDescription
Mid-buccal gingival margin level6 monthsPeriodontal 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)
Post-Surgical Patient Satisfaction.6 monthsNumerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )
Pink Esthetic Score6 monthsThe 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.
Post-Surgical swelling14 daysAbsent: 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026