Back to resultsMicro-surgical Treatment of Gummy Smile
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tunneling micro-surgical crown lengthening approach using piezo-surgery
Micro-surgical crown lengthening approach using Piezosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
- Faculty of Oral and Dental Medecine-CU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The conventional approach
The intervention approach:
Arm Description
Conventionnal ECL using piezosurgery and microsurgical tools
Conventionnal ECL with tunneling using piezosurgery and microsurgical tools
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Post-Surgical Patient Satisfaction.
Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04401826
Brief Title
Micro-surgical Treatment of Gummy Smile
Official Title
Evaluation of Pain Following Microsurgical Esthetic Crown Lengthening Using Flap Vs. Flapless Piezo-surgical Approach: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2020 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
June 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The conventional approach
Arm Type
Experimental
Arm Description
Conventionnal ECL using piezosurgery and microsurgical tools
Arm Title
The intervention approach:
Arm Type
Active Comparator
Arm Description
Conventionnal ECL with tunneling using piezosurgery and microsurgical tools
Intervention Type
Procedure
Intervention Name(s)
Tunneling micro-surgical crown lengthening approach using piezo-surgery
Intervention Description
excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling
Intervention Type
Procedure
Intervention Name(s)
Micro-surgical crown lengthening approach using Piezosurgery
Intervention Description
excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation.
Primary Outcome Measure Information:
Title
Pain VAS
Description
Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Mid-buccal gingival margin level
Description
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)
Time Frame
6 months
Title
Post-Surgical Patient Satisfaction.
Description
Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )
Time Frame
6 months
Title
Pink Esthetic Score
Description
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.
Time Frame
6 months
Title
Post-Surgical swelling
Description
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)
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Oral and Dental Medecine-CU
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Micro-surgical Treatment of Gummy Smile
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