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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedStudy Start
First participant enrolled
September 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2022
CompletedJuly 5, 2023
July 1, 2023
1.2 years
May 21, 2020
July 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Mid-buccal gingival margin level
6 months
Post-Surgical Patient Satisfaction.
6 months
Pink Esthetic Score
6 months
Post-Surgical swelling
14 days
Study Arms (2)
The conventional approach
EXPERIMENTALConventionnal ECL using piezosurgery and microsurgical tools
The intervention approach:
ACTIVE COMPARATORConventionnal ECL with tunneling using piezosurgery and microsurgical tools
Interventions
excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling
excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Presence of prosthetic crowns
- Extensive restorations
- Extensive incisal edge attrition.
- Smokers ˃ 10 cigarettes / day
- Pregnant females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Oral and Dental Medecine-CU
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 21, 2020
First Posted
May 26, 2020
Study Start
September 6, 2020
Primary Completion
December 6, 2021
Study Completion
June 6, 2022
Last Updated
July 5, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share