- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334015
Treatment of Excessive Gingival Display (Lip Repositioning and Z Plasty)
Assessment of Modified Lip Repositioning Surgery and Z Plasty Frenectomy for Treatment of Excessive Gingival Display
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Excessive gingival display is a cosmetic problem where it is usually managed by different approaches such as lip repositioning.
Aim: Is to evaluate clinically the postoperative outcomes of the Z plasty frenectomy technique in comparison to modified lip repositioning surgery Methodology: The clinical study will include 16 patients with gummy smile divided into two groups equally and randomly according to technique using www.randomizer.org.
Group 1: will be treated with conventional modified lip repositioning technique and the labial frenum will be left intact.
Group 2: will be treated with z plasty frenectomy. Clinical follow up will be at 1,3, 6 and 9 months.
Clinical evaluation will be done through using (VAS). It will be used to measure patient satisfaction through pain killer scale . - Likert scale to measure patient satisfaction - Periodontal probe will be used to measure the relapse. Also signs of infection will be recorded.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ismailia, Egypt
- Suez Canal University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients aged 18 to 30 years
- ASA physical status I or II
- Presence of excessive gingival display (gummy smile)
- Indication for surgical treatment of excessive gingival display
- Willingness to participate and attend follow-up visits
Exclusion Criteria:
- Poor oral hygiene
- Patients with active acute infection
- Patients with poor oral habits
- Pregnant or lactating women
- Heavy smokers
- Alcohol or drug addicts
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: study group: z plasty frenectomy
Participants in the study group will be treated with Z- plasty frenectomy and will be followed up for 9 months
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Z-plasty frenectomy is a surgical procedure in which the frenum is released and rearranged using a Z-shaped incision.
This technique helps improve tissue mobility and reduce tension.
The procedure is performed under local anesthesia"
Other Names:
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Experimental: control group : modified lip repositioning
Participants in the control group will undergo modified lip repositioning with a follow-up period of 9 months.
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"Modified lip repositioning is a minimally invasive surgical technique used to reduce excessive gingival display.
The procedure involves removing a small strip of mucosa and repositioning the upper lip to limit its upward movement during smiling.
It is performed under local anesthesia ."
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Gingival Display (mm)
Time Frame: Up to 9 months
|
Gingival display will be assessed in millimeters using standardized clinical photographs taken at maximum smile.
Measurements will be performed using a periodontal probe to determine the vertical distance between the inferior border of the upper lip and the gingival margin of the maxillary central incisors.
A reduction in gingival display indicates improvement, while an increase indicates relapse.
Measurements will be recorded at baseline and during follow-up visits.
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Up to 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain score
Time Frame: Up to 9 months
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Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Lower scores indicate less pain.
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Up to 9 months
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Patient Satisfaction Score
Time Frame: Up to 9 months
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Patient satisfaction will be evaluated using a numerical rating scale from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates maximum satisfaction.
Higher scores indicate greater satisfaction.
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Up to 9 months
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Signs of infection
Time Frame: Up to 9 months
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Postoperative infection will be assessed clinically based on the presence of signs such as redness, swelling, pain, discharge, or delayed healing at the surgical site.
The outcome will be recorded as present or absent.
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Up to 9 months
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Surgical Time
Time Frame: During surgery
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Surgical time will be measured in minutes from the initial incision to the completion of wound closure.
Shorter surgical time indicates a more efficient procedure.
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During surgery
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024/857
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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