Effect of Botox Before Modified Lip Repositioning Repositioning Only in Relapse of the Excessive Gingival Display Within One Year (Randomized Controlled Clinical Trial)

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06148961

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The growing interest of patients in esthetic procedures, as well as the development of less invasive protocols in dentistry, has promoted the development of treatment plans that include stability, harmony, and function in orofacial rehabilitation.

Poor esthetics interfere with an individual's personal, social, and professional relationships and is an individual consideration that varies according to the patient's age, time, region, and culture concerning what is considered beautiful. (Flores-Mir et al., 2004)

Condition or Disease	Intervention/Treatment	Phase
Excessive Gingival Display	Procedure: botox prior to modified lip repostioning	N/A

Detailed Description

People are increasingly being inspired to get more corrective and cosmetic surgeries as an esthetic smile becomes a more fundamental component of what it means to be beautiful.

There are several variables that affect how appealing and esthetic a smile is (Bhuvaneswaran, 2010) Esthetic perception varies according to cultural, societal, environmental, and individual factors like experience and educational level (Yang et al., 2019) Previous studies have shown that a smile with less gingival display (GD) is viewed as more beautiful, with dental professionals being more critical of gingival presentation than laypeople (Negruțiu et al., 2022) According to research by several authors, the ideal GD ranges from 1 to 3 mm (Negruțiu et al., 2022)(Brizuela M, 2023) While many factors influence how pleasant a smile is seen, excessive GD (EGD), sometimes referred to as a gummy smile, is regarded as a key factor in smile analysis and one of the main issues connected to an unsatisfactory dental smile. (Maniyar et al., 2018)

To reduce the relapse associated with repositioning surgery and to provide a lasting treatment without the need for reapplication, as in the case of the toxin, a combined treatment using the toxin preoperatively was considered.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Botox Before Modified Lip Repositioning and Modified Lip Repositioning Only in Relapse of the Excessive Gingival Display Within One Year (Randomized Controlled Clinical Trial)

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Oct 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group botox injection prior to surgical intervention by 5 to 10 days A surgical marker was used to outline the boundaries of the surgical incision region. the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions. A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture	Procedure: botox prior to modified lip repostioning botox injection prior to surgical intervention by 5 to 10 days A surgical marker was used to outline the boundaries of the surgical incision region. the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions. A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture
Active Comparator: control group A surgical marker was used to outline the boundaries of the surgical incision region. the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions. A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture	Procedure: botox prior to modified lip repostioning botox injection prior to surgical intervention by 5 to 10 days A surgical marker was used to outline the boundaries of the surgical incision region. the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions. A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

Arm

Intervention/Treatment

Experimental: intervention group

botox injection prior to surgical intervention by 5 to 10 days A surgical marker was used to outline the boundaries of the surgical incision region. the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions. A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

Procedure: botox prior to modified lip repostioning

Active Comparator: control group

A surgical marker was used to outline the boundaries of the surgical incision region. the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions. A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

Procedure: botox prior to modified lip repostioning

Outcome Measures

Primary Outcome Measures

Change in gingival display [3,6&12 months]
Using a 15-cm marked ruler (Antunes et al., 2022)

Secondary Outcome Measures

Patient's satisfaction [3,6 &12 months]
Survey (Silva et al., 2013)
Maintenance of reduction of gingival display [3 , 6 & 12 months]
callipper

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients that is not satisfied with his smile having excessive gingival display
Adult Age ≥ 21 years.
Systemically and periodontally Healthy patients.
had gingival exposure greater than 3 mm when smiling
had a hyperactive upper lip with or without other causes of EGD (lip displacement ≥ 9 mm) before botox & ≥ 3mm after.
Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria:

• smoking
pregnancy or lactation
Systemic diseases; neuromuscular,neurological, or psychological disorders or consumption of controlled medication
Patients having medical condition or any drugs that could affect healing
Patients with systemic condition that can't undergo minor oral surgery
Patient allergic to Botox or multiple allergic conditions
have history of previous Botox injection
periodontal disease
excessive gingival display at rest
those who declined the informed consent or who did not consent to the risks described.
Those who have deviate smile

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cherine Emad Mahmoud Mohamed Hamada, assistant lecturer, October University for Modern Sciences and Arts

ClinicalTrials.gov Identifier:

NCT06148961

Other Study ID Numbers:

2023-2025

First Posted:

Nov 28, 2023

Last Update Posted:

Nov 28, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Recurrence

Study Results

No Results Posted as of Nov 28, 2023