Effect of Botox Before Modified Lip Repositioning Repositioning Only in Relapse of the Excessive Gingival Display Within One Year

NCT06148961 | Unknown DMC

• 1 other identifier: 2023-2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Excessive Gingival Display

Outcome Measures

Primary Outcomes (1)

• Change in gingival display

  Using a 15-cm marked ruler (Antunes et al., 2022)

  3,6&12 months

Secondary Outcomes (1)

• Patient's satisfaction

  3,6 &12 months

Other Outcomes (1)

• Maintenance of reduction of gingival display

  3 , 6 & 12 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

botox prior to modified lip repostioning PROCEDURE

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

control group; intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cherine Emad Mahmoud Mohamed Hamada

Giza, 12566, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: February 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

EG (1)