Evaluating Lip Repositioning for the Treatment of Excess Gingival Display With and Without Pretreatment With Botox

NCT04030767 | Unknown Phase 1

• 1 other identifier: 2261986
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Since the introduction of the lip repositioning procedure by a number of modifications to the technique have been introduced. All these modifications were made to prevent the main complication of lip repositioning surgeries 'relapse'. Relapse was found to occur in 8% of the cases treated . Botox injections have been suggested as a possible treatment for cases with relapse Botox acts by blocking muscular activity, however, Botulinum toxin technique has a transitory effect (6-7 months). . By combining Botox as a pretreatment and lip repositioning surgery, Botox injections maybe a useful adjunct in improving and stabilizing the results of achieved, by paralyzing the muscles during the healing period. There are no studies, to the investigator's knowledge, exploring the use of botox combined with lip repositioning to decrease muscle pull and therefore decrease the relapse.

Conditions

Gingival Overgrowth

Outcome Measures

Primary Outcomes (1)

• change in amount of gingival display

  Amount of gingival display (from the inferior border of the upper lip vermillion border to the gingival margin of the central incisor) will be assessed from clinical photographs obtained during active smile, with a mm ruler in place

  recorded at baseline, 3, 6 ,9 months and 1 year

Secondary Outcomes (1)

• Patient satisfaction: quesionnaire

  o The level of satisfaction during the followed periods (after two weeks, after two months, after six months)

Study Arms (2)

lip repositioning technique with Botox injection.

EXPERIMENTAL

Botulinum toxin produces partial chemical denervation of the muscle resulting in localized reduction in muscle activity (Binder et al., 1998). Therefore, the technique is a useful adjunct in the esthetic improvement of the smile and provides better results when combined with resective gingival surgery(Pedron \& Mangano, 2018).

Drug: Botox Injectable Product

lip repositioning technique.

ACTIVE COMPARATOR

Lip repositioning aims to limit the retraction of elevator smile muscles. Lip repositioning results in a shallow vestibuler restricting of the muscle pull; Thereby limiting the gingival display during smiling.(Makkiah, 2017) It is a less invasive, viable substitute for patients, has fewer post-operative complications and provides a faster recovery compared to orthognathic surgery(Grover, Gupta, \& Luthra, 2014).

Drug: Botox Injectable Product

Interventions

Botox Injectable Product DRUG

Botulinum toxin produces partial chemical denervation of the muscle resulting in localized reduction in muscle activity

Also known as: Xeomin

lip repositioning technique with Botox injection.; lip repositioning technique.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gummy smile more than 3mm.
• Adults \>18 years.
• Non-smokers.
• Patients with healthy systemic condition
• Normal clinical crown dimensions.
• Good oral hygiene.

You may not qualify if:

• Natural dentition upper anterior
• Pregnant or lactating women.
• Patients with inflamed gingiva or gingival enlargement.
• Inflammation or infection at the site of injection.
• Patients with allergy to botulinum toxin, lactose, and albumin.
• Concurrent use of aminoglycoside antibiotic that enhances the action of the toxin. (Jaspers, Pijpe, \& Jansma, 2011)
• \< 3 mm attached gingivae that might create difficulties in flap design, stabilization and suturing.
• Patients using anticholinesterase or other agents interfering with neuromuscular transmission

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Gingival Overgrowth

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blinded: Blinding of the participants is not applicable. Blinding of the operator is not applicable. Outcome assessor (primary and secondary outcomes) \& biostatistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Clinical Trial: Parallel group, two arm, non-inferiority trial with 1:1 allocation ratio.

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 24, 2019
• Study Start: September 20, 2019
• Primary Completion: September 20, 2020
• Study Completion: September 20, 2022
• Last Updated: July 24, 2019

Record last verified: 2019-07