Evaluating Lip Repositioning for the Treatment of Excess Gingival Display With and Without Pretre… (NCT04030767) | Clinical Trial Compass
UnknownPhase 1
Evaluating Lip Repositioning for the Treatment of Excess Gingival Display With and Without Pretreatment With Botox
22 participantsStarted 2019-09-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Gummy smile more than 3mm.
✓. Adults \>18 years.
✓. Non-smokers.
✓. Patients with healthy systemic condition
✓. Normal clinical crown dimensions.
✓. Good oral hygiene.
Exclusion criteria
✕. 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)
What they're measuring
1
change in amount of gingival display
Timeframe: recorded at baseline, 3, 6 ,9 months and 1 year