Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577285
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
The Effect Of Botox In Patients With Gummy Smile With And Without Zinc And Phytase Supplementation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect Of Botulinum Toxin A In Patients With Excessive Gingival Display With And Without Zinc And Phytase Supplementation A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Participants with esthetic concern of excessive gingival display who meets the inclusion criteria will be carried out including history taking clinical examination and initial therapy
The initial therapy will consist of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study
Patients in the intervention group I will take zinc gluconate 50 mg 1 per day to increase zinc level with phytase supplement 176mg 800FTU 2 tablets per day to give the maximum absorption of zinc both supplements will be given for 4 days before botulinum toxin injections Patients in the intervention group II will take zinc gluconate 50 mg 1 per day to increase zinc level 4 days before botulinum toxin injections
Patients in the control group will receive the Botulinum toxin injections only Clinical photographs will be taken at baseline 2 weeks 1 month 3 months postoperatively
The initial therapy will consist of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study
Patients in the intervention group I will take zinc gluconate 50 mg 1 per day to increase zinc level with phytase supplement 176mg 800FTU 2 tablets per day to give the maximum absorption of zinc both supplements will be given for 4 days before botulinum toxin injections Patients in the intervention group II will take zinc gluconate 50 mg 1 per day to increase zinc level 4 days before botulinum toxin injections
Patients in the control group will receive the Botulinum toxin injections only Clinical photographs will be taken at baseline 2 weeks 1 month 3 months postoperatively
Detailed Description:
Initial examination
Participants with esthetic concern of excessive gingival display who meets the inclusion criteria will be carried out including history taking clinical examination and initial therapy
The initial therapy will consist of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques
Preoperative procedures
Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study
Clinical photographs
Clinical photographs will be taken at baseline 2 weeks 1 month 3 months postoperatively
Intervention group I
Patients in the intervention group I will take zinc gluconate 50 mg Now food company 1 per day to increase zinc level with phytase supplement 176mg 800FTU Goodphyte company 2 tablets per day to give the maximum absorption of zinc both supplements will be given for 4 days before botulinum toxin injections
Intervention group II
Patients in the intervention group II will take zinc gluconate 50 mg Now food company 1 per day to increase zinc level 4 days before botulinum toxin injections
Control group
Patients in the control group will receive the Botulinum toxin injections only
Botulinum toxin type A injection
The patients will be injected at both sides into the Yonsei point 3Units the point that would target 3 muscles responsible for upper lip elevation during smiling including the levator labii superioris alaeque nasi LLSAN in a single injection This landmark will be identified as the center of a triangle formed by the convergence of the LLSAN the levator labii superioris LLS and the Zygomaticus minor muscles and is located 1 cm lateral to the ala horizontally and 3 cm above the lip line vertically in both men and women Hwang et al 2009 and Nasr et al 2015
Postoperative care
After Botox injection the patients will be instructed to
1 Remain upright for 4 hours after injection patients may lie in a reclined position but not lay flat
2 Refrain from aerobic exercise that increases the heart rate
3 Not to massage or manipulate injected areas for 24 hours after injections
4 Refrain from using ibuprofen for 24 hours following injection
5 If bruising appears apply ice to area for 15 minutes every hour to decrease bruising
Follow up
Botox will gradually take effect over 7-10 days with optimum result at 2 weeks After 2 weeks the patients would come for an additional touch up dose 1 unit at each injection point
Participants with esthetic concern of excessive gingival display who meets the inclusion criteria will be carried out including history taking clinical examination and initial therapy
The initial therapy will consist of periodontal treatment phase I therapy including supragingival scaling subgingival debridement if needed The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques
Preoperative procedures
Patients who have inadequate crown length and width ratio or short clinical crown will receive esthetic crown lengthening procedure to adjust gingival levels before being included in this study
Clinical photographs
Clinical photographs will be taken at baseline 2 weeks 1 month 3 months postoperatively
Intervention group I
Patients in the intervention group I will take zinc gluconate 50 mg Now food company 1 per day to increase zinc level with phytase supplement 176mg 800FTU Goodphyte company 2 tablets per day to give the maximum absorption of zinc both supplements will be given for 4 days before botulinum toxin injections
Intervention group II
Patients in the intervention group II will take zinc gluconate 50 mg Now food company 1 per day to increase zinc level 4 days before botulinum toxin injections
Control group
Patients in the control group will receive the Botulinum toxin injections only
Botulinum toxin type A injection
The patients will be injected at both sides into the Yonsei point 3Units the point that would target 3 muscles responsible for upper lip elevation during smiling including the levator labii superioris alaeque nasi LLSAN in a single injection This landmark will be identified as the center of a triangle formed by the convergence of the LLSAN the levator labii superioris LLS and the Zygomaticus minor muscles and is located 1 cm lateral to the ala horizontally and 3 cm above the lip line vertically in both men and women Hwang et al 2009 and Nasr et al 2015
Postoperative care
After Botox injection the patients will be instructed to
1 Remain upright for 4 hours after injection patients may lie in a reclined position but not lay flat
2 Refrain from aerobic exercise that increases the heart rate
3 Not to massage or manipulate injected areas for 24 hours after injections
4 Refrain from using ibuprofen for 24 hours following injection
5 If bruising appears apply ice to area for 15 minutes every hour to decrease bruising
Follow up
Botox will gradually take effect over 7-10 days with optimum result at 2 weeks After 2 weeks the patients would come for an additional touch up dose 1 unit at each injection point
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None