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The aim of the proposal study is to answer the question of how to manage gummy smiles due to hypermobile upper lip with less invasive and low risk level procedure . This trial will help the practitioners and the patients in taking the convenient decision to correct the gumminess to restore lip-gingival-dental harmony and enhance smile asthetics.
In this randomized clinical trial , two groups will be included to compare the effectiveness of a treatment modality of botulinum toxin-A injection , in the first group , on gingival display during smiling ,patient satisfaction , lower face esthetics ( upper lip length , upper lip vermillion length , interlabial gap , nasolabial angle) and the postoperative side effects . the comparator group will receive treatment by modified lip repositioning surgery ,to compare the results of the intervention group that can possibly obtained without undergoing surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin A Injection | Experimental | this group will receive Botulinum Toxin A Injection at doses of 2.5 or 5 IU (depending on the degree of gum exposure) on each side of the nasolabial fold with follow up at at 2,4,8,12 and 24 weeks. |
|
| Modified Lip Repositioning Surgery | Experimental | this group will receive Modified Lip Repositioning Surgery with follow up at at 2,4,8,12 and 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin A Injection | Drug | adult patients with gummy smile due to hypermobile upper lip will receive Botulinum Toxin A Injection with a single injection1 cm lateral to the ala horizontally and 3 cm above the lip line vertically. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction and postoperative side effects | it will be assessed using Questionnaire. | at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of gingival display upon smiling | it will be assessed using Digital ruler on DSS software | at 4,8 and 12 weeks |
| Lower face esthatics: a) upper lip length b) upper lip- vermillion length c) interlabial gap |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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single blind
|
| Modified Lip Repositioning Surgery | Procedure | the surgical procedure will be done by removal of strip of epithelium by careful dissection and stabilizing the new mucosal margin to the gingiva to improve the gingival display in adult patients with gummy smile. |
|
it will be assessed using Digital ruler and angle measurement on DSS software
| at 4,8 and 12 weeks |
| Lower face esthatics: d)nasolabial angle | it will be assessed using Digital angle measurement on DSS software | at 4,8 and 12 weeks |
| stability of gummy smile correction. | it will be assessed using Digital ruler on DSS software | at the end of 24 weeks. |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |