| CTRI Number |
CTRI/2024/01/061551 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Botox and Hyaluronic acid filler when given to patients with post Orthodontic treatment to improve the gummy smile |
|
Scientific Title of Study
|
Comparison of effectiveness, duration and patient’s satisfaction of Botulinum toxin A and Hyaluronic filler in the treatment of gummy smile :An in-vivo study |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Truppti P Sonone |
| Designation |
PhD scholar |
| Affiliation |
D.Y.Patil School of Dentistry, Nerul, Navi Mumbai |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,D.Y.Patil School of Dentistry, Nerul, Navi Mumbai , Maharashtra -
Thane
MAHARASHTRA
400706
India |
| Phone |
8909999928 |
| Fax |
|
| Email |
trupptisonone@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Truppti P Sonone |
| Designation |
PhD scholar |
| Affiliation |
D.Y.Patil School of Dentistry, Nerul, Navi Mumbai |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,D.Y.Patil School of Dentistry, Nerul, Navi Mumbai , Maharashtra -
Thane
MAHARASHTRA
400706
India |
| Phone |
8909999928 |
| Fax |
|
| Email |
trupptisonone@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan Patil |
| Designation |
Professor |
| Affiliation |
Yogita Dental College |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Yogita dental college, khed, Ratnagiri, Maharashtra
Ratnagiri
MAHARASHTRA
415708
India |
| Phone |
8909999918 |
| Fax |
|
| Email |
chetanpatil2283@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopaedics, Yogita Dental college , khed, Ratnagiri 415708 |
| Department of Orthodontics and Dentofacial Orthopaedics, D.Y.Patil school of Dentistry,Nerul, Navi Mumbai 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Truppti P Sonone |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics D.Y.Patil School of Dentistry , Nerul, Navi Mumbai |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Truppti P Sonone |
D. Y. Patil Dental College and Hospital,Nerul,Navi mumbai |
Department of Orthodontics and Dentofacial Orthopaedics, 4 the Floor ,room no 401 , sector 5, Nerul
Thane
MAHARASHTRA |
8909999928
trupptisonone@gmail.com |
| Dr Truppti P Sonone |
Yogita Dental College and Hospital, khed |
Department of Orthodontics and Dentofacial Orthopaedics, 2nd floor , room no 26
Ratnagiri
MAHARASHTRA |
8909999928
trupptisonone@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC)for Biomedical and Health Research D.Y.Patil Deemed to be University school of medicine Navi Mumbai, Dept.of Pharmacology, 5th floor, plot no.2 sector 5, Nerul, Navi mumbai |
Approved |
| SHIVTEJ AROGYA SEVA SANSTHAS YOGITA DENTAL COLLEGE & HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 2 - Hyaluronic acid |
Dose : total of 0.9 mL of Hyaluronic acid filler
[Canine Fossa( 0.3ml + 0.3 ml each side)
Anterior Nasal Spine ( 0.3ml of HA) ]
Frequency: once
Route of administration: Deep Supramuscular and/or in a multilayer approach
Total duration of intervention : 90 days
Injection Site :
-Canine Fossa - Inject approximately 0.2 to 0.3 mL per side into the deep layer of the canine fossa (upper part of the nasolabial fold) using a 27-G needle.
- Anterior Nasal Spine - Inject approximately 0.2 to 0.4 mL over the anterior nasal spine at the bony level using a 27-G needle. Method of Injection :The site is prepared by applying a topical anesthetic cream : Lidocaine. The needle to be used is 31 gauge 8 mm. Administration of 23 mg/mL hyaluronic acid using blunt microcannula (25G and 50 mm) in Deep Supramuscular and/or in a multilayer approach..Total amount 0.6 mL of HA per side. Treated area will be the whole white lip, from the entrance to piriformis fossa to the midline. Measurements- Two reference points will be used in the study : A – median point on the lower margin of upper lip; B – midpoint of the line connecting the gingival margins of maxillary central incisors .The gingival display will be measured using a scale and a Vernier calliper for precise measurements between two marked points. The distance between point A which is the tip of the lower margin of the upper lip and point B which is the midpoint of the gingival margin of the central incisor will be measured as the gingival show.
The values will be calculated on 14th day post administration of Hyaluronic acid filler and at the end of 30th , 60th and 90th day. |
| Intervention |
Group A - Botulinum Toxin A |
Dose : total 5 units of BTX -A ( 2.5U per side)
Frequency: once
Route of administration: intramuscular ( IM)
Total duration of intervention : 90 days
DILUTION OF THE BOTOX VIAL: Freeze dried Botulinum Toxin (A) vial 100 units is available in a freeze- dried powder that clumps at the bottom of the vial and is diluted using 4 ml of normal saline. 2.5 units of BTX‑A will be injected under sterile conditions at 4 sites, 2 on each side of the face.
Method of Injection :The needles were inserted at the overlapping points of (i) levator labii superioris alaeque nasi and levator labii superioris muscles; (ii) levator labii superioris and zygomaticus minor muscles on each side of the face. This is roughly about 1 cm lateral and below the nasal ala on each side of the nasal fold. A skin marker will be used to mark the injection points to reduce the risk of asymmetry. The site will be prepared by applying a topical anesthetic cream : Lidocaine. The needle to be used is 31 gauge 8 mm. Injection of 2.5U of Botulinm toxin type-A will be given on both right and left side at YONSEI POINT.
Measurements- Two reference points will be used in the study : A – median point on the lower margin of upper lip; B – midpoint of the line connecting the gingival margins of maxillary central incisors .The gingival display will be measured using a scale and a Vernier calliper for precise measurements between two marked points. The distance between point A which is the tip of the lower margin of the upper lip and point B which is the midpoint of the gingival margin of the central incisor will be measured as the gingival show. The values will be calculated post administration of Botox on 14th day and at the end of 30th , 60th and 90th day. |
| Comparator Agent |
Group A - Botulinum Toxin A and Group B - Hyaluronic acid Filler |
Compare both group A ( Botulinum Toxin A ) and Group B ( Hyaluronic acid filler ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
• Patients with gummy smile more than 3 mm.
• No history of previous treatment for correction of gummy smile.
• Patients wanting aesthetic smile correction without surgery. |
|
| ExclusionCriteria |
| Details |
1.History of neuromuscular disorder
2. Patients allergic to Botolium toxin A and B
3. Patients taking medications that might interfere with the neuromuscular impulse transmission and potentiate the effects of Botolium toxin.
4. Patients who are mentally / physically not stable
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness, duration and patients satisfaction by Botulinum Toxin A and Hyaluronic filler in gummy smile patients |
Each patient will be observed for 3months for the study purpose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness in correction of gummy smile post administration of botox A immediately after 14th day |
1month |
| To assess the effectiveness in correction of gummy smile post administration of Hyaluronic acid Filler immediately after 14th day |
1month |
| To access the stability of duration of gummy smile correction, post-administration of Botox ‑A at the end of 30th , 60th and 90th day. |
1 month |
| To access the stability of duration of gummy smile correction, post-administration of Hyaluronic acid Filler at the end of 30th , 60th and 90th day. |
1 month |
| To assess the gingival display pre and post treatment after administration of Botox -A |
3 months |
| To assess the gingival display pre and post treatment after administration of Hyaluronic acid filler |
3 months |
| To evaluate patients satisfaction in administration of Botox -A |
3 months |
| To evaluate patients satisfaction in administration of Hyaluronic acid filler |
3 months |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Sonone TP, Soni V, Gupta S, Shekatkar YK, Thorat AS, Pol TR. Botox and dermal fillers in orthodontics – A review. J Pharm Bioall Sci 2022;14:S60-4. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised, double- blinded,before and after study, a prospective study,an experimental comparative, clinical study. The study is to compare Botox -A and Hyaluronic acid filler when given as an adjunct to orthodontic treatment to improve the smile esthetics. Primary outcome is to compare the effectiveness of Botulinum toxin A and Hyaluronic filler in the treatment of gummy smile. Secondary outcomes are to assess immediate effectiveness of botox-A and Hyaluronic acid filler on 14th day , to assess the stability of gummy smile correction post administration of Botox-A and Hyaluronic acid Filler on 30th , 60 the , and 90th day , to evaluate patients satisfaction post administration of Botox-A and Hyaluronic acid Filler and to assess the gingival display pre and post administration of Botox-A and Hyaluronic acid filler |