Dept. Of orthodontics and dentofacial orthopedics rajrajeshwari dental college and hospital, mysore road, bangalore-74



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE II



PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1

NAME OF THE CANDIDATE

AND ADDRESS

(IN BLOCK LETTERS)

DR. N.SUBHALAKSHMI.

POST GRADUATE STUDENT,

DEPT. OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS RAJRAJESHWARI DENTAL COLLEGE AND

HOSPITAL, MYSORE ROAD, BANGALORE-74.



2

NAME OF THE INSTITUTION

RAJARAJESHWARI DENTAL COLLEGE AND HOSPITAL,

BANGALORE ( KARNATAKA).




3

COURSE OF STUDY AND SUBJECT

MASTER OF DENTAL SURGERY

ORTHODONTICS AND DENTO FACIAL

ORTHOPEDICS.



4

DATE OF ADMISSION OF COURSE

19.4.2010

5

TITLE OF THE TOPIC:
“BOTULINUM TOXIN TYPE A (BOTOX) FOR NEUROMUSCULAR CORRECTION OF EXCESSIVE GINGIVAL DISPLAY ON SMILING (GUMMY SMILE)




6


BRIEF RESUME OF THE INTENDED WORK:

6.1. NEED FOR THE STUDY:


  • A non surgical method of correction of gummy smiles when compared to surgical intervention is readily accepted by patients. Hence this study will be undertaken to assess the effect of Botulinum toxin type – A on the upper lip stretch and gummy smiles. The result can be of clinical significance in accepting, Botulinum toxin type – A injection as a alternative to maxillary surgery in selected cases.

.







REVIEW OF LITERATURE:

  1. In this study, 5 subjects with excessive gingival display due to hyper functional upper lip elevator muscles were treated with BTX – A injections. Reference points are established .Under sterile conditions 1.25U per side was injected in both the right & left levator labii superioris & left levator labii superioris alaeque nasi muscle(LLS) & an additional 1.25U per side at the overlap areas of the left levator labii superioris & zygomaticus minor muscles,& at the origin of depressor septi muscles at the orbicularis muscle .patient is evaluated 1,2,4,16 weeks postoperatively, changes are documented in photographs.1




  1. In this study the author has taken a case showing 7 – 8 mm of gingival

display ,with competent lips & normal lip line .The 160U botox powder was mixed

with 4ml of saline & was therefore provided at 40U/ml. The botox was injected in

small increments.2
3. The aim of this study was to reduce the gingival display of 3mm using botox .

In this study, thirty five patients received BTX injections to reduce the gingival display. patients Injection sites were determined by muscle animation(smiling) & palpation to ensure precise muscle location before injection .Under sterile conditions 2.5 units were injected in both overlapping points of right& left levator labii superioris & levator labii superioris alaeque nasi & zyomaticus minor muscle sites. Patients were followed at 2, 4,8,12,16,20,24 weeks post injection, changes are documented in photographs. A satisfaction scale is used 1 to 5 point scale is used(5-excellent,4-verygood,3.good,2.fair,1.poor).Gingival display gradually increased 2


weeks post-injection. After 24 weeks, the mean gingival reduction was 5.2mm.3


  1. In this study, the authors have taken 50 hemi faces from 25 adult cadavers to

establish topographic relations & direction of lip elevator muscles, levator labii


superioris & llevator labii superioris alaeque nasi,& zygomaticus minor, The mean
angle between the facial midline and each muscle vector was 25.8 + or - 4.8 degrees
for the LLS, 55.7 + or - 6.4 degrees for the ZMI, and - 20.2 + or - 3.2 degrees for the
LLSAN; The three vectors passed near a triangular region formed by three surface
Landmarks. The center of this triangle ,named the ‘‘Yonsei point’’, was suggested
as an appropriate injection point for BTX-A. In this study authors have taken two
cases ,one with 5mm gingival display 3.0U at each yonsei point, gingival display
was reduced to 2mm after a week, 19 months of orthodontic treatment, the patient’s
smile was still asymmetric because of the uneven lip line with unilateral gingival
Display of 4 mm above the left canine, BTX was unilaterally injected. After1 week,
gingival exposure was eliminated and symmetric elevation of the upper lip was
Clinically observed.4



  1. In this study , author has taken two cases

case1: No lip In competency & 5mm gingival display at rest.


case 2: Anterior protrusion, spacing, & excessive gingival display & mentalis
hyperactivity. Under sterile conditions a dose of 1.25 U per side was injected in both
right and left levator labii superioris & llevator labii superioris alaeque nasi & an
additional 1.25 units per side at the overlap areas of the levator labii superioris &
zygomaticus minor. Gingival display was reduced to1.5mm after 1 week in case1,
gingival display was reduced to 2mm after 1 week in case2. Following aspiration
into the upper circumoral musculature with aim of effecting levatorlabii superioris &
the zygomaticus muscle areas,to reduce lip hypermobility.after three weeks gingival
exposure to ideal level.5

6.3

OBJECTIVES OF THE STUDY:


  1. To assess the effect of Botulinum toxin – type A on gingival display at smile.

  2. To assess the effect of Botulinum toxin – type A on gingival display at the interval of 2weeks,4 weeks,8 weeks,16 weeks,24 weeks.



7

MATERIALS AND METHODS:


    1. SOURCE OF DATA:

This study will be done on patients who report to department of Orthodontics and

Dentofacial Orthopedics, RajaRajeshwari Dental College and Hospital, Mysore Road, Bangalore.


    1. METHOD OF COLLECTION OF DATA

10 Patients will be selected of both the sexes between age group of 16 - 27 years.



INCLUSION CRITERIA

    • 5mm or more of gingival display on smiling.

EXCLUSION CRITERIA:

1. Vertical maxillary excess.

2. Excessive hypertrophic gingiva.

3. Subjects allergic to Botulinum toxin - A or albumin injections or history of

previous injections Botulinum toxin - A to the head & neck .

4 Persons with amytrophic sclerosis, motor neuropathy, myasthenia gravis.

5. Pregnant & breast feeding females.

6. Subjects participating in another drug or study.

7.patient using certain medications such as ,

aminoglycosides , anticholinesterases,other agents interfering with the

Neuromuscular transmission.


  • Informed consent will be taken from the patient, parents or guardians.

  • Patients medical history is reviewed before conducting the study.

  • Lateral Cephalogram is taken & analysed to rule out vertical maxillary excess.

  • Pre-treatment photographs are taken.


MATERIALS & METHODS:
ABOUT BOTOX
100 U of vacuum – dried botulinum type A used (botox or dysport) is used.
METHOD OF PREPARATION:
Botulinum type A was diluted by adding 4.0 mL of 0.9% normal saline solution
without preservatives to 100 U of vacuum-dried C botulinum type - A neurotoxin

Complex, according to the manufacturer’s dilution technique. This resulted in a 2.5


U/0.1mL dose.
METHOD:
Cephalometric analysis will performed to determine whether the gummy smile is
Skeletal due to vertical maxillary excess. Periodontal evaluation will be performed
to rule out delayed passive eruption leading to excessive gingival display.
Extra – oral photographs will be taken , including a close – up photograph with
ruler placed vertically at the facial midline while the patient is smiling .The spot
where the superior portion of the ruler barely touched the midline of the columella‘s
most inferior portion at the nasolabial junction will be designated as reference
point1 (RP1).

The ruler passed through the middle of the philtrum and extended inferiorly


into the midline of the chin .The incisal edge of the maxillary right central incisor
Along its mesial surface at the midline will be designated reference point 2 (RP2).
The distance between the reference points will be constant for each subject when the
full smile photographs is taken; minor variations (1.0mm or less) between RP1
and RP2 measurements taken before and after the procedure would be compensated
For when they will be recorded.
INJECTION METHOD:

After carefully reviewing the literature for small muscle dosage, a dose of 1.25 U per


muscle site per side is selected as a baseline to start the study .Under sterile
conditions, 1.25 U per side will be injected in both the right and left levator labii
superioris and levator labii superioris alaeque nasi muscles (LLS), and an additional
1.25 U per side at the overlap areas of the levator labii superioris and zygomaticus
Minor muscles (LLS/ZM). Aspiration before BTX-A injection will be done to avoid
Involuntary deposition of the toxin into the facial arteries.
The effect of botox on gingival display will be measured at the interval of
2weeks,4 weeks,8weeks,16 weeks,24 weeks.







METHOD OF STATISTICAL ANALYSIS:
The Statistical significance will be calculated using paired t- test.
7.3. DOES THE STUDY REQUIRE ANY INVESTIGATIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS, ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY?

YES.


Lateral cephalogram

Pre -treatment & follow up extra – oral photographs at regular intervals at rest &

smiling will be taken.





7.4. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?

YES.




LIST OF REFERENCES :





  1. Polo m.”Botulinum toxin type a in the treatment of excessive gingival display”

American journal of orthodontics and dentofacial orthopedics, 2005:127:214-8.




  1. PJ Sandlar, F Alysayer, SJ Davies. Botox : “A possible new treatment for gummy smile”. Virtual journal of orthodontics, 2007; 30 – 34.

  2. Polo m. “Botulinum toxintype A (Botox) for neuromuscular correction of excessive gingival display on smiling”. Journal of orthodontics and dentofacial orthopedics , 2008;133:195-203.

  3. Woo-Sang Hwang : Mi-Sun Hur: Kyung Seok Hu: Wu Chul Song : Ki-Seok Koh: Hyoung-Seon Baik: Seong-Taek Kim: Kee-Joon Lee : “Surface Anatomy of the Lip Elevator Muscles for the treatment of Gummy Smile Using Botolinum Toxin”: Angle Orthodontics, 2009;79:70-77.

  4. Malay waghamshi.”Botox” – A tool for the treatment of gummy smiles & enhancing facial esthetics: journal of the Indian academy of aesthetic & cosmetic dentistry, 2009s; 5 -12.



9

SIGNATURE OF THE CANDIDATE



10

REMARKS OF THE GUIDE





11



11.1.

NAME & DESIGNATION OF

(in block letters)

GUIDE

Prof. Dr. RAJKUMAR .S.ALLE., M.D.S.D.N.B PROFESSOR & HEAD, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS.

RAJRAJESHWARI DENTAL COLLEGE AND HOSPITAL, MYSORE ROAD, BANGALORE-74.




11.2 SIGNATURE OF GUIDE







11.3. CO-GUIDE (If any)







11.4. SIGNATURE




11.5.

HEAD OF THE DEPARTMENT


Prof. Dr. RAJKUMAR .S.ALLE, M.D.S. PROFESSOR & HEAD, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS.

RAJRAJESHWARI DENTAL COLLEGE AND HOSPITAL, MYSORE ROAD, BANGALORE-74.




11.6. SIGNATURE




12



12.1. REMARKS OF THE CHAIRMAN & PRINCIPAL







12.2. SIGNATURE




Directory: cdc -> onlinecdc -> uploads
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