DISSERTATION – SYNOPSIS
Dr. JIBIN SKARIA
POST GRADUATE STUDENT
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS
A .J. INSTITUTE OF DENTAL SCIENCES, MANGALORE
2013 – 2016
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATEAND ADDRESS
(IN BLOCK LETTERS) / DR. JIBIN SKARIA.
POST GRADUATE STUDENT,
DEPT. OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS
A. J. INSTITUTE OF DENTAL SCIENCES MANGALORE, KARNATAKA.
2 / NAME OF THE INSTITUTION / A. J. INSTITUTE OF DENTAL SCIENCES
MANGALORE, KARNATAKA.
3 / COURSE OF STUDY AND SUBJECT / MASTER OF DENTAL SURGERY
ORTHODONTICS AND DENTO FACIAL
ORTHOPEDICS.
4 / DATE OF ADMISSION OF COURSE / 5TH JULY 2013
5 / TITLE OF THE TOPIC: / “BOTULINUM TOXIN TYPE A (BOTOX) AS A SUPPLEMENTARY METHOD FOR THE NEUROMUSCULAR CORRECTION OF EXCESSIVE GINGIVAL DISPLAY ON SMILING”
6 / BRIEF RESUME OF THE INTENDED WORK:
6.1. NEED FOR THE STUDY:
Gummy smile is a very unaesthetic and common condition defined as the exposure, while an individual is smiling, of more than 3 mm of gingival tissue. This is attributable to several factors including, hyper function of the peri oral muscles, lip length, clinical crown length, and skeletal problems caused by maxillary excess and delayed passive eruption resulting in gingival problems. Many authors have proposed surgical approaches1, 2, 3 but these procedures are associated with morbidity and high cost and are time consuming.
The purpose of this study is to assess the effect of BOTULINUM TOXIN TYPE –A in
patients with hyper functional upper lip elevator muscles and to establish an effective
method for correction of gummy smile.
7. / 6.2 REVIEW OF LITERATURE:
1. POLO M. (2005)4 conducted a study in which five subjects with excessive gingival display due to hyper functional lip elevator muscles. Under sterile conditions 1.25 Units of Botox was injected in right and left levator labii superioris and levator labii superioris alaeque nasi. Then an additional 1.25 units per side were injected at the overlap areas of levator labii superioris and zygomatic minor muscles. Patients were evaluated after 1, 2, 4, 16 weeks. Changes were documented in photographs; treatment modality was effective in producing aesthetically acceptable smiles in patients.
2. SANDLAR P: ALYSAYER F: DAVIS S.F (2007)5 reported a patient complaining of gummy smile with Botox to reduce hyper mobility of her upper lip. Three months after treatment patient was delighted with the results obtained. The results were completely reversed in six months after initial treatment procedure and patient had reverted back to the original situation.
3. POLO M. (2008)6 conducted a study in which thirty five patients received Botox injections to reduce gingival display. Injection sites were determined by muscle animation (smiling) and palpation to ensure precise muscle location before injection. Under sterile conditions 2.5 units of Botox were injected in both overlapping points of levator labii superioris, leavtor labii alaequae nasi and leavotor labii superioris, zygomaticus minor muscle sites. Patients were followed at 2, 4, 8, 12, 16, 20, 24 weeks post injection. After 24 weeks mean gingival reduction was 5.2mm.
4.HWANG W:HUR M:SEOK H: KI-SEOK K:BAIK H(2009)7 studied 50 hemi faces from 25 adult cadavers to establish topographic relations and directions of muscles including lip elevator, leavtor labii superioris, leavtor labii superioris alaeque nasi and zygomaticus minor. The mean angle between the facial midline and each muscle vector was 25.8 ±4.8 degrees for the leavtor labii superioris, 55.7±6.4 degrees for zygomatic minor and -20± 3.2 degrees for the leavtor labii superioris alaeque nasi. The three vectors passed near a triangular formed by three surface land marks. The center of this triangle named “YONSEI POINT” suggested as an appropriate site for Botox injections. The author also reported two cases, in which injections of 3 units of Botox at each yonsei point caused the gingival display to reduce 2 mm after a week.
5. Malay waghamshi(2009)8 reported two cases treated for excessive gingival display with
Botox. Case 1 had no lip incompetency and 5 mm gingival display at rest. Case 2
showed anterior protrusion, spacing, and excessive gingival display and mentalis
hyper activity. Under sterile conditions a dose of 1.25units of Botox was injected to both
right and left leavtor labii superioris and leavtor labii superioris alaeque nasi, and
additional 1.25 units per side at the overlapping areas of the leavtor labii superioris
and zygomaticus minor.
OBJECTIVES OF THE STUDY:
1. To assess the effect of Botulinum toxin-type A on gingival display at the interval of 2 weeks, 4 weeks, 12 weeks, and 24 weeks post injection.
2. To establish effectiveness in correction of gummy smile to provide consistent, esthetically pleasing results.
7.1 MATERIALS AND METHODS:
SOURCE OF DATA:
This study will be done on patients who report to department of Orthodontics and
Dentofacial Orthopedics of A J INSTITUTE OF DENTAL SCIENCES MANGALORE.
METHOD OF COLLECTION OF DATA
20 Patients with a minimum age is 18 years will be selected.
INCLUSION CRITERIA
3 mm or more of gingival display on smiling.
EXCLUSION CRITERIA:
1. Excessive hypertrophic gingiva.
2. Subjects allergic to Botulinum toxin - A or albumin injections or history of previous
injections of Botulinum toxin - A to the head & neck.
3 Persons with amytrophic sclerosis, motor neuropathy, myasthenia gravis.
4. Pregnant & breast feeding females.
5. Subjects participating in another drug or study.
6. Patient using certain medications such as ,
amino glycosides, anticholinesterases, other agents interfering with the
neuromuscular transmission.
7.2 ABOUT BOTOX
100 U of vacuum-dried Botulinum type A used (BOTOX) will be used.
METHOD OF PREPARATION:
Botulinum type A will be 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 which will result in a 2.5
Units/0.1mL dose.
7.3 METHOD:
Patient’s medical history will be reviewed before conducting the study. Written consent
will be taken from patient. Nikon d 3200 camera will be used for taking close up peri oral
photographs and full face front smiling photographs. Efforts will be taken to obtain
standardized, non posed, spontaneous smile.
Periodontal evaluation will be performed to rule out delayed passive eruption leading to
excessive gingival display. To measure the amount of 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 are taken.
7.4 INJECTION METHOD:
Initially 0.20 Units of Botulinum toxin type A will be injected intradermally in forearm for
allergy test. Patient will be observed for 30 minutes for any allergic reaction.
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, and an additional 1.25 U
per side at the overlap areas of the levator labii superioris and zygomaticus minor muscles.
Aspiration before Botox 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, 12weeks, 24 weeks.
7.5. DOES THE STUDY REQUIRE ANY INVESTIGATIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS, ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY?
Yes, injection of botulinum toxin type A in to levator labii muscles.
7.6. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.5?
Yes.
7.7 INVESTIGATION DESIGN
LIST OF REFERENCES:
1. Frank J, Peter H. Orthognathic surgery effects on maxillary growth in patients withvertical maxillary excess. Am J Orthod Dentofacial Orthop 1997;111:288-96
2. Tresa Pinho Adriano F. Orthodontic –orthognathic surgical treatment in a patient
with class 2 malocclussion. Am J Orthod Dentofacial Orthop 2011;140:703-12
3. Rui shu, Lan huang Adult class 2 patient with severe gummy smile treated with
temporary anchorage devices . Am J Orthod Dentofacial Orthop 2011;140:97-105
4. Polo m.”Botulinum toxin type a in the treatment of excessive gingival display”
American journal of orthodontics and dentofacial orthopedics, 2005:127:214-8.
5. PJ Sandlar, F Alysayer, SJ Davies. Botox: “A possible new treatment for gummy smile”. Virtual journal of orthodontics, 2007; 30 – 34.
6. Polo m. “Botulinum toxin type A (Botox) for neuromuscular correction of excessive gingival display on smiling”. Journal of orthodontics and dentofacial orthopedics, 2008; 133:195-203.
7. 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.
8. 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 / DR. GAUTHAM HEGDE, MDS
READER, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS.
A. J. INSTITUTE OF DENTAL SCIENCES
MANGALORE, KARNATAKA.
11.2 SIGNATURE OF GUIDE
11.3. CO-GUIDE (If any) / PROF. DR. ROHAN RAI, MDS
PROFESSOR & HEAD, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS.
A.J. INSTITUTE OF DENTAL SCIENCES
MANGALORE, KARNATAKA.
11.4. SIGNATURE
11.5.
HEAD OF THE DEPARTMENT / PROF. DR. ROHAN RAI, MDS
PROFESSOR & HEAD, DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS.
A.J. INSTITUTE OF DENTAL SCIENCES
MANGALORE, KARNATAKA.
11.6. SIGNATURE
12 / 12.1. REMARKS OF THE CHAIRMAN & PRINCIPAL PROF.DR. DEEPAK NAYAK U. S
12.2. SIGNATURE
CONSENT FORM
1) INFORMATION SHEET
TITLE OF RESEARCH:
“BOTULINIM TOXIN TYPE A (BOTOX) AS A SUPPLEMENTARY METHOD FOR THE NEUROMUSCULAR CORRECTION OF EXCESSIVE GINGIVAL DISPLAY ON SMILING”
INVESTIGATORS:
Dr.GAUTHAM HEGDE,
Reader,
Department of Orthodontics and Dentofacial Orthopedics,
A. J. Institute of Dental Sciences, Mangalore - 04
Dr. JIBIN SKARIA,
1st year Post graduate,
Department of Orthodontics and Dentofacial Orthopedics,
A. J. Institute of Dental Sciences, Mangalore - 04
.
INTRODUCTION:
I Dr Jibin skaria, Post Graduate Student in the Department of Orthodontics and Dentofacial Orthopedics A. J. Institute of Dental Sciences Kuntikana Mangalore is working on my dissertation titled “ BOTULINUM TOXIN TYPE A(BOTOX) AS A SUPPLEMENTARY METHOD FOR THE NEUROMUSCULAR CORRECTION OF EXCESSIVE GINGIVAL DISPLAY ON SMILING ”
My study subject will be 20 patients above 18 years having gummy smile referred to Department of Orthodontics, A. J. Institute of Dental Sciences Mangalore.
VOLUNTARY PARTICIPATION
Your participation in this research is entirely voluntary. It is your choice whether to participate or not.
EXPLANATION OF THE PROCEDURE:
To assess the effect of Botulinum toxin -type A on gingival display at the interval of 2weeks, 4 weeks, 12 weeks, and 24 weeks post injection. These injections have been used for more than a decade in children and adults to improve the problem of muscle spasm of the facial muscles. Improvement in injected areas in the muscles around lips will occur within two weeks. The solution is injected with a small needle into the muscle. You will see benefits
develop within the next 10-14 days. Typically muscle action will return within 3-5 months
POSSIBLE BENEFITS:
1. correction of gummy smile
2. psychological benefit to patient
3. minimally invasive
.
POSSIBLE RISKS:
1. Local bleeding
2. Bruising
3. Under correction (not enough effect) or overcorrection (too much effect)
4. Facial asymmetry (one side looks different than the other)
5. Paralysis of a nearby muscle leading to difficulty in whistling or drinking from a straw
6. Generalized weakness
7. Permanent loss of muscle tone with repeated injection
8. Flu-like syndrome
9. Development of antibodies to BOTOX®
10. Infection
CONFIDENTIALITY:
The information that we collect from this research project will be kept confidential. Information about the patient that will be collected during the research will be put away and no-one but the researchers will be able to see it. Any information about the patient will have a number code and the name & identity of the patient will be kept confidential.
WITHDRAWAL:
You are entitled to withdraw from the study at any point of time.
SIGNIFICANT NEW FINDINGS:
New findings as and when made regarding your condition would be informed to you.
PAYMENT IN CASE OF UNTOWARD INCIDENTS DURING THE STUDY:
No monetary compensation would be given in case of untoward incidents such as occurrence of complications during the study.
CONTACTS:
If you have any questions about your investigation and study, you may please contact.
Dr. GAUTHAM HEGDE,
READER,
Department of Orthodontics and Dentofacial Orthopedics,
A. J. Institute of Dental Sciences, Mangalore - 04
OR
Dr. JIBIN SKARIA,
1st year Post graduate,
Department of Orthodontics and Dentofacial Orthopedics,
A. J. Institute of Dental Sciences, Mangalore – 04
Mobile No. - 9972988949
LEGAL RIGHTS:
By signing on the consent form you will be waiving off all legal liabilities against the institution and staff.
CERTIFICATE OF CONSENT
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research.
Print Name of Participant______
Signature of Participant ______
Date ______
Day/month/year
If illiterate
A literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team). Participants who are illiterate should include their thumb-print as well.