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Rajiv Gandhi University of Health Sciences, Bangalore,
Karnataka.
MDS ORTHODONTICS & DENTOFACIAL ORTHOPEDICS
Synopsis for Registration of Dissertation.
M. R. Ambedkar Dental College and Hospital
#1/36, Cline Road, Cooke Town,
Bangalore, Karnataka- 560005.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE.
ANNEXURE II
SYNOPSIS FOR REGISTRATION OF DISSERTATION
1
1
1
Dr. AKHILESH. SM
NAME OF THE CANDIDATE AND
ADDRESS
1.
M. R. Ambedkar Dental College &
2
2.
3
3.
Dept. Of Orthodontics
M. R. Ambedkar Dental College &
Hospital
#1/36, Cline Road ,Cooke Town
Bangalore-560005.
NAME OF INSTITUTION
Hospital
#1/36, Cline Road ,Cooke Town
Bangalore-560005.
COURSE OF STUDY AND
SUBJECT
M.D.S ORTHODONTICS
DATE OF ADMISSION
04 /07/2011
4
4.
5
TITLE OF THE TOPIC:
5.
“ION RELEASE FROM ORTHODONTIC BRACKETS IN THREE
FLUORIDATED MOUTHWASHES”- AN IN VITRO STUDY.
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
During the last decade, there has been increased interest among dental and biomedical
professionals in the side effects associated with the use of biomaterials, especially the
metallic materials.
Fixed appliances in orthodontics involve brackets and arch wires that are metallic. These
brackets are exposed to the oral cavity, which is a potentially hostile environment where
electrochemical corrosion can occur.
The corrosion of orthodontic appliances in the oral environment has concerned clinicians
for sometime; this concern is focused around two principal issues; whether corrosion
products , if produced, are absorbed into the body and cause either localized or systemic
effects; and what the effects of corrosion are on the physical properties and the clinical
performance of orthodontic appliances.
Corrosion occurs from either loss of metal ions directly into the solution or progressive
dissolution of a surface film, usually an oxide or sulphide. Essentially, corrosion occurs
from two simultaneous reactions: oxidation and reduction (redox).
The regular use of fluoride – containing products such as toothpaste and fluoride
mouthwashes is recommended to reduce the risk of dental caries. However, numerous
studies have shown that in an acidic environment and in presence of fluoride ions, the
corrosion resistance of certain materials can deteriorate.
Generally stainless steel alloys that contain 8% to 12% nickel and 17% to 22 % chromium
are used for the metallic part of orthodontic appliances. Corrosion of stainless steel
brackets causes many metal ions to leach out of the metallic part of the orthodontic
appliance, nickel ion being one of them.
The harmful effect of nickel is that it is carcinogenic, causes allergic reactions like
contact dermatitis, and also causes mutation which has been systematically investigated at
the cell, tissue, organ and at organism level.1
Recently, a new mouthwash, Amflor (Group Pharma) containing amine fluoride has been
introduced in the market. Since there are no studies investigating the effect of this
mouthwash on orthodontics brackets, this study will be carried out to investigate the same.
6.2 REVIEW OF LITERATURE:
Ion release from stainless steel orthodontic brackets using 3 different mouthwashes using
inductively coupled plasma spectrometer was studied and results showed that ion released
in deionised water (control) was significantly higher than in the 3 mouthwashes. The
highest ion release in the mouthwashes was found with chlorhexidine compound, while the
other two mouthwashes showed no significant nickel, chromium, copper, iron ion release
in oral B and Persia mouthwash. The level of manganese release was significantly different
in the 4 groups. 2
A study was conducted on metal ion release from new and recycled stainless steel brackets.
The base of the steel brackets was coated with adhesive and brackets were heat treated
before being tested. The release of nickel, copper, iron, chromium,and manganese ions
were analyzed by Atomic absorption spectrometer (AAS). The results showed that recycled
brackets released more ions than new brackets. Brackets immersed in solution of pH 4
released more ions than those immersed in solution pH 7 and total amount of ion release
increased with time over a 48 week period.3
A study was conducted to compare in vitro the corrosion rate of a standard orthodontic
appliance. In this study brackets and bands (AISI 305 and 316) and bonded brackets (AISI
303 and 304) were immersed in artificial saliva medium at 37°C and evaluated at
1,7,14,21,and 28 days, It was concluded that orthodontic
appliances release measurable amounts of nickel and chromium when placed in artificial
saliva medium. For both arch wire types the release of nickel averaged 37 times greater
than that for chromium. 4
The amount of nickel and chromium released from simulated appliance using 0.05%
sodium chloride solution was evaluated. It was concluded that release of nickel is 40 micro
grams and chromium 36 micro grams per day. 5
The short term clinical effects of 0.12% chlorhexidine gluconate and placebo mouth rinses
in 30 adolescents (age 11 to 15) undergoing orthodontic treatment was compared. Subjects
were randomized into experimental (CHX) and control (C) groups. Baseline values were
recorded 10 days after prophylaxis and included plaque index (PI), gingival index (GI),
rentention index (RI), discoloration index (DI) and probing depth (PD). Both groups (CHX
AND C) received soft toothbrushes with instructions to brush twice daily, as well as CHX
and placebo mouthrinses respectively, with oral and written instructions for rinsing twice
daily with 15 mL for 30 seconds. Re-evaluations were performed one, two, and three
months after baseline, except for DI and PD which were only assessed at 3 months. The
data indicated that the use of CHX, in addition to regular oral hygiene habits, was effective
in reducing plaque and gingivitis in adolescents undergoing orthodontic treatment.6
6.3 OBJECTIVES OF THE STUDY:
1. To measure the amount of metal ions released from stainless steel orthodontic brackets
incubated in de-ionised water.
2. To measure the amount of metal ions released from the stainless steel orthodontic
brackets incubated in three different fluoridated mouthwashes.
3. To compare the amount of metal ions released in these mouthwashes with that released
in de-ionised water.
7. MATERIALS AND METHODS:
7.1 Sources of data:
1. Eighty stainless steel brackets (0.022-in, 3M Unitek, Monrovia, Calif)
2. De-ionised water
3. Three fluoridated mouthwashes
A. Colgate Plax
B. Amflor
C. Phos-flur
4. Atomic absorption spectrometer (Avanta AAS)
5. pH meter (Eutech company)
6. Incubator
7.2 Methodology:
Eighty (3M Unitek) stainless steel brackets will be divided in four equal groups of
twenty each, termed “Group 1”, “Group 2”, “Group 3”, “Group 4”.
Group 1 will be considered as the “control” and will be immersed into de-ionised water.
Group 2, 3 and 4 will be subsequently immersed into 3 fluoridated mouthwashes with
differing concentrations of fluoride: Colgate Plax, Amflor and Phos-flur respectively.
The pH of each mouthwash will be noted using pH meter.
Each bracket of the control group will be placed in 20 mL plastic vial containing 15 mL of
de-ionised water. Each bracket of the study groups will be placed in 20 mL plastic vial
containing 15 mL of the respective mouthwash.
All the samples (brackets) will be incubated in an incubator in which the temperature is
maintained at 37 degrees centigrade for 52 days. Immersing the samples for 52 days is
equal to 75,000 minutes, which is equivalent to rinsing the mouth with a fluoridated
mouthwash twice a week for 1 minute for 2 years. This is based on the assumption that
after rinsing, the effect of the mouth wash is present for at least six hours2. 6 hours x twice
a week x 104 weeks = 360 x 2 x 104 = 74,880 (this was rounded off to 75,000 minutes).
After incubation for 52 days, the samples containing stainless steel brackets will be
subjected to atomic absorption spectrometer.
Before subjecting the sample solution to AAS it will be centrifuged at 3000 rpm and then
the sample solution will be allowed to settle
Once settling takes place the sample will be subjected to AAS for scientific reading.
7.3 ANALYSIS OF DATA:
One way analysis of variance (ANOVA) will be used to analyze the difference
among mean ion concentrations in the 4 groups. The Duncan multiple range test
will be applied to show the differences between groups.
7.4 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR OTHER
INTERVENTION TO BE CONDUCTED ON PATIENTS OR HUMANS
OR ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY.
NOT APPLICABLE.
7.5 HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR
INSTITUTION?
YES
8.0 LIST OF REFERENCES:
1. Nickel, chromium and iron levels in saliva of patients with simulated fixed orthodontic
appliances. Matos de Souza R, Menezes M. Angle Orthod. 2008; 78: 345-50.
2. Ion release from orthodontic brackets from three mouthwashes. Danaei SM et al. Am J
Orthod Dentofacial Orthop. 2011; 139: 730-34.
3. Metal ion release from new and recycled stainless steel brackets. Huang T, Ding S, Min
Y, Kao C. Eur J Orthod. 2004; 26: 171-77.
4. Biodegradation of orthodontic appliances. Part 1. Biodegradation of nickel and
chromium in vitro. Barret RD, Bishara SE, Quinn JK. Am J Orthod Dentofacial
Orthop. 1993; 103: 8-14.
5. In-vitro release of nickel and chromium from simulated orthodontic appliances. Park
HY, Shearer TR. Am J Orthod Dentofacial Orthop. 1983; 84: 156-59.
6. Clinical effects of chlorhexidine mouthwashes on patients undergoing orthodontic
treatment. Anderson GB, Bowden J, Morrison EC, Caffesse RG. Am J Orthod
Dentofacial Orthop 1997; 111: 606-12.
9.
SIGNATURE OF THE CANDIDATE
10.
REMARKS OF THE GUIDE
11.
NAME AND DESIGNATION OF
THE GUIDE
11.1
SIGNATURE
11.2
HEAD OF THE DEPARTMENT
11.3
SIGNATURE
11.4
REMARKS OF THE PRINCIPAL
11.5
SIGNATURE
DR. RABINDRA .S. NAYAK
PROF. AND HEAD OF DEPARTMENT OF
ORTHODONTICS AND DENTOFACIAL
ORTHOPEDICS
DR.RABINDRA .S. NAYAK
PROF. AND HEAD OF DEPARTMENT OF
ORTHODONTICS AND DENTOFACIAL
ORTHOPEDICS