DISSERTATION - SYNOPSIS
DEPARTMENT OF PEDODONTICS AND
PREVENTIVE CHILDREN DENTISTRY
A.B. SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES
DERALAKATTE,
MANGALORE
Rajiv Gandhi University of Health Sciences, Karnataka,
BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. /Name of the Candidate and
Address(In block letters) / Dr. SAURABH R JOSHI
(POST GRADUATE STUDENT)
DEPARTMENT OF PEDODONTICS AND PREVENTIVE CHILDREN DENTISTRY,A.B. SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE,
MANGALORE. – 575 018
2. / Name of the Institution / A.B. SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE,
MANGALORE. – 575 018
3. / Course of study and subject / MASTER OF DENTAL SURGERY. PEDODONTICS AND PREVENTIVE CHILDREN DENTISTRY
4. / Date of admission to course / MAY- 2007
5.
/ Title of the Topic:
“EVALUATION OF ORAL HEALTH STATUS, SALIVARY pH, SALIVARY FLOW RATE, TOTAL SALIVARY ANTIOXIDANT LEVELS IN ACUTE LYMPHOBLASTIC LEUKEMIA PATIENTS”
6.
7. / BRIEF RESUME OF THE INTENDED WORK
6.1) NEED FOR THE STUDY
Leukemia is essentially a malignancy with disseminated proliferation of immature or blast cells of the bone marrow, which replaces the normal marrow elements and tends to accumulate in various tissues of the body.1
Leukemia constitutes approximately 30% of all childhood cancers and Acute Lymphoblastic Leukemia (ALL) is the most common type of malignancy. Nearly 75% of the childhood leukemia’s are of ALL type-3. India has a population more than 1000 million, with more than 36% of its people under 15 years age. In India, childhood leukemia constitutes 2.3% of the cancer patients. Each year 6000 children in India develop ALL.2
Treatment modalities widely accepted in ALL children is chemotherapy alone and chemotherapy with irradiation.2 Chemotherapy associated toxicity compromises the oral mucosa and impedes repair of mucosal injury. Emesis can increase further mucosal damage.Oral dryness & ulceration seen are due to reduced salivary flow rate. Thus oral mucositis, oral mucosal dryness, oral ulceration and infection are seen commonly in ALL patients receiving chemo radiation therapy.3
Oxygen, an element indispensable for life, under certain situations, have severly deleterious effects on human body. Harmful effects of oxygen are due to formation of Reactive Oxygen Species(ROS) i.e free radicals, which are very unstable and highly reactive. To protect us against the oxidizing action of free radicals ,every individual has an army of antioxidants of proteinic nature.4
Thus in any diseased state, free radicals produced are quite higher. Cancer is one such diseased state in which free radicals are increased significantly. Increased free radical leds to consumption of antioxidants thereby decreasing levels of antioxidants.5 These changes in free radicals & antioxidant levels can also be seen in saliva of cancer patients.
Hence the study is required to establish the correlation of oral health, salivary pH, salivary flow rate and total antioxidant levels of saliva in ALL patients.
6.2) REVIEW OF LITERATURE
Salivary antioxidants & free radicals in cancer patients found a direct link between the two . The increase in free radicals i.e oxidative and nitrative stress, led to consumption and reduction of salivary antioxidants system,thus explaining the oxidative damage to nucleic acids & proteins, and possibly the promotion of cancer.5
“Antioxidants in cancer prevention” in animal models and epidemiological surveys showed vitamin E and B-carotene administration caused reversal of premalignant lesion and prevented malignancies in high risk group . Low intake of vitamin E and B- carotene is associated with higher cancer risk.
- Dental health status in ALL patients on maintenance therapy found decrease in
salivary flow rate of leukemic children than in control group of healthy children. Differences in salivary pH scores between the early maintenance duration & control group was observed to be in normal limits. 1
- Oral health status in children with ALL and lymphoma showed that 91.7% of ALL/lymphoma needed dental treatment. Long term oncologic therapy leds to abnormal dental and craniofacial development. Study stressed on dental care relates to the improvement in chewing ability of the patient to achieve sufficient enteral nutrition.6
- Dental health status in ALL children receiving chemoradiation therapy found increased caries and mucositis than in ALL children where chemoradiation was yet to start.2
6.3)OBJECTIVES OF THE STUDY-
1) To observe the oral health status in children with ALL.
2) To evaluate salivary pH and salivary flow rate in children with ALL.
3) To evaluate the total salivary antioxidant levels in children with ALL.
Thus, co-relating the above findings with each other
MATERIALS AND METHODS-
90 ALL patients between age group of 4-10 yrs of both sexes attending various cancer institute for treatment of ALL will be part of study and 30 normal healthy children of same age group will be taken as control group.
7.1 STUDY DESIGN-
90 ALL patients are broadly divided onto 3 groups,
Group 1 / 30 ALL patients without chemotherapy
Group 2 / 30 ALL patients upto 1-2 weeks of chemotherapy
Group 3 / 30 ALL patients with more than 2 weeks of chemotherapy.
Control Group
Group 4 / (Control group) 30 normal healthy children
INCLUSION CRITERIA-
Children who are cooperative and suffering from Acute Lymphoblastic Leukemia.
EXCLUSION CRITERIA-
a. Uncooperative children.
b. Parents of the child not willing for the child’s oral health checkup & saliva
collection.
b. Children reported from any other systemic disease and on medication for th same.
7.2) Method of collection of data
1. Oral hygiene status will be evaluated using OHI-S index,7
Modified Gingival Index (MGI) to record the gingival status,7
WHO Oral Toxicity Scale for oral mucositis, dental caries.8
2. Un-stimulated salivary flow rate will be measured after collecting saliva for 5 min.
· Unstimulated saliva (1ml – 1.5ml) will be collected in the morning hours and flow rate will be measured after a period of 1 hour without eating or drinking. Sitting in the coachman position, the patient passively drools into a funnel inserted into a graduated cylinder for 5 min. The volume of saliva collected in the cylinder after 5 minutes is divided by 5 to determine the unstimulated salivary flow rate.9
· The collected saliva will be stored in glass or plastic vials, in the chiller at 4◦C temperature and the evaluation will be done within 24hours.
3. The Salivary total antioxidant capacity will be measured by Phosphomolybdic
acid method.10
4. The salivary pH will be evaluated using pH meter.
The above data will be subjected to statistical tests like Student’s ‘t’ test and
ANOVA.
7.3) Does the study require any investigations or interventions to be conducted on patients or other humans or animals?
Yes, the study requires collection of saliva which will be performed after informed consent from the parents /guardian of children.
7.4) Does the study require any ethical clearance?
Yes, the study requires the ethical clearance and the document is to be enclosed
8. / REFERENCES-
1. Sepet E, Aytepe Z, Gulhan A, Yalman N. Acute lymphoblastic leukemia: dental health of children in maintenance therapy. The Journal of Clinical Pediatric Dentistry 1998;22(3): 257-260.
2. Nasim V S, Shetty Y R, Hegde A M. Dental health status in children with Acute Lymphoblastic Leukemia. The Journal of Clinical Pediatric Dentistry 2007;31:210-212.
3. Schubert MM, Epstein JB, Peterson. Oral complications of cancer therapy. In: Yageila and Neidiel. Textbook of Pharmacology for dental students. 2nd ed.
4. Bagchi K and Puri S. Antioxidants and free radicals in health and disease.
Eastern Mediterranean Health Journal 1998;4(2):350-360.
5. Nagler R. Salivary analysis in oral cancer patients,original article.
6. Dodan C , Haytac C, Antmen B. Oral Health Status in Children with Acute Lymphoblastic Leukemia and Lymphoma. Turk J Haematol 2001;18(3):179-183
7. World Health Organization. Oral health survey : Basic method 4th ed.
Geneva. WHO ;1997
8. World Health Organization. Oral Toxicity Scale : Geneva. WHO;2004.
9. McDonald RE, Avery DR, Dean JA. Dentistry for the Child and
Adolescent. 8th ed., St. Louis: Mosby, 2004.
10. Prieto, Pineda. Spectrophotometric quantification of antioxidant capacity by formation of phosphomolybdenum complex. Analytical biochemistry Nov 1999: 337-341.
11. Crist WM, Smithson WA. The Leukemias. In: Nelson WE, Behrman , Kliegman et al .Textbook of Pediatrics.16th ed.
9. / Signature of the candidate
10. / Remarks of the guide
11. / Name and designation( in block letters) of
11.1 Guide / PROF (DR) AMITHA M. HEGDE
PROFESSOR AND HEAD OF THE DEPARTMENT
11.2 Signature
11.3 Co-Guide / DR.SUCHETHA SHETTY
DEPT.OF BIOCHEMISTRY
K.S.HEGDE MEDICAL ACADEMY
11.4 Signature
11.5 Head of the department / PROF (DR) AMITHA M. HEGDE
PROFESSOR AND HEAD OF THE DEPARTMENT
11.6 Signature
12. / 12.1 Remarks of the chairman and principal
12.2 Signature / PROF(DR) B.RAJENDRA PRASAD
DEAN & PRINCIPAL