Post graduate student, department of conservative dentistry and endodontics



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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.DAAMAN NAGPAL

POST GRADUATE STUDENT,

DEPARTMENT OF CONSERVATIVE

DENTISTRY AND ENDODONTICS,

COLLEGE OF DENTAL SCIENCES,

DAVANGERE-577004.

KARNATAKA.


2.


NAME OF THE INSTITUTION

COLLEGE OF DENTAL SCIENCES,

DAVANGERE-577004,KARNATAKA



3.



COURSE OF STUDY AND SUBJECT



MASTER OF DENTAL SURGERY IN CONSERVATIVE DENTISTRY AND ENDODONTICS

4.


DATE OF ADMISSION TO COURSE

14/5/2012


5.

TITLE OF THE TOPIC

IN VIVO STUDY -DETERMINATION OF EFFICACY OF PULSE OXIMETRY IN ASSESSMENT OF PULPAL INFLAMMATION”


6.



BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY:

Diagnosis is the correct determination, discriminative estimation and logical appraisal of conditions found during examination as evidenced by distinctive signs, marks and symptoms. Correct treatment begins with a correct diagnosis1.The assessment of pulp vitality is a crucial diagnostic procedure in practice of endodontics.

Different methods of diagnosis are history, transillumination, palpation, percussion, radiographs, thermal and electrical sensitivity tests. Pulp vitality testing is an important aid in diagnosis of pulpal and periapical pathosis for proper endodontic diagnosis.2

The various methods to determine pulp vitality are thermal and electrical stimulation, anaesthetic testing and test cavity.4 Recent advances in endodontic diagnosis involves pulse oximetry and laser Doppler flowmetry. Pulse oximetry determines vascular circulation which is a more definite determinant of pulpal vitality than determination of neural responses. Pulse oximetry is a non invasive method of determining pulp vitality. It measures blood flow by sending light of a known wavelength (640 nm) through pulpal tissues and determines pulse rate and functional oxyhemoglobin saturation (% SaO2).7

The aim of our present study is to determine the clinical diagnosis of pulpal inflammation based on pulp oxygenation rates measured by pulse oximetry.7






7

8

6.2 REVIEW OF LITERATURE:

A study was conducted to evaluate the efficacy of a new custom made pulse oximeter dental probe in comparison to electrical and thermal test for assessing pulp vitality. 80 single rooted incisors, canines and premolars in patients were taken and they underwent electrical sensitivity tests, thermal sensitivity tests and pulse oximetry. A pulse oximetry reading of 75- 85% was taken as positive response and a reading of less than 75% was taken as negative response. It was shown that the sensitivity and specificity of pulse oximetry was higher than both electrical and thermal sensitivity testing. Thus it was concluded that custom made pulse oximeter dental probe is an effective, accurate and objective method of evaluating pulp vitality.3

A study was conducted to compare the efficacy of electrical, thermal and pulse oximetry methods for assessing pulp vitality in recently traumatized maxillary incisor teeth. Readings for pulp vitality for 17 recently traumatized maxillary incisors were taken with pulse oximeter, electrical pulp tester and thermal pulp tester. The proportion of teeth showing a positive response to thermal/electrical pulp tests increased from day 0 to 3 months whereas pulse oximeter readings remained constant from day 0 to 6 months. It was concluded that pulse oximeter is an effective, objective method of evaluating pulp vitality in recently traumatized permanent teeth.4

A study was conducted to evaluate the use of pulse oximetry as a test for pulp vitality by comparing in the same patient the level of oxygen saturation in index finger and maxillary incisor and canine teeth without clinically detectable pulp inflammation.17 male and 17 female patients between 26 and 38 years of age participated and a total of 32 maxillary central incisors and 32 canines were evaluated. 10 root canal treated teeth were used as negative control group. Pulse oximetry readings were taken from index finger and then teeth were subjected to thermal tests followed by pulse oximetry. The value of 90.69% showed vital pulps and SaO2 (oxygen saturation) of fingers was 95% Thus it was concluded that pulse oximetry can be used as a potential aid to test pulp vitality.5

A study was conducted to assess pulp inflammation based on pulp oxygenation rates. Premolars and molars of 60 human subjects were included in the study .The clinical diagnosis of reversible pulpitis, irreversible pulpitis and pulpal necrosis was determined on the basis of clinical signs and symptoms, radiographs and dental history. Pulse oximetry was used to determine blood flow of the pulp. Approximate % SaO2 (percentage of oxygen saturation) in reversible pulpitis was 87% irreversible pulpitis was 83% and pulpal necrosis was 75% whereas normal pulp gave 92%. This study confirmed and concluded that pulpal pathology has a lower % SaO2 than normal pulp.6

A study was conducted to compare the efficacy of a custom made  pulse  oximeter probe with digital electric pulp tester, cold spray, and rubber cup for assessing pulp vitality .Twenty-four single-canal mandibular  premolars  needing endodontic treatment were selected.  The selected teeth were pulpally tested with 4 kinds of tests including pulse oximetry, the electric test, cold spray, and the rubber cup. The sensitivity of pulse oximetry, a rubber cup, electric test, and cold spray was 0.93, 0.60, 0.60, and 0.53, respectively. The specificity of these tests was 1.00, 0.55, 0.22, and 0.66, respectively. It was concluded that pulp testing by using pulse oximetry is more reliable than the electric test, rubber cup, and cold spray. The custom-made pulse oximeter dental  probe is an effective and objective method for pulp vitality assessment.7


6.3 Aim and Objective Of the Study :

The purpose of the present in vivo study is to investigate a correlation between pulp oxygenation i.e. Percentage of oxygen saturation (% SaO2 ) rates and clinical diagnosis of reversible pulpitis, irreversible pulpitis and pulpal necrosis.


Materials and Method:

7.1 Source Of Data:

Ninety human subjects of either gender with or without pain sensation in premolars and molars (maxillary or mandibular) in the age group of 20 – 60 years will be selected from the OPD of Department Of Conservative Dentistry And Endodontics, College Of Dental Sciences, Davangere. The possible risks and discomforts will be explained to the patients and informed consent forms will be signed by the patients. The patients will be divided into three groups of 30 patients each based on clinical diagnosis which will be made on the basis of history of pain, palpation, percussion, thermal tests, electric test, and radiographs.



Criteria for diagnosis

Healthy pulp – no past history of pain, a normal cold response, and no clinical or radiographic signs and symptoms.

Reversible pulpitis – no past history of pain, a pronounced response to cold, pain subsides quickly, and causative etiology for reversible pulpitis (cervical abrasion and initial dental caries).

Irreversible pulpitis – a past history of severe, dull, lingering, or spontaneous pain and pain can be elicited on heat. (deep caries involving pulp).

Pulpal necrosis – a past history of severe, dull, lingering, or spontaneous pain; no thermal response; pain on percussion; pain on palpation.

Group 1- reversible pulpitis (30 patients)

Group 2- irreversible pulpitis (30 patients)

Group 3- pulpal necrosis (30 patients)



Positive and negative control- all patients in each group should have a healthy tooth with normal pulp that serves as positive control and an endodontically treated tooth with full crown restoration that serves as negative control group. Pulse oximetry readings will be collected from index fingers of all patients of all groups and they will serve as index finger group.

Positive control – 90 patients (including all three groups).

Negative control- 90 patients (including all three groups).

Index finger group- 90 patients (including all three groups).5

Then the pulse oximetry findings will be noted down.

Pulse oximeter (Hygeia, model H100B).

Electrical pulp tester (Parkell pulp vitality tester, model PT-20, Farmingdale , NY 11735 USA).

Thermal pulp testing – hot gutta percha and difluordichlormethane (Endo frost, Roeko).
7.2 Method Of Collection Of Data:

90 patients of either gender in the age group of 20 – 60 years will be selected using simple random sampling technique and clinical diagnosis of reversible pulpitis, irreversible pulpitis and pulpal necrosis will be made.



Inclusion criteria

  1. Patients should volunteer to take part in study.

  2. Patient having intact crowns or restorations no larger than 2mm away from the area to be tested will be chosen for clinical examination.

  3. Patient should have a healthy tooth with normal pulp to serve as a positive control.

  4. Patient should have an endodontically treated tooth with full crown restoration to serve as a negative control group.

Exclusion criteria

  1. Patients suffering from syndromes of tooth impairment.

  2. Patients with teeth affected by dental trauma and cavities.

  3. Patient with crown discoloration indicative of trauma.

  4. Patient with periodontal change (pockets >3mm mobility > 1mm, gingival edema).

  5. Patient with orthodontic braces or prosthetic crowns.

Statistical analysis

Results will be subjected for appropriate statistical analysis.

One way ANOVA will be used for simultaneous multiple group comparison followed by post hoc Tukey HSD test for intergroup comparison.

Student’s unpaired t test will be used for group wise comparison.



7.3: Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.

Yes, the study requires interventions conducted on patients. For diagnosis of pulpitis electrical pulp testing will be done where an electrode is placed on the tooth and current is passed through it to determine response. Thermal pulp testing will be done using a cotton pellet soaked in endofrost on the tooth to detect inflammation. Pulse oximeter will then be used .The teeth to be investigated will be isolated and pulse oximeter sensors will be placed parallel to each other on the vestibular and lingual faces of the teeth. The sensors will be placed in such a way that light travels from facial to lingual surfaces through the middle of the crown . This will determine the vascular blood flow and oxygen saturation of the pulp. All the above mentioned tests are non invasive methods of assessing pulpal status.



7.4 : Has ethical clearance been obtained from your institution in case of 7.3

YES


References

  1. B.Suresh, V.Gopi Krishna. Grossman’s Endodontic Practice - 12th Edition. Pg:2

  2. Hargreaves.KM, Cohen S. Cohen’s Pathways of The Pulp- 10th Edition. Pg 2-20

  3. Gopikrishna V, Tinagupta K, Kandaswamy D. Evaluation of efficacy of a new custom made pulse oximeter dental probe in comparison with electrical and thermal test for assessment of pulp vitality. J Endod. 2007 Apr;33(4):411-4.

  4. Gopikrishna V, Tinagupta K, Kandaswamy D. Comparison of electrical ,thermal and pulse oximetry methods for assessing pulp vitality . J Endod. 2007 May;33(5):531-5.

  5. Calil E, Caldeira CL, Gavini G, Lemos EM. Determination of pulp vitality in vivo with pulse oximetry. Int Endod J. 2008 Sep;41(9):741-6.

  6. Setzer FC, Kataoka SH, Natrielli F, Gondim Junior E, Caldeira CL.Clinical diagnosis of pulp inflammation based on pulp oxygenation rates measured by pulse oximetry. J Endod. 2012 Jul;38(7):880-3.

  7. Dastmalchi N, Jafarzadeh H, Moradi S. Comparison of the efficacy of a custom-made pulse oximeter probe with digital electric pulp tester, cold spray, and rubber cup for assessing pulp vitality. J Endod. 2012 Sep;38(9):1182-6.







9.

SIGNATURE OF CANDIDATE



10.

REMARKS OF THE GUIDE




11.

NAME & DESIGNATION OF (IN BLOCK LETTERS)

11.1 GUIDE


11.2 SIGNATURE


DR. DHANYAKUMAR N.M, M.D.S

PROFESSOR AND HEAD DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,

COLLEGE OF DENTAL SCIENCES ,

DAVANGERE-577004

KARNATAKA





11.3 CO-GUIDE

(IF ANY)
11.4 SIGNATURE







11.5 HEAD OF DEPARTMENT
11.6 SIGNATURE


DR. DHANYAKUMAR N.M, M.D.S

PROFESSOR AND HEAD DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,

COLLEGE OF DENTAL SCIENCES ,

DAVANGERE-577004



KARNATAKA.

12.

REMARKS OF THE CHAIRMAN & PRINCIPAL

12.2 SIGNATURE





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