RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.
ANNEXURE – II
PROFORMA FOR THE REGISTRATION
OF
SUBJECT FOR DISSERTATION
DR.ROOPALAKSHMI N.
1ST YEAR MDS
DEPARTMENT OF PERIODONTOLOGY
2013-14
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND HOSPITAL
BANGALORE- 562157
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE,KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. NAME OF THE CANDIDATE AND Dr. ROOPALAKSHMI N.
ADDRESS (IN BLOCK LETTERS) POST GRADUATE STUDENT
DEPARTMENT OF PERIODONTOLOGY
KRISHNADEVAYARA COLLEGE OF
DENTAL SCIENCES& HOSPITAL, KRISHNADEVARAYANAGAR, HUNASAMARANAHALLI, VIA YELAHANKA, BANGALORE-562157 KARNATAKA
2. NAME OF THE INSTITUTION KRISHNADEVARAYA COLLEGE OF
DENTAL SCIENCES
BANGALORE- 562157
KARNATAKA
3. COURSE OF STUDY AND SUBJECT MASTER OF DENTAL SURGERY IN
PERIODONTOLOGY
4. DATE OF ADMISSION 3rd JUNE 2013
5. TITLE OF THE TOPIC “TREATMENT OF CERVICAL HYPERSENSITIVITY IN FLUOROSED
AND NON-FLUOROSED TEETH
USING DIODE LASER AND DESENSITISING
AGENT- AN IN VIVO STUDY”
6. BRIEF RESUME OF INTENDED WORK
6.1. Need for study
Dentin hypersensitivity is a painful response of the tooth to different stimuli such as brushing, acidic diets, occlusal overload and thermal changes; characterised by acute, non-spontaneous, short- or long- lasting pain that appears suddenly in a specific location, which cannot be attributed to any other dental pathology.1
Various treatment modalities used for the treatment of hypersensitivity include most commonly, the use of topical agents such as fluorides, strontium acetate, calcium sodium phosphosilicate paste, calcium hydroxide paste, potassium oxalate, silver nitrate, fluoride iontophoresis, varnishes, dentin adhesives, etc, to occlude the exposed tubules. Other attempts to treat hypersensitivity include, placement of restorations, desensitisation of the pulpal sensory nerves using potassium nitrate toothpastes. More recently lasers have been tried due to their decided advantages.
Among several lasers, diode lasers under specific parameters show less damaging changes to the root surface and minimal temperature rise on the irradiated area, making them a more efficient and safe option.2 Lasers when used on dentin induce narrowing of dentinal tubules, with concomitant reduction of the symptoms of hypersensitivity,3 lasting for extended periods of time.1 Adjunctive use of sodium fluoride desensitising gel with diode lasers, has given instantaneous and prolonged results, than lasers alone.4
Fluorosis is a form of dental hypoplasia, where in the affected teeth show wider dentinal tubules and slower rates of mineralisation of the tooth structure.5,6 This histological finding in fluorosed teeth leads to higher tooth sensitivity frequency and more number of sensitive teeth per subject.7
Based on this rationale, there is a need to evaluate the efficacy of lasers on hypersensitive fluorosed teeth. Therefore, the aim of the present clinical study will be to compare the effectiveness of treatment of dentinal hypersensitivity in fluorosed and non fluorosed teeth with diode lasers and potassium nitrate desensitising agent.
6.2. Review of literature
Theodoro et al2 conducted a study to compare the effects of Er:YAG and Diode lasers, irradiated using different parameters on the root surface and on intrapulpal temperature. Results showed that diode lasers did not induce high pulpal temperatures and produced lesser surface irregularities.
Murisilo8 conducted a study to compare the demographic and clinical features of tooth sensitivity in subjects with and without fluorosis. Results concluded that there was a higher tooth sensitivity frequency and number of sensitive teeth per subject in fluorosis group. Also changes in the dentinal tubule size observed in case of dentinal fluorosis contributed to the dentinal hypersensitivity.
Umberto et al3 conducted a study to assess the efficacy of a diode laser alone and in combination with topical sodium fluoride gel in the treatment of dentinal hypersensitivity. Results showed that, percentage relief of symptoms on air stimulation when lasers and desensitising agents were used was 25.04% compared to 22.35% when only lasers were used.
Vieira et al5 conducted a study on fluoride effect on human dentin ultrasound velocity (elastic modulus) and tubule size. Results concluded that dentin fluorosis showed wider dentinal tubules due to influence on crystal growth, odontoblast or dentin mineralisation. Dental fluorosis (DF) severity is an indication of dentin mechanical properties. A stable crystallite is formed when hydroxyl group is substituted by the fluoride ion in hydroxyapatite.2 Hence shows higher chances of hypersensitivity in flourotic teeth.
Sicilia et al1 conducted a study to evaluate the efficacy of 810 nm diode laser, and 10% potassium nitrate bioadhesive gel application on treatment of dentin hypersensitivity. Results showed a significant reduction in the symptoms in a short time and lasted for a significant period of time. Promising results were seen with lasers than with the desensitising gel. Further studies using both simultaneously and for longer recall periods were recommended.
Umana et al4 conducted a study to evaluate the effect of diode laser at different parameters on the dentinal tubules. Results concluded that, 0.8W and 1W for 10seconds in a continuous mode were able to seal the dentinal tubules and these parameters can be considered harmless for the pulp vitality.
6.3. Objectives of study:
· To compare the effect of diode laser and potassium nitrate together, for the treatment of dentinal hypersensitivity in fluorosed and non fluorosed teeth.
· To compare the efficacy of diode laser alone for the treatment of dentin hypersensitivity in fluorosed and nonfluorosed teeth.
· To assess which treatment method is better; lasers alone or lasers with potassium nitrate gel.
7. MATERIALS AND METHODS:
7.1. Source of data:
Patients visiting the Out Patient Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital and satisfying the inclusion and exclusion criteria will be selected for the study.
7.2. Method of Collection of Data (including sampling procedures, if any):
Sample size:
This is a prospective, randomized clinical study. 45 patients with fluorosis and 45 patients without fluorosis (A total of 90 patients); all having symptoms of dentinal hypersensitivity will be included in the study.
The selected subjects will be divided into six groups as given below.
GROUP 1- Fluorosed Group (n=45)
GROUP 1A: Patients with healthy fluorosed teeth, receiving desensitising agent (potassium nitrate) treatment. (n=15)
GROUP 1B: Patients with healthy fluorosed teeth, receiving diode laser treatment. (n=15)
GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate) treatment. (n=15)
GROUP 2- Non Flourosed Group (n=45)
GROUP 2A: Patients with healthy non fluorosed teeth receiving desensitising agent (potassium nitrate) treatment. (n=15)
GROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment. (n=15)
GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate) treatment. (n=15)
Selection criteria:
Inclusion criteria:
1. Positive response for hypersensitivity testing.
2. Presence of non-carious cervical lesions in the enamel.
3. Fluorosed teeth- Fluorotic enamel staining confirmed by clinical examination.
4. Non fluorosed teeth - Confirmed by clinical examination.
Exclusion criteria:
1. Presence of any systemic diseases
2. Patients undergoing any form of restorative endodontic, orthodontic treatments or crown restorations
3. Local defects including caries and fractures.
4. Acute pain conditions (like apical periodontitis, periapical abscess)
5. Presence of periodontal disease or a history of periodontal treatment in last 6 months.
6. Usage of desensitising toothpaste or mouth rinse in the last 4 weeks.
7. Patients allergic to ingredients used in the study product.
8. Teeth with intrinsic stains caused by other reasons.
Sampling Technique:
45 patients for the fluorosis group and 45 patients for the non flourosis group (totally 90 patients) will be selected, all showing positive response for hypersensitivity.
The 90 selected subjects will be divided into six groups as given below.
GROUP 1- Fluorosed Group (n=45)
GROUP 1A: Patients with healthy fluorosed teeth receiving desensitising agent (potassium nitrate) treatment. (n=15)
GROUP 1B: Patients with healthy fluorosed teeth receiving diode laser treatment. (n=15)
GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate) treatment. (n=15)
GROUP 2- Non Flourosed Group (n=45)
GROUP 2A: Patients with healthy non fluorosed teeth receiving desensitising agent (potassium nitrate) treatment. (n=15)
GROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment. (n=15)
GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate) treatment. (n=15)
All subjects will be randomly assigned to the three groups, and will be treated within 24 hours with scaling and root planing using hand and ultrasonic instruments, followed by a single episode of laser therapy with or without potassium nitrate desensitising agent application. Oral hygiene instructions individualized for every subject will be given at the first appointment.
The teeth selected as experiment in patients of GROUP 1A and GROUP 2A will be subjected to treatment using a 5% potassium nitrate desensitising agent for 60 seconds per tooth and the same will be washed off with water thereafter.
The teeth selected as experiment in patients of GROUP 1B and GROUP 2B will be subjected to irradiation treatment using a diode laser with a wavelength of 810 nm and a fibre tip, at an output power of 1W, continuous wave mode, each tooth irradiated for 10 seconds, fibre tip placed tangentially to the tooth surface and 1 mm away from it.
The teeth selected as experiment in patients of GROUP 1C and GROUP 2C will be treated by the application of 5% potassium nitrate desensitising agent for 1 minute followed by irradiation treatment using a diode laser with a wavelength of 810 nm and a fibre tip, at an output power of 1W, continuous wave mode, each tooth irradiated for 10 seconds, fibre tip placed tangentially to the tooth surface and 1 mm away from it.
Patients will be advised to use a non-fluoridated toothpaste for the rest of the duration of the study.
· During the therapy mentioned above, rating of dentin hypersensitivity using Visual Analogue Scale (ranging from 0- 10; 0 indicating least symptoms and 10 indicating most symptoms) when tested with a blast of air, cold water jet and an electrical tactile stimulator will be recorded at baseline, 15minutes after treatment, 1week, 2months, 3 months.
· Air stimulus- Three way syringe with an air pressure set between 45-60 psi, at a distance of 1-3 mm and perpendicular to tooth surface, for 1 second per tooth. Adjacent teeth covered with operator’s fingers.
· Cold water stimulus- 1 ml of ice cold water applied over the tooth surface for 1 second per tooth. Adjacent teeth covered by operator’s fingers or cotton rolls.
· Electrical tactile stimulator (scratch-o-meter)- The pressure sensitive device will indicate the minimum pressure required to stimulate discomfort to the patient. A higher pressure in the recall visits after treatment will indicate relief and improvement in symptoms of hypersensitivity.
Statistical tests:
If the data distribution is according to the normal curve, the mean values between the fluorosis and non- fluorosis groups will be compared using student t-test; and the values within the same group at different recall visits will be compared using ANOVA.
If the data distribution is skewed, the mean values between the fluorosis and non- fluorosis groups will be compared using Mann-Whitney U-test; and the values within the same group at different recall visitis will be compared using Kruskal Wallis test.
A ‘p’ value of <0.05 will be considered stasistically significant.
7.3. Does the study require any investigation or interventions to be conducted on the patients or other humans or animals? If so, please describe briefly
Yes. The study requires application of diode laser and potassium nitrate desensitizing gel during laser therapy in test sites of patients. A signed informed consent will be obtained from the patients for the same.
7.4. Has ethical clearance been obtained from your institution in case of 7.3?
Yes. A copy of the same has been enclosed.
8. REFERENCES:
1.Sicilia A, Cuesta-Frechoso S, Sua ´rez A, Angulo J, Pordomingo A, De Juan P. Immediate efficacy of diode laser application in the treatment of dentine hypersensitivity in periodontal maintenance patients: a randomized clinical trial. J ClinPeriodontol 2009; 36: 650–660.
2.Theodoro L.H, Haypek P, Bachmann L, Garcia V. G, Sampaio J. E. C, Zezell D. M, et al.Effect of Er:YAG and diode laser in the irradiation on the root surface: Morphological and thermal analysis. J Periodontol 2003; 74: 838-843.
3. Umana M, Heysselaer D, Tielemans M,Compere P,Zeinoun T, Nammour S. Dentinal Tubules Sealing by Means of Diode Lasers (810 and 980nm): A Preliminary In Vitro Study. Photomed. Laser Surg. 2013; 31: 1–8.
4. Umberto R, Claudia R, Gaspare P, Gianluca T, Alessandro D. V. Treatment of Dentine Hypersensitivity by Diode Laser: A Clinical Study. Int J Dent 2012; 2012: 858950.
5. Vieira APGF, Hancock R, Dumitriu M, Limeback H, Grynpas MD.Fluoride’s effect on human dentin ultrasound velocity (elastic modulus) and tubule size. Eur J Oral Sci 2006; 114: 83–88.
6. Aoba T, Fejerskov O. Dental Fluorosis: Chemistry and Biology. Crit Rev Oral Biol Med 2002; 13: 155.
7. Tonguca M. O, Ozata Y, Sertb T, Sonmezc Y, Kirziogluat F.Y. Tooth sensitivity in fluorotic teeth. Eur J Dent 2011; 5: 273-280.
8. Murisilo A. L, Rodrigues J. R, Borges A. B. Effect of the clinical application of the GaAlAs laser in the treatment of dentin hypersensitivity. Journal of Clinical Laser Medicine and Surgery 2003; 21: 291-296.
9. LadalardoT.C.C.G.P, Pinheiro A, Campos R.A.C, Brugnera A,Zanin F,Albernaz P.L.M, et al.Laser Therapy in the Treatment of Dentine Hypersensitivity. Braz Dent J 2004; 15: 144-150.
10. Waidyasekera K, Nikaido T, Weerasinghe D, Watanabe A, Ichinose S, Tay F et al. Why does fluorosed dentine show a higher susceptibility for caries: An ultra- morphological explanation. J Med Dent Sci 2010; 57; 17-23.
11. West NX, Addy M, Jackson RJ, Ridge DB. Dentine hypersensitivity and the placebo response. A comparison of the effect of strontium acetate, potassium nitrate and fluoride toothpastes. J Clin Periodontol 1997; 24: 209-215.
12. Benetti AR, Franco EB, Franco EJ, Pereira JC. Laser therapy for dentin hypersensitivity: A critical appraisal. J Oral Laser Applications 2004; 4: 271-278.
13. Barlow AP, He J, Tian C, Jeffery P, Mason SC, Tai BJ et al. A Comparative Evaluation of the Efficacy of Two Novel Desensitising Dentifrices. Int J Dent 2012; 2012: 896143.