Rajiv gandhi university of health sciences bangalore, karnataka



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

MASTER OF DENTAL SURGERY (M.D.S.)

DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY

2013-2016

A.E.C.S. MAARUTI COLLEGE OF DENTAL SCIENCES & RESEARCH CENTRE,

BANGALORE.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE-II

1


NAME OF THE CANDIDATE AND ADDRESS

DR. SHILPA I.G

A.E.C.S. Maaruti College of Dental Sciences

& Research Centre, No. 108, Tank Bund Road, Hulimavu, Bangalore-560 076.


2

NAME OF THE INSTITUTION

A.E.C.S. Maaruti College of Dental Sciences

& Research Centre, Bangalore,


3

COURSE OF THE STUDY AND SUBJECT

MASTER OF DENTAL SURGERY(MDS)

PEDODONTICS AND PREVENTIVE DENTISTRY


4

DATE OF ADMISSION TO THE COURSE



17th JUNE 2013


5

TITLE OF THE TOPIC

Evaluation and comparison of Biodentine, MTA and Formocresol as a pulpotomy agent in primary molar –IN VIVO Study

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

6.1 NEED FOR THE STUDY:

Pulpotomy is one of the most frequently used treatments for retaining cariously involved primary molars. Though various materials have been used in pulpotomy, Formocresol is the most widely used.1 However, it has many disadvantages like cytotoxicity, pulpal inflammation and necrosis, systemic disturbances, mutagenic and carcinogenic potential and immunologic responses.(2-5)

Since the mid—1990s MTA has been recognized as the reference material for pulpotomy in primary teeth and partial pulpotomy in permanent teeth.6 MTA is biocompatible, prevents micro leakage and promotes regeneration of original tissues with better marginal integrity. Although it has excellent properties there are some disadvantages like difficult manipulation, long setting time, high pH and low compressive strength.(7-12)

To overcome all these disadvantages newer material Biodentine has been introduced, it is new bioactive cement with dentin-like mechanical properties, which can be used as a dentin substitute on crowns and roots. It has a positive effect on vital pulp cells and stimulates tertiary dentin formation. In direct contact with vital pulp tissue it also promotes the formation of reparative dentin. It is biocompatible, has short setting time and better handling properties.(13-15) As there is a paucity of studies on Biodentine, this study will be done to evaluate and compare Clinically and radigraphically Biodentine with Formocresol and MTA pulpotomy.






6.2 REVIEW OF LITERATURE

An animal study was done to compare the response of pulp after a pulpotomy using Biodentine, white mineral trioxide aggregate and Formocresol in primary pig teeth. A total of 180 primary teeth from 9 healthy 4-month-old female pigs were divided into 3 experimental periods (7, 28, and 90 days) for each material used for pulpotomy. Results showed a significant difference in both Biodentine and WMTA as compared to Formocresol in terms of inflammatory cell response and hard tissue formation. It was concluded that both Biodentine and white mineral trioxide aggregate are suitable and biocompatible materials for pulp therapy in primary teeth of pigs.16

A study was done to evaluate Biodentine bioactivity by studying its effects on pulp progenitor cells activation, differentiation and dentin regeneration in human tooth cultures. After tooth pulp capping with Biodentine, dense mineralized foci including sequestered cells were observed after 14 days just beneath the material in the pulp wound area. Collagen I, Osteonectin and Dentin Sialoprotein were expressed in the mineralized matrix and in the sequestered cells expressed Nestin. It was concluded that Biodentine induced odontoblast differentiation from pulp progenitor cells.17

A study was done to assess the biological effects of Biodentine for use in pulp-capping treatment, on pseudo-odontoblastic (MDPC-23) and pulp (Od-21) cells and to evaluate the effects of Biodentine and mineral trioxide aggregate (MTA) on gene expression like Runx2,Colla1,Sppl and Alp in cultured spheroids and Cell differentiation was investigated by RT-qPCR .The results showed that Biodentine and MTA may modify the proliferation of pulp cell lines and their effects may fluctuate over time, depending on the cell line considered. A similarity has observed between Biodentine and MTA validating the indication for direct pulp-capping 14

A study was conducted to evaluate the biological effect of Biodentine on immortalized murine pulp cells (OD-21). Cell proliferation was determined by MTS colorimetric assay after 2, 3 and 5 days after stimulation .The expression of several biomolecular markers was analysed withRT-qPCR and alkaline phosphatase activity. Alizarin red staining was used to assess and quantify biomineralization. The results showed that Biodentine is bioactive because it increased OD-21 cell proliferation and biomineralization and concluded that, Biodentine can be considered as a suitable material for clinical indications of dentin-pulp complex regeneration, such as direct pulp capping.13

A study was done on 28 human permanent molars to evaluate response of human dental pulp capped with Biodentine and mineral trioxide aggregate. Samples were mechanically exposed and divided into 3 groups Biodentine, MTA and control group Assay of periapical response and clinical examination were performed. After 6 weeks, the teeth were extracted, stained with haematoxylin-eosin and histologically scored. Results showed that majority of specimens showed complete dentinal bridge formation and an absence of inflammatory pulp response and it was concluded that Biodentine had a similar efficacy to MTA with respect to pulp capping.18






6.3 OBJECTIVES OF THE STUDY:

  1. Clinical and radiographic evaluation of Formocresol pulpotomy on primary teeth at

3 and 6 month intervals.

  1. Clinical and radiographic evaluation of MTA pulpotomy on primary teeth at

3 and 6 month intervals.

  1. Clinical and radiographic evaluation of Biodentine pulpotomy on primary teeth at

3 and 6 month intervals.

  1. Clinical and radiographic comparison of Formocresol, MTA and Biodentine pulpotomy on primary molars at 3 and 6 month intervals.






7. MATERIALS AND METHODS:

7.1 Source of Data

The study will be conducted on sixty primary teeth in children aged between 4-7 years visiting the Department of Pedodontics and Preventive Dentistry at A.E.C.S Maaruti College of Dental Sciences and Research Centre, Bangalore



.

INCLUSION CRITERIA

1. Healthy Co-operative patient.

2. Carious exposure of vital pulp.

3. No clinical and radiographic evidence of pulp degeneration.

4. Presence of 2/3rd of root.

5. Teeth which can be restored.

6. Children with prior parental consent


.

EXCLUSION CRITERIA

1. Continuous pain.

2. Presence of a swelling or a sinus tract in relation to tooth.

3. Exfoliating tooth.

4. Presence of inter radicular bone loss.

5. Evidence of internal resorption



.

MATERIALS REQUIRED

1. Mouth mirror & probe

2. Pair of tweezers

3. Rubber dam

4. Radiographs

5. Local anaesthesia

6. 2 ml disposable syringes

7. Suction tips

8. Gloves & mouth mask

9. Aeratorhand piece

10. No. 330 diamond bur, No. 245 diamond bur S.S White

11. Small and medium sized spoon excavators

12. Formocresol 1:5 ratio (Pharmadent Remedies Pvt Ltd)

13. Biodentine (septodentPvt.Ltd)

14. Mineral trioxide aggregate cement (AugelusInd.de.prod)

15. Cotton

16. Condenser

17. Mixing pad and spatula

18. Zinc oxide Eugenol cement

19. Glass Ionomercement( GC Corporation Tokyo, Japan)

20. Stainless steel crowns (3M pretrimmed and precontoured)

21. Amalgam carrier






7.2 METHODOLOGY

The 60 teeth considered for the study will be radiographed preoperatively and only those who fulfil the selection criteria will be included in the study. The pulpotomy procedure will be performed on the 60 selected teeth which will be randomly divided into three groups according to the pulp dressing used.

Group 1 include 20 teeth which will be treated with Formocresol.

Group 2 include 20 teeth which will be treated with MTA.

Group 3 include 20 teeth which will be treated with Biodentine.

The procedure is as follows:

Following local anaesthetic administration and rubber dam application the caries will be removed and coronal access will be obtained with a no. 330 high speed bur to expose the pulp chamber. A spoon excavator will be used for coronal pulp amputation, and a moistened cotton pellet will be used to achieve haemostasis.

In group 1; A cotton pellet No. 4 will be moistened with Formocresol and after removing the excess it will be placed for 1 minute on the pulp stumps.

In group 2; The MTA will be manipulated by mixing 3 parts of powder with 1 part of liquid to obtain a putty consistency. This mix will be retrieved by plastic instrument and carried to the pulp chamber with an amalgam carrier and condensed lightly with a moistened cotton pellet.

In group 3; The Biodentine Capsule is opened and tapped gently on a hard surface to diffuse the powder. Five Drops of liquid from the single‐dose dispenser will be poured into the capsule, after which it is placed in a triturater for 30 seconds. The material is recovered with spatula and placed inside the cavity with an amalgam carrier using a cotton pellet material will be condensed without excessive pressure on pulp stumps

After the placement of medicament the teeth will be restored with Reinforced zinc oxide Eugenol paste followed by the placement of crown. Postoperative radiograph will be taken. The children will be recalled after two days to check for any discomfort.

The patient is recalled again for Clinical and radiographic evaluation after 3and 6 months using following criteria.

Clinical criteria19:

1.Pain


2. Percussion sensitivity

3. Swelling

4. Fistula

5. Pathologic tooth mobility

Radiographic criteria:

1. Radiolucency in periapical or furcation area

2. External or Internal resorption

3. Widening of periodontal space

4. Calcification of canal

The clinical and radiographic data for the 3 groups will be statistically analysed

by using the chi-square test.




REFERENCES

1. Peng L, Ye L, Guo X, Tan H, Zhou X, Wang C, Li R. Evaluation of formocresol versus ferric sulphate primary molar pulpotomy: a systematic review and meta-analysis. IntEndod J 2007;40:751-7.

2.Lewis B. Formaldehyde in dentistry: a review for the millennium. J ClinPediatr Dent 1998;22:167-77.

3.Eidelman E, Odont, Holan G, Fuks AB. Mineral trioxide aggregate vsformocresol in pulpotomized primary molars: A preliminary report. Pediatr Dent 2001;23:15-8.

4.Myers DR, Shoaf HK, Dirksen TR, Pashley DH, Whitford GM, Reynolds KE. Distribution of 14C-formaldehyde after pulpotomy with formocresol. J Am Dent Assoc 1978;96:805-13.

5.Ranly DM. Pulpotomy therapy in primary teeth: New modalities for old rationales. Pediatr Dent 1994;16:403-9

6.Caicedo R, Abbott PV, Alongi DJ, Alarcon MY. Clinical, radiographic and histologicalanalysis of the effects of mineral trioxide aggregate used in direct pulp capping and pulpotomies of primary teeth. Aust Dent J 2006; 51:297–305.

7. Holah G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent 2005;27:129-36.

8. Salako N, Joseph B, Ritwik P, Salonen J, John P, Junaid TA. Comparison of bioactive glass, mineral trioxide aggregate, ferric sulfate and formocresol as pulpotomy agents in rat molar. Dent Traumatol 2003;19:314-20.

9. Koh ET, Pittford TR, Torabinejad M, McDonald F. Mineral trioxide aggregate stimulates cytokine production in human osteoblasts. J Bone Min Res 1995;10S:S406.

10. Torabinejad M, Hong CU, McDonald F, Pitt Ford TR. Physical and chemical properties of a new root end filling materials. J Endod 1995;21:349-53.




11. Torabinejad M, Chivian N. Clinical applications of mineral trioxide aggregate. J Endod 1999;25:197-205.

12. Castellucci A. The use of mineral trioxide aggregate in clinical and surgical endodontics. Dent Today 2003;22:74-80.

13.Zanini M, Sautier JM, Berdal A, Simon S. Biodentine induces immortalized murine pulp cell differentiation into odontoblast-like cells and stimulates biomineralization. J Endod. 2012 Sep;38(9):1220-6.

14.Pérard M, Le Clerc J, Meary F, Pérez F, Tricot-Doleux S, Pellen-Mussi P. Spheroid model study comparing the biocompatibility of Biodentine and MTA. J Mater Sci Mater Med. 2013 Jun;24(6):1527-34.

15.Tran XV, Gorin C, Willig C, Baroukh B, Pellat B, Decup F et al. Effect of a calcium-silicate-based restorative cement on pulp repair.J Dent Res. 2012 Dec;91(12):1166-71.

16.Shayegan A, Jurysta C, Atash R, Petein M, Abbeele AV. Biodentine used as a pulp-capping agent in primary pig teeth. Pediatr Dent. 2012 Nov-Dec;34(7):e202-8.

17. About I, Laurent P, Tecles O. Bioactivity of BiodentineTM: a Ca3SiO5-­‐based Dentin Substitute. Oral session, IADR Congress 2010 July, Barcelona Spain

18. Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, KosierkiewiczA et al. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7.



19. Havale R, Anegundi RT, Indushekhar KR, Sudha P. Clinical and Radiographic Evaluation of Pulpotomies In Primary Molars With Formocresol, Glutaraldehyde and Ferric Sulphate. OHDM. 2013 March;12(1):24-31.



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