TITLE : COMPARATIVE EVALUATION OF PLATELET RICH FIBRIN, PROPOLIS AND MINERAL TRIOXIDE AGGREGATE AS PULPOTOMY AGENTS IN PRIMARY MOLARS:­A RANDOMIZED CONTROLLED TRIAL

INTRODUCTION:

The pulp of primary teeth that have suffered caries or trauma must be preserved in order to retain the integrity of the dental arches and to maintain aesthetics before the eruption of the permanent successors. The method chosen for vital pulp therapy depends on extend of pulpal inflammation, when just the coronal pulp is inflamed due to bacterial penetration after carious, traumatic, or iatrogenic reasons and the radicular pulp is not inflamed, a pulpotomy is the preferable treatment.

One of the most popular treatments for cariously exposed pulp in primary molar teeth is pulpotomies. For vital primary teeth, there are two treatment options: pulpotomy and indirect pulp treatment (IPT).¹ The indications for IPT and pulpotomy are the same. The difference lies with the caries removal process. IPT purposely avoids an exposure by leaving the residual deepest decay in place while pulpotomy is undertaken when a pulp exposure has occurred.² Pulpotomy treatment is classified according to three objectives: devitalisation, preservation and regeneration.³ Inspite of the safety concerns, formocresol (FC) is considered to be an acceptable dressing agent by the American Academy of Paediatric Dentistry for use in pulpotomy procedures and is still taught in many dental schools.⁴ The current trend is to use a regenerative procedure and reduce the incidence of the devitalisation procedure. Due to toxic effect and evidence of causing potential carcinogenicity, the use of formocresol have been raised many questions among dentist. Additionally, the constituent of formocersol, formaldehyde (mutagen and carcinogen) and cresol (caustic agent) also raised concern among dentists. use of Recent materials which have shown significant potential for regeneration are Platelet Rich Fibrin, Propolis and mineral trioxide aggregate (MTA)

MTA has been approved by the Food and Drug Administration of the USA since 1998. MTA is a powder composed of tricalcium silicate, bismuth oxide, dicalcium silicate, tricalcium aluminate, tetracalcium aluminoferrite, and calcium sulfate dihydrate. Shortcomings of MTA have led to the development of a new materials. Barriers like high cost of this material and the complexity of its handling have limited its use as a common material.⁵

Nowadays, use of natural plant products for therapeutic purposes, the phytotherapy, is gaining popularity. Propolis is a bee hive product that honey bees produce from the substances gathered from tree buds, leaf buds, and plant resinous secretions. It has potent antibacterial, anti-inflammatory, and tissue-regenerative properties.  Propolis is also used as an intracanal irrigant and wound healing material. It has also demonstrated promising results as a vital pulp therapy agent in animal teeth (Parolia et al., 2010).⁶

Platelet rich fibrin was first used in 2001 by Choukroun et al.⁷, specifically in oral and maxillofacial surgery, and is currently considered as a new generation of platelet concentrate. It consists of a matrix of autologous fibrin⁸ and has several advantages over PRP, including easier preparation and not requiring chemical manipulation of the blood, which makes it strictly an autologous preparation.⁹  PRF consists of an autologous leukocyte-platelet-rich fibrin matrix,¹⁰ composed of a tetra molecular structure, with cytokines, platelets, cytokines, and stem cells within it, which acts as a biodegradable scaffold that favours the development of micro vascularization and is able to guide epithelial cell migration to its surface.^11–13 Also, PRF may serve as a vehicle in carrying cells involved in tissue regeneration and seems to have a sustained release of growth factors in a period between 1 and 4 weeks, stimulating the environment for wound healing in a significant amount of time.¹⁴ Hence, PRF can be good alternative pulpotomy agent for primary teeth.

Very few literatures were found regarding comparison of Platelet Rich Fibrin, Propolis and Mineral Trioxide Aggregate as pulpotomy agents. Therefore, this current study is designed to compare the clinical and the radiographic success of Platelet Rich Fibrin, Propolis and Mineral Trioxide Aggregate as pulpotomy agents in primary molars with the null hypothesis that they would show no difference in clinical and radiographic success.

Primary Research Question :Which among Platelet Rich Fibrin, Propolis and Mineral Trioxide Aggregate is a better pulpotomy agent clinically and radiographically in primary molars?

Secondary Research Question : What is the effect of Platelet Rich Fibrin, Propolis and Mineral Trioxide Aggregate as pulpotomy agent in primary molars?

Primary Hypothesis  :Platelet Rich Fibrin and Propolis are better pulpotomy agents in primary molar as compared to Mineral Trioxide Aggregate

Other Hypothesis 1: Platelet Rich Fibrin and Propolis are not better pulpotomy agent in primary molar as compared to Mineral Trioxide Aggregate.

Primary objective: - To compare and evaluate clinically and radiographically primary molar teeth treated with Platelet Rich Fibrin, Propolis and Mineral Trioxide Aggregate as pulpotomy agents.

Other objectives 1: Evaluation of clinical and radiographic findings of primary molar teeth treated with Platelet Rich Fibrin.

Other objectives 2: Evaluation of clinical and radiographic findings of primary molar teeth treated with Propolis.

Other objectives 3 : Evaluation of clinical and radiographic findings of primary molar teeth treated with Mineral Trioxide Aggregate.

Methodology:

·     Study Population:  The clinical procedure and associated risk and benefits will be explained to the parents or legal guardian of the participant. Written inform consent will be obtained from the parents or legal guardian of the participants. All participants will be screened by taking a detailed history and performing a thorough clinical and radiographical examination. Healthy patient between 4-9 years of age with sixty (60) carious primary molars which could be restored and history of spontaneous pain will be included in the study.  Ethical clearance to conduct the study will be obtained from the institution.

·       Methods of Data Collection- After obtaining appropriate permissions from the Department of Pediatric and Preventive dentistry and Institutional Ethical Committee, data collection procedure will be carried out.

Sample size is calculated by taking reference from article of bernard rosner( 5^th edition) based on equation 8.27

The selected teeth will be randomly

Group A : Platelet rich fibrin

Group B: Propolis

Group C: Mineral trioxide aggregate

Inclusion Criteria

·       Healthy patient between the age of 4-9 years of age

·       Exposure of vital pulp due to dental caries, approxi­mating to the pulp radiographically.

·       Teeth should be restorable after completion of the procedure.

·       At least two-third of remaining root length.

Exclusion Criteria –

·       Patient with draining sinus.                                                                                                               

·       Pathological mobility.                                                                                                                                                                                                                                                                                

·       History of unprovoked tooth ache/persistent tooth ache.                                         

·       Highly viscous, sluggish, absent haemorrhage observed at radicular.

·       Periapical radiolucency.                                                                                    

·       Dystrophic calcification.                                                                                                                 

·       Interradicular bone loss.                                                                                                                                                     

·       Exfoliating tooth.                      

·       Presence of symptoms indicative of advanced pulpal inflammation, such as spontaneous pain or history of nocturnal pain.

For randomization simple random sampling using randomization software will be done. Selection of Subjects Study will carry out on 60 carious primary molars selected from children aged between 4-9years. A single-blinded clinical trial will be conducted to evaluate and compare the clinical and radiographic success of pulpotomy of primary molars performed with platelet rich fibrin, Propolis and mineral trioxide aggregate. Primary molars selected in this study will be based on clinical and radiographical screening. For each of the selected tooth, topical & local anaesthesia will be applied. Subjective and objective symptoms for successful effectiveness anaesthesia will be assessed. After achieving it, isolation will obtain using rubber dam application. All the peripheral infected caries will be removed and pulp chamber will be deroofed using diamond bur followed by irrigation to remove dentinal debris. Coronal pulp amputation will be achieved with small and medium slow-speed round burs (sterile), thereby taking adequate care to avoid cutting the pulp chamber floor. The remaining pulp tissue will be excavated with sterile spoon excavators and the chamber will be irrigated with saline. Haemorrhage will be control by applying pressure with wet sterile cotton pellets. On achieving haemostasis, the radicular pulp will assess and tooth will be considered for pulpotomy only if bleeding will arrest naturally.

·       ARMAMENTARIUM AND MATERIALS

1.     Local anaesthetic agent

2.     Round bur

3.     Cotton

4.     Spoon excavator

5.     Airoter

6.     Rubber dam

7.     Mouth mask

8.     Syringe

9.     Mouth mirror

10.  Tweezer

11.  Centrifugal machine

12.  Zinc oxide eugenol

13.  Glass ionomer cement

14.  Pulpotomy material

After complete removal of the coronal pulp and obtaining the haemostasis, the MTA paste will be obtained by mixing 3 parts of powder with 1 part of water to obtain a putty like consistency. This mix will then carry with the MTA carrier and placed in the pulp chamber and condensed lightly with a moistened cotton pellet. This will be followed by placement of a layer of zinc oxide eugenol (ZOE) thick mix. In the next appointment, temporary dressing of ZOE will be replaced with glass ionomer cement. The children will be recalled

at 3-,6- and 9-months interval for clinical and radiographical evaluation.

The postoperative clinical and radiographic success will be evaluated by the criteria enumerated  as follows:

Clinical score:

1: Asymptomatic-Pathology,mobility

2.Slight discomfort- percussion, gingival inflammation, mobility

3.Minor Discomfort- Pathology, Gingival swelling

4.Major Discomfort- Gingival swelling, periodontal pocket formation(exudate)

Radiographic score:

1.     No changes present at 3,6and 9-month follow up ( Internal root canal form tapering from chamber to the apex)

2.     Pathological changes of questionable clinical significance at 3-month follow-up ( External changes are not allowed (widened PDL) widening, abnormal inter-radicular trabeculation or variation in radiodensity, Internal resorption   acceptable (not perforated) Calcific metamorphosis is acceptable and defined as: uniformly thin root canal; shape (non-tapering); variation in radiodensity from canal to canal (one cloudier than the other)

3.     Pathological changes present at 3 months of follow up (Mildly widened PDL,  minor interradicular radiolucency with trabeculation still present, Minor external root resorption; internal resorption changes are acceptable, but not if external change is also present (perforated form)

4.     Pathological changes present extract immediately ( frank osseous radiolucency present)

            Statistical analysis: Statistical analysis will be done with Statistical Package for Social Sciences (IBM SPSS Statistic for window, version 21.0. Armonk, NY: IBM Corp.) at 95% CI and 80% power to the study.

Descriptive statistics will be performed in terms of mean, standard deviation and frequency and percentage.

Pearson’s chi square test will be applied to check statistical significance.

Statistical significance will be calculated at p<0.05.

References:

 1.        Simancas-Pallares MA, Díaz-Caballero AJ, Luna-Ricardo LM. Mineral trioxide aggregate in primary teeth pulpotomy. A systematic literature review. Med Oral Patol Oral Cirugia Bucal. 2010 Nov 1;15(6):e942-946.

2.         Vidya KB, Patil SB, Anegundi RT. Is pulpotomy obsolete? A clinical study on the success rates of indirect pulp capping and pulpotomy in the treatment of deep dentinal caries in primary second molars. J Int Clin Dent Res Organ. 2015 Jan 1;7(1):24.

3.         Shabzendedar M, Mazhari F, Alami M, Talebi M. Sodium hypochlorite vs formocresol as pulpotomy medicaments in primary molars: 1-year follow-up. Pediatr Dent. 2013;35(4):329–32.

4.         Marghalani AA, Omar S, Chen JW. Clinical and radiographic success of mineral trioxide aggregate compared with formocresol as a pulpotomy treatment in primary molars: a systematic review and meta-analysis. J Am Dent Assoc 1939. 2014 Jul;145(7):714–21.

5.         Parirokh M, Torabinejad M. Mineral trioxide aggregate: a comprehensive literature review--Part I: chemical, physical, and antibacterial properties. J Endod. 2010 Jan;36(1):16–27.

6.         Parolia A, Thomas MS, Kundabala M, Mohan M. Propolis and its potential uses in oral health. Int J Med Med Sci. 2010;2(7):210–5.

7.         Salgado-Peralvo AO, Garcia-Sanchez A, Wehbe A, Garrido N, Ortega E. Uso del plasma rico en plaquetas y leucocitos (L-PRF) en Implantología Oral. 2018.