|Year : 2021 | Volume
| Issue : 6 | Page : 606-610
|Comparative assessment of titanium-prepared platelet-rich fibrin, EndoSequence root repair material, and calcium hydroxide as pulpotomy agents in permanent teeth with irreversible pulpitis: A randomized controlled trial
Suryasowjanya Doranala1, Jayaprada Reddy Surakanti2, Harikumar Vemisetty2, Suraj Reddy Loka3, Keerthi Sudireddy4, Rajani Punna2
1 Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Hyderabad, Telangana, India
2 Department of Conservative Dentistry and Endodontics, Kamineni Institute Dental Sciences, Hyderabad, Telangana, India
3 Department of Public Health Dentistry, Government Dental College and Hospital, Hyderabad, Telangana, India
4 Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Manipal, Karnataka, India
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|Date of Submission||19-May-2021|
|Date of Decision||03-Dec-2021|
|Date of Acceptance||21-Dec-2021|
|Date of Web Publication||01-Apr-2022|
| Abstract|| |
Context: Pulpotomy is a procedure in which part of an exposed vital pulp is removed, usually as a means of preserving the vitality and function of the remaining part.
Aim: The aim is to compare the effectiveness of Dycal (CH), EndoSequence, and Titanium-prepared platelet-rich fibrin with EndoSequence (T-PRF) as pulpotomy agents in mature permanent molars with irreversible pulpitis.
Settings and Design: Sixty permanent mandibular molars with carious exposure and symptoms of irreversible pulpitis were randomly allocated to three groups.
Subjects and Methods: Full pulpotomy was performed using Dycal, EndoSequence, and T-PRF with EndoSequence as pulpotomy agents. Pain intensity was analyzed using a Numeric Rating Scale score at baseline 24 h, 7 days, 6 months, and 1 year. The clinical and radiographic evaluations were done at 6 months and 1 year.
Statistical Analysis: Nonparametric tests (Kruskal–Wallis, Chi-square) were applied to analyze the data as the normality test does not follow a normal distribution.
Results: T-PRF and EndoSequence showed effective results when compared clinically, and there was no significant difference between radiographic success rates among the three groups at (P = 0.325 at 6 months, 0.466 at 12 months) follow-up.
Conclusion: T-PRF and EndoSequence showed higher success rates among Dycal, EndoSequence as pulpotomy agents in teeth with irreversible pulpitis.
Keywords: Dycal; Irreversible pulpitis; pulpotomy; titanium-prepared platelet-rich fibrin
|How to cite this article:|
Doranala S, Surakanti JR, Vemisetty H, Loka SR, Sudireddy K, Punna R. Comparative assessment of titanium-prepared platelet-rich fibrin, EndoSequence root repair material, and calcium hydroxide as pulpotomy agents in permanent teeth with irreversible pulpitis: A randomized controlled trial. J Conserv Dent 2021;24:606-10
|How to cite this URL:|
Doranala S, Surakanti JR, Vemisetty H, Loka SR, Sudireddy K, Punna R. Comparative assessment of titanium-prepared platelet-rich fibrin, EndoSequence root repair material, and calcium hydroxide as pulpotomy agents in permanent teeth with irreversible pulpitis: A randomized controlled trial. J Conserv Dent [serial online] 2021 [cited 2023 Jun 1];24:606-10. Available from: https://www.jcd.org.in/text.asp?2021/24/6/606/342472
| Introduction|| |
An advanced treatment shift in endodontics aiming toward tissue preservation and regeneration has been evolved with a better understanding of biological mechanisms with pulpotomy.
The rationale of preserving the vital pulp is to maintain the vitality of pulp tissue by eradicating bacteria from the dentin-pulp complex. The choice of pulpotomy agent is a key that impacts the success rate of this technique.,,,
As per our knowledge, this is the first clinical trial designed to compare the clinical and radiographic success outcome of titanium-prepared platelet-rich fibrin (T-PRF) with EndoSequence, EndoSequence, and Dycal as pulpotomy agents in human permanent teeth affected by irreversible pulpitis.
| Subjects and Methods|| |
It is a prospective double-blinded randomized controlled trial. Ethical approval for the study was obtained from the institutional review board (IEC Number KIIDS/IEC/2017/21).
The specific goal is to assess postoperative pain clinically and long-term success rates utilizing radiographic analysis with various pulpotomy agents at regular intervals.
- Patients aged 15–55 years with a noncontributory medical history
- Deep caries with subsequent pulp exposure in a permanent molar tooth
- The tooth should respond to pulp vitality tests
- Pulp tissue bleeding should be present in all canals after complete pulpotomy
- Teeth with symptomatic irreversible pulpitis without periapical rarefaction
- Teeth should be restorable
- Hemostasis should be achieved after complete pulpotomy.
- Deciduous teeth and teeth with deformities, cracks, fractures and restorations, active disease, severe/moderate periodontal disease, root resorption, root canal calcification, and associated abscess.
Sixty volunteers fulfilling the inclusion criteria were recruited into the study. Participants were selected from the pool of patients reporting to the Department of Conservative Dentistry and Endodontics. Block randomization procedure was chosen for randomization. Sequentially, numbered, opaque, and sealed envelope method was implemented for randomization. Double blinding is done because the patient and evaluator do not know the type of intervention being used according to the CONSORT checklist.
Patients with occlusal caries encompassing permanent mandibular molar teeth with complete root development and symptoms of irreversible pulpitis were included in the study. Informed consent was obtained from all the patients. Patients were divided into three study groups using the simple randomization method.
The entire endodontic procedure was carried out by a single operator in all the participants. After administering an inferior alveolar nerve block with 2% lignocaine containing 1: 80,000 adrenaline, the tooth was isolated with a rubber dam, caries removed with a sterile round diamond bur using a high-speed handpiece, an access cavity was prepared. The coronal pulp was excised up to the level of orifices with sterile round diamond bur and copious irrigation was performed. Sterile saline solution was used to irrigate the pulp to arrest bleeding. Depending on the pulpotomy agent used, the teeth were divided into three groups as follows:
Group 1: Calcium hydroxide (Dycal; ApaCal ART, Brussels, Belgium) Group: Light cure Dycal of 2 mm thick layer was placed over the exposed pulp tissue. The tooth was temporarily restored with Cavit (Jammu, India).
Group 2: EndoSequence (Brasseler USA, Savannah, GA) Group: EndoSequence was placed approximately 2 mm thick layer was placed over the exposed pulp tissue. A moist cotton pellet was placed over it, and the tooth was restored temporarily [Figure 1].
|Figure 1: CONSORT flow diagram. (a) preoperative radiograph. (b) placement of EndoSequence. (c) postoperative radiograph. (d) 12-month follow-up|
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Group 3: T-PRF and EndoSequence Group: T-PRF preparation was started at the time of starting caries excavation. Choukroun's technique with titanium tubes (CCMB, Hyderabad, India) was followed for the preparation of PRF. The pulpal wound was covered with a small piece of T-PRF and covered with an approximately 2 mm thick layer of EndoSequence. A moist cotton pellet was placed over it, and the tooth was restored temporarily [Figure 2].
|Figure 2: (a) Preoperative radiograph. (b) placement of titanium-prepared platelet-rich fibrin with EndoSequence. (c) postoperative radiograph. (d) 2-month follow-up|
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In all cases, the Cavit was replaced with glass-ionomer cement (Jammu, India) and composite (Ivoclar Vivadent, Amherst, NY, USA) after 7 days. Follow-up was conducted at 1-day, 1-week, 6-month, and then 12-month postoperatively. The primary (short term) outcome was determined by the pain-relief achieved using the Visual Analog Scale (VAS) postoperatively for 7 days. The secondary outcome was determined using the long-term (1 year) clinical and radiographic measures.
On completion of pulpotomy, pain assessment of all participants was carried out using VAS with ratings between 0 and 9. The patients had clinical and radiographic evaluation after 3-month, 6-month, and 1-year postoperatively.
The procedure was considered clinically successful if there was no history of spontaneous pain or discomfort during follow-up and radiographically successful if there was a periapical index <3 according to Østravik et al.
Nonparametric tests (Kruskal–Wallis, Chi-square) were applied to analyze as the data does not follow a normal distribution.
| Results|| |
Sixty patients were initially allocated. Two patients showed immediate failure because of excessive bleeding in the pulp chamber. Fifty-eight patients were included in the study [Flowchart 1]. The three groups did not have any significant difference in age, gender, tooth type, or preoperative mean intensity of the pain (P > 0.05) [Table 1]. The mean VAS scores were recorded pre and posttreatment among the study participants in groups which were calculated as clinical success rate. T-PRF and EndoSequence showed the maximum reduction of pain mean score (0.22 ± 0.39) at 12 months. The highest clinical success rate was calculated using VAS score among different intervals across three groups was noted at 24 h (98.3%). At intervals, there is a gradual reduction of pain at 7 days (95.0%), followed by 6 months (80.0%), 1 year (70.0%), and no statistically significant difference was observed between radiographic outcomes of three tested groups using Ørstawik criteria among 6 and 12-month interval [Table 2].
|Table 2: Clinical, radiographic, and overall success rates among different groups (Chi-square test)|
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| Discussion|| |
Pulpotomy in permanent teeth is a domain of interest in endodontics, with a view of understanding pulp biology better and developing bioactive materials. The present study was conducted following Good Clinical Practice guidelines to assess the clinical and radiographic outcome of pulpotomy using bioactive agents, i.e., Dycal, EndoSequence, and T-PRF with EndoSequence.
The mean age of patients is 25 years in the present study [Table 1]. A younger dental pulp is more cellular and has a better potential for healing and regeneration after removing the infected pulp tissue. However, a study conducted by Kunert et al. found that age was not a risk factor for vital pulp therapy (VPT). Furthermore, studies that included up to 50 years old reported high success rates of VPT,,12],, suggesting that VPT could work successfully in the elderly as in young patients.
Only mandibular molars were used in the study, removing the possibility of tooth type being a confounding factor. Full coronal pulpotomy was selected as it is a standardized procedure. The ability to control bleeding after amputation of the inflammatory area of the pulp has been proposed as a key prognostic factor, as well as a better indication of the degree of pulp inflammation than preoperative symptoms. Studies,, showed the “time to stop bleeding” parameter as a cutoff point to differentiate between the reversible and irreversible condition of the pulp. The bleeding criteria have been standardized as 5–10 min. However, the ability to control bleeding eventually by the use of bioactive materials and adequate coronal seal contributes to the high success rate.
The literature suggested various methods to control pulpal hemorrhage, including rinsing the surgical wound with sodium hypochlorite solution, physiologic saline solution, or hydrogen peroxide or pressing with a cotton pellet. In this study, physiological saline was used to stop the bleeding.
The choice of a pulpotomy agent is an essential decisive factor that can impact the success rate of this technique. It has been suggested that the healing of the dental pulp was not signiﬁcantly affected by the type of medicament but rather on the ability of the material to prevent microleakage.
Calcium hydroxide has been the most commonly utilized pulpotomy agent. In the present study, Dycal was used as the conventional pulp capping material and as a keystone for comparison. The reason for selecting Dycal instead of Ca (OH)2 lies in the fact that Dycal, with its lower pH, helps in preventing major tissue damage and stimulate reparative dentin more directly.
Another group, EndoSequence (EndoSequence root repair material) is composed calcium silicates, monobasic calcium phosphate, zirconium oxide, tantalum oxide, proprietary fillers, and thickening agents. It has nanosphere particles supplied in a putty form with a maximum diameter of 1 × 10 μm that allows for the material to enter dentinal tubules, which get moistened by dentin liquid and create a mechanical bond upon setting. This material is bioactive due to its capacity to produce hydroxyapatite or apatite-like layer on its surface when exposed to phosphate-containing fluids. It claimed to bond adjacent dentin with no shrinkage and to be highly biocompatible, hydrophilic, radiopaque, and antibacterial.
Based on biologically-based therapy, T-PRF was selected as a pulpotomy agent along with EndoSequence. T-PRF has better hemocompatibility of titanium compared to glass, which led to the formation of a more polymerized fibrin and more effective at activating platelets than glass tubes.
Massler exemplified that the most important cause of failure is bacterial recontamination during the healing process. Hence, a good coronal seal is the most important factor. A two-layered restoration consisting of GIC (3M ESPE Ketac Molar) ensured a good seal with minimal marginal leakage, followed by composite provided compressive and tensile strength and resistance to dissolution to clinch an effective seal.
According to meta-analysis, 3-month follow-up was adequate for tentative prognosis and a study by Zanini et al. stated that follow-up of 6 months seems to be appropriate for tentatively assessing the success of pulpotomy. A study by Kumar et al. performed a pulpotomy procedure for 12 months exhibited a high clinical success rate. Therefore, the present study has been standardized to 12-month follow-up to assess success.
The present study showed no statistically significant difference (P = 0.550) between clinical and radiographic outcomes in the three groups with an overall good clinical success rate of 76% at 12 months [Table 2]. As clinical success rate (76%) was much higher than the radiographic success rate (70%).
| Conclusion|| |
By preserving pulp vitality, the present clinical study showed VPT agents are effective for treating human permanent teeth with irreversible pulpitis, relieving associated pulpal symptoms.
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Conflicts of interest
There are no conflicts of interest.
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Dr. Suryasowjanya Doranala
1-9-1113/19/B, Vidyanagar, Dayandnagar, Hyderabad, Telangana
Source of Support: None, Conflict of Interest: None
[Figure 1], [Figure 2]
[Table 1], [Table 2]
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