|Year : 2019 | Volume
| Issue : 2 | Page : 115-119
Is Biodentine, as successful as, mineral trioxide aggregate for pulpotomy of primary molars? A split-mouth clinical trial
Walid A Fouad, Randa Y Abd Al Gawad
Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Cairo, Egypt
|Date of Submission||02-Oct-2018|
|Date of Acceptance||15-Feb-2019|
|Date of Web Publication||23-Sep-2019|
Randa Y Abd Al Gawad
301 Venus, Royal City, Sheikh Zayed, Giza
Source of Support: None, Conflict of Interest: None
Despite the clinical and radiographic success of mineral trioxide aggregate (MTA) pulpotomy in primary molars, it does not gain much clinicians acceptance regarding manipulation difficulties.
This study aims to assess success rates of Biodentine and MTA used as pulpotomy agents in human primary molars, both clinically and radiographically.
Patients and methods
A split-mouth controlled clinical trial was carried out on 21 healthy, 3–7-year old children, with 42 pairs (84 molars) of contralateral mandibular primary molars indicated for pulpotomy. One paired tooth in one side was designated to Biodentine (group 1) and the other side for MTA (group 2) as a pulp medicament. All pulpotomized teeth were finally restored with stainless-steel crowns. Patients were monitored clinically and radiographically at 1, 3, 6, and 12 months.
For all the patients available for the follow up appointments, Biodentine and MTA showed 100% success rate both clinically and radiographically.
Biodentine and MTA are highly recommended as pulpotomy medicaments in primary molars.
Keywords: Biodentine, mineral trioxide aggregate, primary molars, pulpotomy
|How to cite this article:|
Fouad WA, Abd Al Gawad RY. Is Biodentine, as successful as, mineral trioxide aggregate for pulpotomy of primary molars? A split-mouth clinical trial. Tanta Dent J 2019;16:115-9
|How to cite this URL:|
Fouad WA, Abd Al Gawad RY. Is Biodentine, as successful as, mineral trioxide aggregate for pulpotomy of primary molars? A split-mouth clinical trial. Tanta Dent J [serial online] 2019 [cited 2019 Nov 17];16:115-9. Available from: http://www.tmj.eg.net/text.asp?2019/16/2/115/267564
| Introduction|| |
Deep carious lesions of primary molars without any signs or symptoms of extensive pulpal degeneration are treated using pulpotomy procedure. Pulpotomy is a treatment where the coronal pulp is amputated and the radicular healthy pulp is preserved within the root canals, followed by placement of a medicament and good coronal seal until natural exfoliation of the primary molars .
With the advent of newer biocompatible materials such as mineral trioxide aggregate (MTA), with proven success than the older agents, the future of this treatment modality appears very promising ,.
Despite its clinical and radiographic success over years and proven favorable histological response , MTA does not gain much clinicians acceptance regarding manipulation difficulties. MTA showed poor complicated handling characteristics, slow setting where it takes about 24 h to reach final setting; rendering the technique sensitive procedure, even more difficult and restricted its use to specialists .
Biodentine is a relatively new calcium silicate cement and dentine substitute which can be used for regenerative pulpotomy. It is very successful in the induction of reparative dentine formation. Biodentine overcomes the drawbacks of MTA; it shows accelerated setting due to the addition of setting accelerators, good handling characteristics and better cost effectiveness ,.
Thus, this study was conducted to assess the success rates of Biodentine and MTA, used as pulpotomy agents, in human primary molars both clinically and radiographically.
| Patients and Methods|| |
Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, Cairo University.
The present study was a split-mouth controlled clinical trial, where a sample size of 21 patients with 42 pairs of mandibular molars was included in the study.
The study population included 3–7-year old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University and had two matched bilateral deep carious mandibular primary molars indicated for pulpotomy which met specific inclusion and exclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure.
- No history of spontaneous pain
- Absence of tenderness to percussion
- Absence of physiologic or pathologic tooth mobility
- No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract
- Restorable teeth
- Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection).
- Evidence of necrosis after access cavity preparation
- Hemostasis could not be achieved within 3 min after direct contact with a wet cotton pellet, prior to material placement.
Matched molars in each pair were randomly designated using computer software (Random.org, Randomness and Integrity Ltd, Dublin, Ireland) to group 1: which received Biodentine (Septodont, Fossés, France), or group 2: which received MTA (Angelus, Londrina, Brazil), as pulp medicament.
Preoperative periapical radiograph using periapical film size two Speed D Film (Kodak, New York, New York, USA), was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis.
The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and de-roofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high-speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with physiologic saline. Pulp hemostasis was achieved using a sterile wet cotton pellet applied for 2–3 min.
In group 1: following the manufacturer's instructions, Biodentine capsule was gently tapped on a hard surface; five liquid drops were poured from the single dose dispenser into the capsule. The capsule was triturated for 30 s. Then the triturated mix was introduced into the pulp chamber using amalgam carrier and condensed properly against the pulp orifices; filling the entire pulp chamber.
In group 2: the MTA powder was mixed with sterile water in a 3: 1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.
Molars of both groups were finally restored with stainless-steel crowns (3M, St Paul, Minnesota, USA) cemented with GI cement (Ketac Cem; 3M). An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation
All treated patients were followed up at 1, 3, 6, and 12 months after the pulpotomy for clinical and radiographic evaluation. Independently, two examiners evaluated the teeth clinically and radiographically. The clinical examinations and radiographic interpretation were validated for the two examiners. The intraexaminer consistency was confirmed through repeated clinical examinations and radiographic interpretation for 10 cases and the interexaminer consistency performed between the two examiners. Calibration tested by Kappa test, the intraexaminer and interexaminer consistencies were 100 and 99%, respectively.
The pulpotomized teeth were judged as clinically successful if they met the following criteria: absence of sensitivity, pain, tenderness to percussion, abscess, fistula, or tooth mobility. Radiographic success was defined if there were normal periodontal ligament space, absence of furcation or periapical radiolucency, absence of internal or external root resorption ,.
Data were collected, revised for completeness and logical consistency, tabulated, and statistically analyzed. For the two groups, clinical and radiographic findings at 1, 3, 6, and 12 months postoperatively were assessed. Statistical analysis was performed with IBM, SPSS for Windows (version 23; IBM Corporation, New York, New York, USA).
| Results|| |
A total of 42 pairs, that is 84 molars in 21 children (11 boys and 10 girls) were treated in this trial. A Consort diagram showing the study protocol up to the 12 months follow-up was presented [Figure 1].
|Figure 1: A consort diagram showing the study protocol up to 12-month follow-up.|
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At the time of treatment, the patients' age ranged between 3–7 years with a mean age of 5.3 ± 0.81 years. Clinical calibration and radiographic interpretation of the results were found to be in excellent agreement by the two examiners.
All molars, in both groups, were clinically asymptomatic at 1, 3, 6, and 12 months follow ups without any sensitivity, pain, tenderness to percussion, abscess, fistulation, or tooth mobility [Table 1].
|Table 1: Clinical success rate for both groups during different follow up periods|
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Similarly, none of the treated molars showed internal resorption, external resorption, furcation radiolucency, or periapical radiolucency [Table 2], [Figure 2], [Figure 3].
|Table 2: Radiographic success rate for both groups during different follow up periods|
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|Figure 2: Periapical radiographs of group 1: (a) preoperative, (b) immediate postoperative, (c) 1-month postoperative, (d) 3-month postoperative, (e) 6-month postoperative, (f) 12-month postoperative.|
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|Figure 3: Periapical radiographs of group 2: (a) preoperative, (b) immediate postoperative, (c) 1-month postoperative, (d) 3-month postoperative, (e) 6-month postoperative, (f) 12-month postoperative.|
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| Discussion|| |
The present split-mouth controlled clinical trial is a prospective clinical study for vital pulpotomy in primary molars using Biodentine and MTA. Biodentine was chosen in the current study because it is a relatively new bioactive material with high regeneration power and excellent sealing ability. It is highly recommended in many clinical applications including pulp therapy ,. The largely improved physical properties made it much more user friendly with shorter setting time than that of MTA ,.
Nowadays MTA has proven highly successful in regenerative pulpotomy and has replaced FC as a pulpotomy agent, however it lacks clinicians' satisfaction due to difficulty of clinical manipulation and it is not easily resorbed ,; advantages offered by Biodentine ,.
Children between 3 and 7 years old were included in the present trial taking into consideration the lack of cooperation of younger children and physiologic root resorption in elder ones. The split-mouth technique was used in this study, for elimination of interpatient differences regarding age, sex, morphology, oral environmental conditions, and treatment response . Only mandibular molars were included in the present study because they show more accurate radiographic interpretation than maxillary ones.
Pulpotomy procedures were performed by the same operator to avoid individual variations between different operators. All pulpotomized teeth were finally restored with GI cement and stainless-steel crowns which represent the most effective long-term restoration for pulpotomized primary molars .
An immediate postoperative radiograph was obtained to document the quality of treatment and to help determine the prognosis. This image also would serve as a comparative baseline for future follow ups. Since failure of a primary molar pulpotomy may be evident in the furcation or periapical area, periapical radiographs which clearly demonstrated both the interradicular and the periradicular areas were used to monitor prognosis after treatment.
All pulpotomized teeth were followed up clinically and radiographically at 1, 3, 6, and 12 months according to AAPD recommendations .
The results of the present study, at all observation time points, showed 100% success rates both clinically and radiographically for both materials. These results were comparable to what were previously reported by Niranjani et al. , in a study to evaluate the efficacy of MTA, lasers, and Biodentine used as pulpotomy agents both clinically and radiographically. Among molars treated with lasers and Biodentine, pain, and swelling were observed in two molars, in each group, at the end of 6 months. Whereas among molars treated with MTA, no molar revealed abnormal findings, within the available sample for follow up, with no statistically significant difference between groups.
Similarly, Cuadros-Fernández et al. , reported high success rates clinically and radiographically by the 12 months. Clinically Biodentine and MTA reported 97 and 92% success rate, respectively, while radiographically Biodentine showed 95% success and MTA showed 97%.
Also, these results were in agreement with Rajasekharan et al. , who reported clinical success (radiographic success in parenthesis) of 95.24% (94.4%) and 100% (90.9%) for Biodentine and MTA, respectively, with nonsignificant difference between groups.
The high success rates observed in the present trial could be attributed to proper case selection, precise technical procedures in addition to the high biocompatibility, alkalinity, regeneration ability, and excellent sealing ability of the new regenerative materials ,,. Additionally, these results are explained on histologic basis by Shayegan et al. , who observed that Biodentine like MTA, promoted beneficial calcification in contact with vital pulp after pulpotomy and direct pulp capping in primary molars of pigs.
| Conclusion|| |
Based on this study results, we may conclude that both Biodentine and MTA demonstrate favorable treatment outcomes in pulpotomy of primary molars.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]