Irreversible Pulpitis Clinical Trial
Official title:
154/2013 Grant for Mineral Trioxide Aggregate and Biodentine for Vital Pulp Therapy
This study aimed to evaluate the clinical performance of White MTA (MTA, Angelus, Londrina,
Brazil) and Biodentine™ in pulp capping of cariously exposed mature permanent teeth.
The investigator performed a prospective longitudinal randomized controlled study utilizing
vital permanent mature teeth with deep caries. Patients will be divided randomly into
Biodentine™ and MTA groups; Teeth will be assessed clinically and radiographically prior to
the procedure. Caries will be excavated under local anesthesia, hemostasis is achieved after
pulp exposure using NaOCl and will be capped with Biodentine™ or MTA. Clinical and
radiographical follow-up will be performed by a blinded calibrated evaluator after six months
and one year, and yearly after.
Study design and ethical approval This prospective longitudinal, parallel-design, randomized
clinical trial was set up and is reported according to CONSORT statement. It assessed the
outcome of using Biodentine or MTA as a capping material in human mature permanent teeth.
Ethical approval for this study was obtained from the Institution Review Board (IRB number
(154/13). All participants provided written informed consent after the purpose and
methodology were explained in full.
Patient recruitment All patients visiting the Initial Treatment Unit and Post Graduate Dental
Clinics were screened for inclusion . Dental examinations were performed to determine whether
the patients fulfilled the needed criteria
Approximately 50 subjects will be needed for the study in order to elicit any significant
findings as demonstrated by a power analysis from a similar study. The patients will be
divided into two groups based on the capping material used. Biodentine™ (Septodont, St.
Maur-des-Fossés, France) group, and MTA reparative cement (Angelus, Londrina, Brazil) group.
Teeth will be randomly assigned to either group with a coin toss. This included patients with
a single offending tooth; the following patient will be then assigned to the other group to
keep sample sizes equal in both groups. Patients with more than one offending tooth will have
one tooth treated with Biodentine and the other with MTA using again coin toss to randomly
distribute capping material among offending teeth.
Clinical examination Pre-operative clinical examinations included a visual inspection of the
extent of caries, gingival health, and adjacent soft tissue. A percussion test will be
performed, and the periodontal status will be assessed. Pulpal sensibility will also be
assessed by cold test with Endo Ice F (Colten-Whaledent, Germany). Patients reporting sharp
pain to cold test that did not linger were diagnosed with reversible pulpitis. Patients
reporting severe lingering or spontaneous pain were diagnosed with irreversible pulpitis.
Periapical and bitewing radiographs will be obtained for each offending tooth to assess the
extent and location of caries, proximity of caries to the pulp, restorability of each tooth,
periapical status, and presence of intra-radicular pathosis. Radiographs will be taken using
a parallel technique and will be viewed by the naked eye using a viewing box with uniform
bright light in a darkened room. All data will be collected by one examiner to ensure
reliability.
Clinical protocol Profound local anesthesia of each tooth will achieved by standard
infiltration or inferior dental block injection with lidocaine and epinephrine (1:100000)
(Xylestesin-A 3M ESPE, Seefeld, Germany). Then, the tooth will be isolated with a rubber dam.
The clinical crown disinfected with a cotton pellet soaked in chlorhexidine. Caries will be
excavated using a round, high-speed diamond bur with adequate water cooling followed by a
round carbide bur. Every attempt will be carried to remove all carious tissue before exposing
the pulp. A cotton pellet moistened with 5% NaOCl to be placed into the cavity before pulpal
exposure. The size of the pellet varied according to the size of remaining caries; The
moistened cotton pellet was left in place for 1-5 minutes to achieve hemostasis. Sodium
hypochlorite-soaked cotton will be used to control bleeding in this study.
Once bleeding stopped, capping material will be placed over the exposed pulp. Failure to stop
bleeding within additional 3 minutes indicated incomplete removal of the inflamed pulp. In
these cases, partial or complete pulpotomy will be performed before capping. Failure to
control bleeding after a full pulpotomy indicated propagation of the inflammation to the
radicular pulp.
Biodentine™ will be prepared according to the manufacturer's instructions and used to fill
half the cavity. Biodentine™ should set within 12 minutes according to the manufacturer. MTA
reparative cement will be prepared at a powder:liquid ratio of 3:1 using distilled water
according to manufacturer's instructions . MTA to be applied to exposed pulp tissue and
adjacent dentine at a thickness of 1.5 to 3 mm. The final restoration will be a resin
composite (Z250, 3M, ESPE, USA). Patients are asked to contact the operator if they
experience any pain. The first review appointment to be scheduled a week after capping
procedure. The patient will be questioned about sensitivity, mastication discomfort, and
sensations of pain.
Recall protocol Six-month and yearly after follow-up appointments will be scheduled.
Patients, who are not aware of the type of capping material received, will be questioned
about pain, sensitivity, and mastication discomfort. Clinical examinations to be performed to
detect soft tissue swelling, sinus tract, the integrity of the coronal restoration, and tooth
mobility. The review visits to be performed blindly by another operator. Radiographical
examinations will also be performed to evaluate the periapical status, the formation of the
dentine bridge, pulpal calcifications, or canal obliteration and evidence of tooth
discoloration. Tooth vitality will be monitored by cold tests. Treatment was considered
successful based on the following features: absence of severe spontaneous pain, no discomfort
while eating, no soft tissue swelling, mobility that is no greater than grade I, the absence
of periapical rarefaction, internal or external resorption, root canal obliteration, and
normal viability following pulpotomy.
Statistical analysis The data will be processed using the JMP software (SAS Institute Inc.,
North Carolina, United States) with alpha=0.05. The chi-square test (significance level of <
0.05) will be used to determine differences between the success rates of Biodentine and MTA.
The survival probabilities will be compared using The Wilcoxon and the log-rank tests.
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