Comparative evaluation of calcium silicate-doped treated dentin matrix and mineral trioxide aggregate as miniature pulpotomy biomaterials in deep carious lesions: a parallel, double-blind, randomized clinical trial

SUMMARY OF THE STUDY

Comparative evaluation of calcium silicate-doped treated dentin matrix and

mineral trioxide aggregate as a novel miniature pulpotomy biomaterials in

deep carious lesions: a parallel, double-blind, randomized clinical trial

Rationale of the study:

Vital pulp therapies have become common in recent years in part due to the

development of highly biocompatible materials like MTA and various

formulations of calcium silicate based materials. Calcium hydroxide based pulp

therapies have nearly been replaced by MTA. MTA and calcium silicates are

now recognized as the benchmark for vital pulp therapies.

Recently, Treated dentin matrix, an extracellular matrix-based biomaterial, has

emerged as an excellent scaffold for tissue engineering because of its

remarkable biological induction activity, distinct natural structure, and

biocompatibility. In addition to having a high level of bioactivity, a treated

dentin matrix can work as a transporter for bioactive substances and medication

molecules, aiding in the processes of tissue regeneration and

immunomodulation. Similar products such as demineralized bone matrices

(DBMs) and other allograft bone materials have already found their place in

clinical practice.

AIM:

To develop a Novel calcium silicate-doped human-treated dentin matrix

(CaSi+hTDM)to assess its potential as a Miniature Pulpotomy (MP)

biomaterial.

OBJECTIVES:

Primary objective:

To evaluate the efficacy of calcium silicate-doped human-treated dentin matrix

(CaSi+hTDM)compared to Mineral Trioxide Aggregate (MTA) in maintainingpulp vitality using cold testing following Miniature Pulpotomy (MP) in deep

and extremely deep carious lesions with reversible pulpitis

Secondary objectives:

1. To evaluate patient-reported outcomes such as pain, swelling, sinus tract etc.

post-operatively.

2. To determine the clinical success rates of both materials by assessing the

Periapical index of healing over a 1-year follow-up period.

Type of study: Randomized controlled trial

Duration of study: 18 months

Sample size:

According to the study by Bogen et al the success rate for Direct pulp capping

using MTA was 98%. Given the lack of specific evidence on the success rate

for Direct Pulp Capping (DPC) using calcium silicate-doped human-treated

dentin matrix (CaSi+hTDM) and since Miniature pulpotomy is a modification

of DPC, it was assumed that the success rate for CaSi+hTDM would not be

lower than that of MTA. Using a 20% non-inferiority limit, 80% precision of

the test, and 5% type I error rate, the required sample size was calculated to be

44 teeth per material group. To account for potential dropouts, 20% was added

to the required sample size, resulting in a final sample size of 98 teeth.

Inclusion criteria

• Patient age 14 -35 years.

• Noncontributory medical history (ASA1 and 2)

• Deep and extremely deep caries

• Vital mature teeth with symptoms of reversible pulpitis.

• Positive response to pulp sensibility testing.

• Clinical diagnosis of reversible pulpitis with PAI score less than or equal to 2.

• Tooth should be restorable

• Pocket depth and mobility should be within normal limits. (less than 4mm)

Exclusion criteria:

• Immature roots

• Clinical signs of pulp necrosis such as swelling or presence of sinus tract

• Prominent radiolucency in the furcation area, presence of internal or

external root resorption, any calcification, and any periapical lesion. No evidence of bleeding after exposure.

• Profuse hemorrhage from exposure site. (greater than 10minutes)

• History of spontaneous unprovoked pain, pain on percussion

• Presence of serous or purulent exudates from exposure site.

Fabrication of Calcium silicate doped-human treated dentin matrix (CaSi +

hTDM):

Human molars will be removed from patients for clinical reasons under ethical

approval. Periodontal and dental pulp tissue and enamel will be completely stripped

away to obtain dentin. The resulting dentin matrix will then be perforated and soaked

in deionized water for 5 hours and mechanically cleaned for 20 minutes every hour

using an ultrasonic cleaner. Human dentin matrices are then soaked in 17% Ethylene

Diamine Tetra-acetic Acid (EDTA) for 5 mins, washed in deionized water for 10 mins

in an ultrasonic cleaner, exposed to 10% EDTA for 5 mins, and washed in deionized

water for 10 mins in an ultrasonic cleaner, exposed to 5% EDTA for 10 mins, washed

in deionized water for 10 mins in an ultrasonic cleaner. To eliminate organic content,

teeth will be immersed in isopropanol for 2 hours. Samples will be stored in saline

solution in a refrigerator until milling is done to get a fine powder. A homogenizer will

be used for 5 mins at 1440 RPM.

Treatment procedure:

After Local anaesthesia administration, rubber dam isolation is done, the operative field

and the tooth will be disinfected using 5% sodium hypochlorite (NaOCl) prior to caries

excavation. A round diamond bur will be employed, along with a spoon excavator, to

thoroughly remove the soft caries under magnification. To confirm the intra-operative

pulp vitality, the presence of bleeding at the exposed pulp will be confirmed. Removal

of pulp tissue not exceeding 1 mm in depth. Haemostasis will be achieved by the

application of a pellet moistened with 2.5% NaOCl for 1 min with a dry pellet on topand repeated if required for up to 5 min. After controlling the bleeding, MTA or CaSi

doped hTDM will be applied over the pulp.

The post treatment clinical evaluation will be performed at 24, 48 and 72 hours, 3, 6

and 12 months.

Radiographic evaluation will be done at 3, 6,12 months.

Statistical Analysis:

The data will be entered in Epidata Manager v.4.4.6.0.6 [Odense, Denmark]. The data

will be cleaned and analysed using Epi Analysis. We will check the normality of the

data using Shapiro Wilk and Kolmogorov Smirnov test. Depending on the normality

continuous data will be described as mean ± standard deviation (± SD) or median and

interquartile range where appropriate. For parametric data, independent sample t-test

will be used to compare between two groups in non-related samples for baseline

comparison. For non-parametric data, Mann Whitney test will be used to compare

between two groups in non-related samples for baseline comparison. Chi square

test/Fischer’s exact test will be used to compare for proportions between intervention

and control arms. The change in outcomes between the two groups will be compared

using two-way ANOVA. The proportions will be reported with 95% confidence

interval. The statistical significance level will be set at P less than or equal to 0.05