Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06325540 |
Other study ID # |
pulpcapping |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2023 |
Est. completion date |
February 15, 2024 |
Study information
Verified date |
March 2024 |
Source |
Saglik Bilimleri Universitesi |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to compare the clinical success of theracal pt, therabase,
and biodentine indirect pulp capping on primary molars with deep dentin caries. Indirect pulp
capping was used on the primary molars of the participants with deep dentin caries. It is
aimed to compare the success of biodentine, which is considered the gold standard used in
capping treatments, and the currently marketed Teracal PT and Therabase materials after 1, 6
months and 1 year, with biodentine and with each other, and find out which material is more
successful.
Description:
This study utilized a parallel group, randomized controlled design and enrolled patients who
visited the Department of Pediatric Dentistry, Health Sciences University, İstanbul, Turkey,
in the period of 2020-2022. The study protocol was approved by the Health Sciences University
Hamidiye Clinical Research Ethics Committee (7/34).
All procedures were conducted in accordance with the ethical standards of the relevant
national and institutional committees on human experimentation with the Helsinki Declaration
of 1975, as revised in 2013. The parents or legal guardians provided written in formed
consent.
The sample size was calculated using a G*Power program (G*power 3.1 version) for the
distribution of the success rates in the Biodentine, Therabase and TheraCal PT groups
regarding the follow-up periods, the following parameters were used: medium effect size f
0.34, error = 0.05, minimum 80% power. Based on these parameters, the total sample size was
calculated as 28 participants for each group.
This study was conducted as a prospective clinical and radiographic evaluation. A total of 76
teeth (first and second primary molars) from 5- to 9-year-old healthy and cooperative
children with nonclinical and radiographic evidence of infection symptoms and with
indications for indirect pulp treatment were included in this study. The teeth were divided
into three groups according to the pulp capping materials.
Inclusion and exclusion criteria:
Healthy patients aged 5-9 years were recruited from the pediatric dental clinic at Health
Sciences University. Based on the clinical and radiographic examinations, the inclusion
criteria were previously untreated first and second primary molars in cooperative children
with good general health, which had deep dentin caries involving occluso-proximal surfaces
but showed positive response to vitality tests (electrical pulp test and cold stimulation)
(Endo Ice, Hygienic; Coltene/Whaledent AG, Altst€atten, Switzerland and Diagnostic Unit;
SybronEndo, Orange, CA); were radiographically detected with caries penetration involving
approximately 3/4 of the dentin thickness; were considered to have a potential to result in
pulp exposure when the entire caries was cleared according to the complete excavation
procedure in which the end point of carious tissue removal is the hard dentin; and showed a
moderate response to chemical and thermal stimuli. Clinical success criteria were as follows:
signs of irreversible pulpitis (such as spontaneous pain, prolonged pain response), presence
of percussion or palpation, pathological mobility, infectious symptoms such as fistula or
abscess, and discoloration in the clinical examination. Radiographic success criteria
included presence of radiolucency in the furcation or periapical regions, thickening of the
periodontal spaces, and internal or external root resorption.
Clinical practice:
Two pediatric dentists screened each patient for inclusion and exclusion criteria during a
preoperative oral examination and participants that met the inclusion criteria were randomly
divided into three groups: Biodentine group (n =25), TheraCal PT group (n=26), Therabase
group (n =25).
Following the application of topical and local anaesthesia injection (2% lidocaine
hydrochloride with epinephrine 1:80,000; Septodont, Saint-Maur-des-Fosses, France),
rubber-dam isolation (Dental Dam, Coltène Whaledent, Langenau, Germany) were performed. The
tooth was disinfected by scrubbing with 2% chlorhexidine. The carious peripheral dentin was
removed using a high-speed dental diamond bur (Dentsply, Dentsply Maillefer, Baillaigues,
Switzerland) and the infected and necrotic soft dentin layer in the center was carefully
removed to prevent pulp exposure. Cavity excavation was stopped when the residual dentin over
the pulp tissue showed increased resistance to manual instrumentation, and the demineralized
dentin (affected dentin) was left at the floor of the cavity. After removal of carious, the
cavities were washed with 2% chlorhexidine gluconate irrigation solution (Klorhex, Drogsan,
Türkiye) and then were dried with an air-water spray and cotton pellets. Biodentine, TheraCal
PT and Therabase materials were applied according to the manufacturer's instructions.
Biodentine group: The entire residual demineralized dentin tissue covered with approximately
1mm tricalcium silicate pulp-capping material, Biodentine
(Septodont,Saint-Maur-des-Fossés,France) by avoiding the placement of the material on enamel
or margins of the cavity. After application of Biodentin, 12-min setting time was allowed for
setting, in accordance with the recommendations of the manufacturer.
Theracal PT group: The entire residual demineralized dentin tissue covered with maximum
thickness of 1mm flowable form of resin-modified calcium silicate-containing material,
(TheraCal PT,Bisco Inc.,Schaumburg,IL,USA) by avoiding the placement of the material on
enamel or margins of the cavity. After appllication of TheraCal PT, the polymerization for
20s (Elipar Deep Cure; 3 M ESPE, St. Paul, MN, USA), in accordance with the recommendations
of the manufacturer.
Therabase group: The entire residual demineralized dentin tissue covered with maximum
thickness of 1mm flowable form of dual-cured, calcium and fluoride releasing, self-adhesive
base/liner material Therabase (Therabase PT,Bisco Inc.,Schaumburg,IL,USA) by avoiding the
placement of the material on enamel or margins of the cavity. After appllication of TheraCal
PT, the polymerization for 20s (Elipar Deep Cure; 3 M ESPE, St. Paul, MN, USA) in accordance
with the recommendations of the manufacturer.
Afterwards, in all three groups, glass ionomer cement consisting of powder and liquid (Ketac
Molar Easy Mix 3M ESPE, Germany) was placed on each capping material. Following the etching
and bonding process, permanent restoration was finished with composite resin (Filtek Z250
Universal Restorative System, 3M ESPE DentalProducts, USA).
Clinical and radiographic examination: The patients were called for follow-up at 1 months, 6
months and 1 year during the first year. At each follow-up visit, a clinical examination was
performed to assess the presence of tenderness to percussion or palpation, spontaneous pain
or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess,
and pathological mobility. Additionally, a radiographic examination was performed to assess
the presence of lesions in the furcation or periapical regions, internal or external root
resorption, and thickening of the periodontal spaces. The teeth detected with at least one of
these findings were considered 'unsuccessful.'
Statistical analysis All statistical analyses were performed by using software (SPSS, IBM
SPSS Statistics 2022). Normality and homegenity of the data were evaluated by using
Kolmogorov-Smirnov and Levene's Homogeneity tests. Pearson chi-square and Kruskall-Wallis H
tests were performed to analyze data at the 95% confidence level (P = 0.05).