Comparative Assessment of Clinical and Radiographic Success of Pulpotomy with Cold Ceramic and CEM Cement in Primary Second Molars: a Randomized Controlled Clinical Trial
Determining the clinical success of pulpotomy with cold ceramic in primary second molars at 6-month follow-up
Determining the clinical success of pulpotomy with cold ceramic in primary second molars at 12-month follow-up
Determining the clinical success of pulpotomy with CEM cement in primary second molars at 6-month follow-up
Determining the clinical success of pulpotomy with CEM cement in primary second molars at 12-month follow-up
Determining the radiographic success of pulpotomy with cold ceramic in primary second molars at 6-month follow-up
Determining the radiographic success of pulpotomy with cold ceramic in primary second molars at 12-month follow-up
Determining the radiographic success of pulpotomy with CEM cement in primary second molars at 6-month follow-up
Determining the radiographic success of pulpotomy with CEM cement in primary second molars at 12-month follow-up
Design
A clinical trial with Cold Ceramic and CEM Cement groups, with crossover, double-blind, randomized, on 24 patients and 48 teeth. The envelope method was used for randomization.
Settings and conduct
The experiment will be conducted in the pediatric department of Shahid Beheshti Dental School. Isolation will be done with rubber dam. After caries removal, pulpotomy treatment will be performed on the teeth according to the assigned group. The teeth in both groups will be restored with stainless steel crowns. Clinical and radiographic results will be evaluated after 6 and 12 months. The participant and the statistician will be blinded.
Participants/Inclusion and exclusion criteria
Children aged 4-9 years with at least two deciduous second molars requiring pulpotomy in one jaw will be included in the study.
Intervention groups
In one group, pulpotomy is performed with Cold Ceramic and in the other group, pulpotomy is performed with CEM Cement.
Main outcome variables
Performing pulpotomy with higher success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250712066460N1
Registration date:2025-08-04, 1404/05/13
Registration timing:prospective
Last update:2025-08-04, 1404/05/13
Update count:0
Registration date
2025-08-04, 1404/05/13
Registrant information
Name
Mobina Habibollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 5350
Email address
mobina.habibollahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Assessment of Clinical and Radiographic Success of Pulpotomy with Cold Ceramic and CEM Cement in Primary Second Molars: a Randomized Controlled Clinical Trial
Public title
Comparative Assessment of c Success of Pulpotomy with Cold Ceramic and CEM Cement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with healthy systemic conditions (ASA1)
Children with at least 2 primary second molars requiring pulpotomy (in one jaw)
Children with Frankel cooperation levels 3 and 4
Children or parents voluntarily agree to participate in the study and sign the consent form
Exclusion criteria:
Teeth with evidence of pulp necrosis
Teeth with signs of irreversible pulpitis (hyperemic pulp)
Teeth with pathological external or internal resorption
Unrestorable teeth
Age
From 4 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
2
In each individual, both the right and left primary molars in one jaw are included in the study.
Randomization (investigator's opinion)
Randomized
Randomization description
To ensure allocation concealment and reduce selection bias, a two-step sealed envelope randomization method was employed. For each participant, two sets of opaque, identical envelopes were prepared. In the first set, one envelope was labeled “R” (right) and the other “L” (left), indicating the side of the mouth. In the second set, one envelope was labeled “1” and the other “2”, representing the two intervention groups: Cold Ceramic and CEM cement.
At the time of treatment, each participant was asked to randomly select one envelope from each set. The envelope drawn from the first set determined the tooth side (right or left) to be treated, while the envelope from the second set determined which material would be used on that side. Consequently, the opposite side received the alternative material. This method ensured that the assignment of the materials to each side was randomized and unbiased for each patient.
The entire process was conducted by an independent operator not involved in the clinical procedures or outcome assessments.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the similarity of the preparation steps and the appearance of the two materials, the child participating in the study was unaware of the material used. After the study, the teeth treated with Cold Ceramic were named Group A and the teeth treated with CEM Cement were named Group B, and their results were reported to the statistician, as a result of which the statistician was unaware of the nature of each group.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti university of medical sciences