Treatment Outcomes of Partial Pulpotomy Using Two Different Calcium Silicate Materials in Cariously Exposed Mature Permanent Teeth: A Randomized Clinical Trial
Phase: PHASE4
Conditions: Deep Dental Caries
Sponsor: Firat University

 
STUDY PROTOCOL 
 
Treatment outcomes of partial pulpotomy using two different calcium silicate materials 
in cariously exposed mature permanent teeth: A randomized clinical trial 
 
NCT number: has not been created yet 
Date of creation: 05.12.2023 
 
In this clinical trial, patients will be blinded; they will not be aware of the material used. Both the clinicians 
conducting the clinical and radiographic evaluations and the statistician analyzing the data will be blinded to the 
materials used. Due to the different application procedures of the two materials used, it is not possible for the 
clinician administering the treatment to be blinded. 
 
After the necessary clinical examination, volunteers meeting the inclusion criteria will be randomized into two 
groups (n=30 each) by an independent clinician using a randomization table, and this information will be 
documented in patient cards. All volunteers will receive standard oral hygiene training prior to treatment. The two 
different calcium silicate-based materials (Biodentine or TheraCal PT) will be applied according to the 
manufacturers’ recommendations and as outlined in their usage instructions. All treatments will be performed by 
a single endodontist using dental magnification. 
 
The treatment procedure for both groups after the removal of decay and partial removal of the exposed pulp is 
identical and outlined below: 
 
Prior to treatment, a periapical radiograph of the relevant tooth will be taken for diagnostic purposes using a parallel 
technique facilitated by a radiograph holder. The process will involve the patient biting on a small amount of 
silicone placed in the bite block of the radiograph holder to ensure standardization and quality. This same silicone 
impression will be disinfected and stored under appropriate conditions in the patient's file to be used for subsequent 
radiographs to ensure consistency of the angles (the filled part of the tooth will be adjusted in the silicone to fit 
post-filling). Additionally, high-quality images of the relevant teeth will be taken before, during, and after the 
treatment using a camera. Deep local anesthesia will be achieved using lidocaine with 1/80,000 epinephrine. A 
rubber dam will be placed to isolate the tooth and eliminate contact with the oral environment. Initial decay 
removal will be conducted peripherally using a sterile, high-speed diamond bur. Deeper layers of decay will be 
removed using a series of sterile, low-speed burs of varying diameters. Once the decay is fully removed and the 
pulp tissue exposed, the initial partial removal of the pulp tissue will be performed using a new sterile high-speed 
bur. After examining the area for residual decay, a 5.25% NaOCl solution will be used to irrigate the cavity for the 
initial removal of carious dentin shavings and disinfection of the tissue and cavity. For hemorrhage control, a moist 
cotton pellet soaked in NaOCl will be placed on the pulp wound surface for 2 minutes. If bleeding continues, a 
new sterile cotton pellet soaked in 5.25% NaOCl solution will be placed for another 2 minutes. If bleeding persists 

after the removal of the new cotton pellet, a second partial pulpotomy will be performed to reach non-inflamed 
pulp tissue, and the previous procedure will be repeated. Bleeding will be checked every 2 minutes up to 10 
minutes; if it stops at any of these intervals, pulp capping will be performed. If bleeding continues for more than 
10 minutes, the case will be deemed unsuitable for continuation with the current treatment, and total pulpotomy 
or root canal therapy will be considered. Once hemostasis is achieved, the pulp capping material (Biodentine or 
TheraCal PT) will be placed (detailed descriptions of these steps are provided below). Subsequently, the tooth will 
be restored with permanent composite material, and photographs of the filling will be taken along with a periapical 
radiograph using the silicone impression. Post-treatment routine advice and postoperative pain information will be 
provided to the patient, and they will be asked to fill out the postoperative pain scale for the first week after 
treatment and note any medications and dosages used if applicable. Follow-up visits at 1 week (for pain assessment 
only) and at 3, 6, and 12 months will be conducted. During these follow-ups, necessary clinical examinations 
(percussion, palpation, presence-absence of sinus tract) will be performed, vitalometric assessments recorded, 
radiographs taken using the silicone impression, and evaluations of lamina dura, presence of lesions, and canal 
obliteration conducted, along with scoring of filling quality. If issues such as pain, swelling, sinus tract formation, 
or lesion development are detected during follow-up, root canal treatment will be administered, and the case will 
be deemed a failure. Radiographic follow-up evaluations of the patients will be independently performed by two 
endodontists not involved in the study. 
 
Biodentine Group: After mixing the Biodentine material according to the guidelines provided in the application 
manual, it will be placed vertically over the hemostatically treated pulp using a carrier to ensure no exposed pulp 
remains. After a setting time of 12 minutes, a self-etch bond will be applied around the material, thinned with air, 
and light-cured. Flowable composite will then be placed over the Biodentine material and light-cured. Next, 
selective etching of the enamel will be performed in the cavity, washed off with water, dried, then self-etch bond 
applied and light-cured, followed by layering of the composite filling. If possible, filling procedures will also be 
performed under the rubber dam. If issues arise with matrix placement under the rubber dam, the Biodentine 
surface will be completely covered with flowable composite and light-cured; subsequently, the rubber dam will be 
removed, and filling will continue. 
 
TheraCal PT Group: TheraCal PT material will be placed over the hemostatically treated pulp using the injector 
tip found in its package to ensure no exposed pulp remains, and light-cured for 10 seconds. Subsequently, self-
etch bond will be applied over and around the material, thinned with air, and light-cured. Flowable composite will 
then be placed over the TheraCal PT and light-cured. Remaining procedures are identical to those for the 
Biodentine group.