Clinical trial NCT05853185
Conditions: Pulpitis - Irreversible
Sponsor: Liaquat University of Medical & Health Sciences
Start date: 2021-10-12; Completion date: 2022-08-30
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Although many pulpotomy agents are commercially available, there is a dearth of clinical research comparing the efficacy of these agents in treating individuals with irreversible pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished from MTA by its superior chemical, physical, and biological properties. This study aims to address this knowledge deficit by assessing the performance of biocompatible materials in pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis without apical periodontitis, this research will compare the success rates of MTA and EBRRM pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the treatment of this disease.

Detailed description:
The goal of this observational study is to test and compare the success of full pulpotomy with Mineral Trioxide Aggregate (MTA) pre-mixed bioceramic in mature teeth with irreversible pulpitis. Participants in this study were patients with irreversible pulpitis without apical periodontal pathosis recruited from the waiting list at the School of Dentistry at Liaquat University of Medical and Health Sciences in Jamshoro. After obtaining informed consent, demographic information, clinical examination results, and binary variables were recorded pre- and intra-operatively. The study's primary aim was to assess postoperative pain, and secondary aims included assessing the presence of swelling, sinusitis, or fistula and detecting tooth mobility. Participants received either MTA or Endo Sequence Bioceramic Root Repair randomly allocated using a lottery system. Follow-up assessments were done initially, after 6 days, and after 6 months, and periapical radiography was done at 6 days and 6 months to detect radiolucency.

Arms: arm 1: Patients in this group will receive the pulpotomy with Pro Root MTA®. arm 2: Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®.
Interventions: intervention 1: Pro Root MTA® intervention 2: EBRRM®
Intervention descriptions: intervention 1: Patients in this group will receive the pulpotomy with Pro Root MTA®. intervention 2: Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.

Protocol documents:
Prot_SAP_ICF_004.pdf: 
Assessing Success of MTA and Pre-
mixed Bioceramic in Mature Teeth With 
Irreversible Pulpitis With Full Pulpotomy. 
(GCP) 
NCT05853185 
Monday, August 21, 2023 
Sarang Suresh 
 
 


STUDY PROTOCOL 
Operational Definition 
Irreversible Pulpitis 
Patients with a history of pain score of greater than 4 on visual analogue scale during clinical 
assessment with lingering of pain for more than 10 seconds on cold stimulus. 
Apical Periodontitis 
Patients with positive response to tenderness on palpation/percussion and presence of 
radiographic rarefaction will be diagnosed as positive for apical periodontitis. 
Success 
Modified Clinical and Radiographic Criteria1 
• Clinical criteria of success 
o No history of spontaneous pain or discomfort except for the first 2 days after 
treatment 
o No tenderness to palpation or percussion and the tooth is functional. 
o Normal mobility with less than 1mm and probing pocket depth less than 4 
mm. 
o Soft tissues around the tooth are normal with no swelling or sinus tract. 
• Radiographic criteria of success 
o No pathosis evident on the radiograph such as root resorption, furcal pathosis 
or new periapical pathosis 
Materials and Methods 
Study Design 
Randomized Controlled Trial (RCT) 
Setting 
This study will be carried out on patients visiting outpatient clinic of Department of 
Operative Dentistry, Institute of Dentistry, Department of Operative Dentistry, LUMHS, 
Jamshoro/Hyderabad 
Duration of Study 
9 months after approval of study from CPSP 
Sampling Technique 
Nonprobability convivence sampling 
Sample Size 
In this trial, based on the results of a previous studies showing a success of 73.8%2 with 
Mineral Trioxide Aggregate and 98.4%1 for other bioceramics for full pulpotomy procedures, 
the proportion in population 1 (P1; Mineral Trioxide Aggregate) and the proportion in 
population 2 (P2 Endosequence Bioceramic Root Repair Material) were determined to be 
total of 64 with 32 in each group based on Kelsey on Openepi with power of 80% with 
confidence level of 95. 


Inclusion Criteria 
• Patients with diagnosis of irreversible pulpitis without apical periodontitis 
• Either gender 
• Lower Age 10 Years – Upper Age 40 Years 
Exclusion Criteria 
• Teeth with signs of resorption 
• Roots with open apices (Immature Teeth) 
• Calcified or blocked canals 
• Iatrogenic perforations 
• Root fractures 
• Non restorable teeth 
• Negative response to cold testing and presence of sinus tract or swelling. 
• No pulp exposure after caries excavation 
• Bleeding could not be controlled after pulpotomy in 10 minutes. 
• Insufficient bleeding after pulp exposure; the pulp is judged necrotic or partially 
necrotic. 
Data Collection 
After approval from CPSP and ethical approval from Liaquat University of Medical & Health 
Sciences. All patients visiting department of operative dentistry institute of dentistry Liaquat 
university of medical and health sciences, Jamshoro with diagnosis of irreversible pulpitis 
without apical periodontal pathosis will be recruited. After meeting with inclusion criteria, 
they will be informed of the details of procedure and their potential consequences and 
informed consent will be obtained. Demographic data including age, sex, as well as universal 
tooth number undergoing treatment will be registered. A history of the chief complaint and a 
clinical examination including visual inspection of the caries status, restorability of the tooth, 
palpation, percussion, probing pocket depth, mobility using dental mirror and probe and 
sensibility via cold testing will be performed. A clinical diagnosis consistent with irreversible 
pulpitis will be established in all cases based on a history of severe spontaneous lingering 
pain that could be reproduced by cold testing. Preoperative periapical radiographs will be 
taken using the parallel technique via a film holder. Pre- and intraoperative data including the 
electric pulp test (EPT, recorded by reading on electric pulp tester) and binary variables 
including the cold test, pulpal/periapical status will also be registered. 
After anesthesia (lidocaine with 1/80,000 epinephrine), complete caries removal, isolation, 
and pulp exposure, the pulp chamber will be unroofed with a sterile bur, and the pulp from 
chamber will then be completely removed with a round-end sterile bur on high speed with 
very low pressure and copious irrigation. After irrigating the chamber with normal saline, a 
sterile cotton pellet soaked in 5.25% sodium hypochlorite will gently left over the orifices for 
10 minutes to achieve hemostasis. After achieving hemostasis, each tooth will randomly be 
allocated to 1 of 2 parallel arms using a coin toss test performed by a dental assistant who 
will not be involved in the study. The pulpotomy agent MTA and EndoSequence Bioceramic 
Root Repair will then be prepared according to the manufacturer’s instructions and placed 
over the orifices with a thickness of approximately 2–3 mm. The cement will then be covered 
by a layer of light-cured glass ionomer and the remaining cavity will then be restored with 


resin-bonded composite. In case of unsuccessful after pulpotomy, teeth will be managed by 
other pulp therapy techniques. 
Data Analysis 
Primary outcome for clinical success will be clinical parameters which will be described in 
binary units, including post-operative pain which will be performed by asking the patient if 
there is pain either continuous or intermittent, swelling through visual examination, sinus, or 
fistula through visual examination of the gingiva and tooth mobility by back of mirror to 
detect mobility in any direction. This assessment will be performed throughout the study at 
baseline, 6 days, and 6 months. Secondary outcome will be radiographic assessment to detect 
presence of radiolucency described in binary at baseline, 6 days, and 6 months through 
periapical radiograph. 
All data will be collected and analyzed in SPSS Version 27. Qualitative data will be 
presented as frequencies and percentages. Quantitative data will be presented as mean and 
standard deviation. Chi-square test and Fisher’s Exact test will be used for comparisons 
clinical parameters in two groups. Student’s t-test will be used to compare between mean age 
values in the two groups. Friedman’s test will be used to study the changes by time within 
each group. Kaplan-Meier survival curve will be constructed to calculate the mean survival 
estimates of the two groups. Comparison between survival times will be performed using Log 
rank test. The significance level will be set at P ≤ 0.05. 
 
 


Consent Form 
I UNDERSTAND that dental treatment requiring PULPOTOMY THERAPY PROCEDURES, 
which I desire to have performed, include certain risks and possible unsuccessful results or 
procedural failure. Even though care and diligence will be exercised in this treatment, there are 
no guarantees of desired or anticipated results, or of the longevity of the treatment. I AGREE 
to assume the risks, possible unsuccessful results or procedural failure associated with the 
treatment, including but not limited to the following: 
• I understand that a pulpotomy is an interim treatment done with the intention of 
temporarily preserving a vital permanent tooth without removing all the pulpal or nerve 
tissue. It is also a procedure which helps to maintain a baby, or primary tooth that is 
infected, thus preventing premature loss. 
• Even though it is anticipated that this treatment may extend the time in which a tooth 
will remain vital until further necessary procedures may be successfully performed at a 
more appropriate time, it will be necessary to perform complete root canal therapy as 
soon as practical. Care should be taken not to unduly delay completion of the root canal 
process. Referral to an endodontic specialist may be necessary as determined by the 
attending dentist. 
• There is always the possibility of injury to the nerves of the face or tissues of the oral 
cavity during the administration of anesthetics, or during the treatment procedures 
which may cause a numbness of the lips, tongue, tissue of the mouth, and/or facial 
tissues. This numbness is usually temporary but may be permanent. 
• In as much as the crown portion of the tooth may have been weakened due to the 
extensive nature of the procedure and/ or that the tooth injury or disease which 
necessitated this procedure, the tooth may be more susceptible to fracture or breakage. 
Removal of vital tissue within the tooth causes it to dehydrate, and that can lead to 
fracture. 
• Should the tooth structure, which is remaining appear to be excessively compromised, 
it may be necessary to place a temporary crown on the tooth to preserve it. 
• Should the tooth not heal properly, experience an extensive fracture, or become unable 
to have complete root canal therapy performed, extraction of the tooth may be the only 
alternative. 
• In most cases, once the pulpal tissue has been removed, and the initial pain has 
subsided, the tooth usually becomes pain free. However, in some cases, severe pain or 
extreme sensitivity will persist. If so, it is the patient’s responsibility to notify the dentist 
immediately. 
• It is my responsibility to contact the dentist and seek attention should any abnormal 
postoperative circumstances occur. 
• I will diligently follow any preoperative and postoperative instructions given me. 
 
 


As indicated my signature below, the doctor and dental team have given me the opportunity to 
read this document in its entirety and have allowed me to ask all questions pertaining to the 
procedure(s) above, their nature and purpose. They have also explained to me alternative forms 
of treatment and the risks of nontreatment. They have answered all my questions and concerns 
to my satisfaction with language I could understand. I voluntarily assume all possible risk, 
including risk of substantial harm, if any, which may be associated with any phase of this, or 
any unforeseen additional, dental treatment in hopes of obtaining the desired results for me, or 
for my minor child or ward. I also voluntarily assume the risk that the desired result may not 
be achieved. I have also been given the option to seek treatment from a specialist. No 
guarantees or warranties have been made to me concerning the results. Moreover, the fee(s) 
associated with these services have been explained to me, and I accept the financial 
responsibilities. 
By signing this form, I am willingly, under no duress, giving my consent to allow and authorize 
the doctor, dental team members, and their associates, to render any treatment they believe 
necessary, appropriate, and/or beneficial to me, or my minor child or ward, including the 
administration and prescribing of any/all anesthetics and/or medications. 
Patient’s Name 
 
 
 
Signature 
Doctor’s Name 
 
 
 
Signature