Clinical trial NCT04397094
Conditions: Deep Caries
Keywords: Theracal formocresol pulpotomy
Sponsor: Ain Shams University
Start date: 2017-12-01; Completion date: 2019-03-30
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.

Detailed description:
sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.

Arms: arm 1: Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. arm 2: Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.
Interventions: intervention 1: Theracal LC intervention 2: Formocresol
Intervention descriptions: intervention 1: pulpotomy intervention 2: Pulpotomy

Protocol documents:
Prot_SAP_000.pdf: 
 
   
"TheraCal Pulpotomy in Primary Molars″ 
A Randomized Clinical Trial  
ClinicalTrials.gov ID :  FDASU-Rec ID 101612   
Date : October 21, 2017 
   
Proposal submitted to the Faculty of Dentistry,   
Ain Shams University   
For   
Partial Fulfillment of Requirements of the Doctoral degree in 
Pedodontics   
Title registration: This study will be registered on the Pan African Clinical 
Trial Registry . 
Protocol version: version (1)   
Funding: Self-funding   
Roles of protocol contributor:  
Trial sponsor:   
Faculty of Oral and Dental Medicine Ain shams University - Egypt.   
  
Steering committees:   
1- Department Board.   
2- Research Plan Committee.   
3- Ethics Committee, Faculty of Oral and Dental Medicine - Ain 
shams University   


 
4- Higher Education and Research Committee.   
5- Faculty Board.   
  
Trial design:   
Randomized Clinical Trial (RCT), parallel group with 1:1 allocation ratio.  
  
  
Content  
1- Introduction…………………………………………….. 
2- Objectives………………………………………………..  
3- Study Methodology………………………………………  
4- Study Population……………………………………… 
5- Study Procedure………………………………………....  
6- Data Management……………………………………… 
7- Adverse Events Reporting………………………………  
8- Statistical Analysis……………………………………… 
9- References……………………………………………….  
  
  
  


 
  
 
  
 
  
 Abstract  
Background:TheraCal LC® is a light-cured, resin-modified calcium 
silicate filled liner designed for use in direct and indirect pulp capping, as a 
protective base/liner under composites, amalgams, cements, and other base 
materials. It can be used as a replacement for calcium hydroxide, glass 
ionomer, RMGI, IRM/ZOE and MTA materials. The proprietary 
formulation of TheraCal LC® consists of tricalcium silicate particles in a 
hydrophilic monomer that provides significant calcium release making it a 
uniquely stable and durable material as a liner or base.  
Unique Benefits  
✓ Calcium release which stimulates hydroxyapatite and secondary dentin 
bridge formation.  
✓ The alkaline pH promotes healing and apatite formation.  
✓ Significant calcium release leads to protective seal.  
✓ Moisture tolerant  and radiopaque - can be placed under restorative 
materials and cements.  
Aim of the study: to evaluate the efficacy of TheraCal LC® as a pulp 
medicament in complete pulpotomy in primary teeth.   


 
Methods: The study will be conducted on 60 primary molars with an 
indication for pulpotomy treatment. Primary teeth were treated with either 
formocresol (group A) (30 teeth), TheraCal LC® (group B) (30 teeth) 
using standardized criteria for the pulpotomy procedures. Teeth will be 
clinically and radiographically by digital radiology evaluated during the 
examination period of 3, 6, 12 months.  
1- Introduction  
       Dental caries is considered the most common chronic childhood 
disease, (Dean et al., 2011) 1. It has many profound complications from the 
physiological and social points of view as it reduces food intake, alters sleep 
habits, and increases the number of missed days in school. Moreover, it can 
cause parental work loss. It is not recommended to extract the carious 
molars in young children due to subsequent space loss, blocked out 
permanent teeth, and difficulty eating. Based on that, pulpotomy seems to 
be the treatment of choice for such carious molar (Varags et al., 2006).2  
      Formocresol has been used for decades as a pulpal medicament. Even 
though other materials have been introduced for pulpotomy in primary 
teeth, it proved to be the most efficient, reliable and successful method 
regardless the debate related to its carcinogenicity and toxicity.3   
     
Mineral Trioxide Aggregate (MTA) has been introduced to the field of 
dentistry in the year 1993 by Mahmoud Torabinejad 4. The MTA showed good 
sealing ability, excellent long term prognosis, good biocompatibility and also 
favors tissue regeneration.  
    Recently, TheraCal LC® has been introduced as a light-cured, resin-
modified calcium silicate material. It can be used as a barrier and protectant 
to the dental pulpal complex. The formulation of this product consists of 
tricalcium silicate particles in a hydrophilic monomer. This material can 


 
stimulate hydroxyapatite and secondary dentin bridge formation through 
calcium release and an alkaline pH. It is indicated for direct and indirect 
pulp capping and as a protective base/liner under restorative materials 
including composite, amalgam and cements.   
In their review, Iman Parisay and co-workers reported that Theracal, as 
other materials like Bioaggregate and Biodentin, was evaluated for pulp 
capping but needs further clinical trials to investigate its effect on primary 
teeth. 5  
     The manufacturer of TheraCal LC® product (Bisco dental products 
company) claimed that these new bioactive materials have higher physical 
properties, are easy to handle in clinical practice and are more compatible 
with classical endodontic procedures as well as with all restorative clinical 
cases of dentine replacement.6  
    Continues search for dental materials is never ending, especially for the 
materials needed in pulp treatment procedures.  
  
Impact of this study  
 In this study, TheraCal LC® material will be evaluated as an agent for 
pulp therapy in primary molars based upon the spectacular success rate 
achieved by MTA.   
  
   
 
 
  


 
  
  
Review of literature  
Although some researchers and clinicians used different medicaments 
for many years instead of formocresol for vital pulp therapy in primary teeth 
and inspite of the hundreds of published articles in the literature that support 
the genotoxicity and carcinogenicity of this material, others still prefer the 
use of formocresol.3  
As an alternative material to formocresol, Glutaraldehyde has been 
suggested based on its fixative properties, low antigenicity, and low 
toxicity. Unfortunately, there was a wide range in success rates with this 
alternative material. This might due to the insufficient depth of antibacterial 
affect which in turn may result in a deep zone of chronic cell injury. 
Application of a great amount may result in systemic distribution of this 
agent.7 In addition, the internal resorption might occur as a result of 
inadequate fixation as a deficient barrier is left to sub-base irritation.8  
In 1988, Landau and Johnsen introduced ferric sulphate as a 
hemostatic agent to be used for pulpotomy in primary teeth. It can 
agglutinate the blood protein without presence of a blood clot which 
suggests that it reduces the chance of a blood clot formation.7,9  
In the last two decades, the electrosurgical and laser pulpotomy have 
been suggested as nonchemical devitalization forms to replace the use of 
medicaments.10  
MTA was found to be the future material for pulp therapy in primary 
teeth. It proved high success rate in Indirect Pulp Capping (IPC), Direct Pulp 
Capping (DPC), and Vital Pulpotomy.11  


 
 
Bioactive calcium silicate has shown properties similar to that of the 
MTA regarding, sealing ability, biocompatibility, cytotoxicity, and even 
compressive strength.12   
Apart from the partial pulpotomy technique in primary teeth, Fuks in 
2008 introduced new materials and directions for vital pulp therapy, based 
on the benefits of the IPC, DPC and Vital pulpotomy. This technique could 
be a great solution for chronic pulpitis in primary teeth using new materials 
like MTA and bioactive calcium silicate.11,13  
 In a one-year follow-up study, Schroder et al. investigated the 
differences between partial pulpotomy and calcium hydroxide capping in 
primary molars. The results of the study revealed a significant difference in 
favor to partial pulpotomy than the traditional coronal pulpotomy. The 
authors recommended that partial pulpotomy should be used as the 
treatment of choice in primary molars with chronic coronal pulpitis. They 
emphasized that a gentle surgical technique should be used with no blood 
clot left between the wound and the calcium hydroxide.13  
It has been shown that TheraCal LC® has a chemistry base similar to 
mineral trioxide aggregate (MTA), which has a favorable regenerative 
process as it can stimulate apatite formation14, 15.   
TheraCal LC® is considered a light-cured, radiopaque, and 
regenerative liner which is placed in a thick layer of 1mm (or less) on moist 
dentin. In general, it can be placed directly or indirectly over the pulp or 
over the deepest part of the preparation. This material has an early high pH 
value (10 to 11) which reverting back after several days to reach a neutral 
pH. It has a stimulating high calcium release and can be considered a self-
sealing as well as antimicrobial agent.16, 17  


 
In a follow-up study for 10 months, Jack D. Griffin (2012) applied 
Theracal as a direct liner on a mature central incisor with traumatically 
pulpal exposure. During this period, no clinical symptoms were reported. 
Griffin also stated that Theracal can be used clinically as a general liner 
under different types of restorations such as: before etching or dentinal 
bonding, as a protective liner in restorations placed close to the pulp, as a 
liner over remaining pulp in deciduous pulpotomies or pulpectomies, and as 
a pulp capping material in permanent or deciduous teeth. 18  
In a comparison between Theracal and Biodentin as indirect pulp 
capping materials, both materials are very useful in clinical practice but 
Theracal proved to be the easiest calcium silicate material to use due to its 
efficient syringe, and, as Biodentin, can regulate the mesenchymal cells to 
form odontoblasts.19  
Cannon et al (2014) in their in-vivo study, compared the 
effectiveness of (TheraCal LC, Bisco), pure Portland cement, resin based 
calcium hydroxide and glass ionomer in the healing of contaminated 
primate pulp exposures (exposure of approximately 1 mm). The authors 
concluded that, both the Portland cement and TheraCal groups had 
significantly more frequent hard tissue bridge formation. Moreover, in the 
histologic part of this study, TheraCal LC appeared to have less pulpal 
effects than others.20  
Pulpal exposures, either carious, mechanical or those due to trauma, 
can be treated by placing a thin layer of Theracal directly on the exposure area 
after obtaining a good hemostasis.21  
Haewon Lee et al (2015), evaluated and compared response of the 
pulp to ProRoot MTA (Dentsply Tulsa Dental, Tulsa, OK), RetroMTA 
(Meta Biomed Co, Ltd, Seoul, Korea), and TheraCal (Bisco Inc, 
Schamburg, IL) in dog partial pulpotomy models in four weeks follow up. It 


 
was concluded that, TheraCal produced lower calcific barrier formation, 
higher inflammatory reactions, and less favorable odontoblastic layer 
formation. On the other hand, they reported that a follow up period of four 
weeks is not enough to accurately assess and evaluate the effects of 
Pulpotomy agents.22  
It has been reported that calcium release was higher and solubility 
was low concerning Theracal when compared with ProRoot MTA and 
Dycal.23   
  
  
  
  
  
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  


 
2- Aim of the study (Objectives)  
• The aim of this study is to evaluate the efficacy of a light-cured resin 
modified calcium silicate as a pulp medicament in complete 
pulpotomy in primary teeth.   
  
• Clinical and radiographical follow up will be performed  for 12 
months to investigate the success rate of a light-cured resin modified 
calcium silicate in complete pulpotomy procedures.  
  
      
 
 
 
 
  
   
  
  
  
 
 
 


 
3- Study Methodology  
  
▪ STUDY SETTING  
A randomized clinical trial study is to be conducted from the Outpatient 
clinic of The Pediatric Dentistry and Dental Public Health department, 
Faculty of Dentistry, Ain Shams University.   
  
▪ SAMPLE SIZE ESTIMATION  
To evaluate the effect of TheraCal LC® as a pulp medicament in complete 
pulpotomy in primary teeth, based on a previous study (Bharti et al., 
2015)24, A total sample size of 60 (30 for each group) will be sufficient to 
detect effect size of f =0.59 a power of 95%, and a significant level of 5%. 
Using the z test for testing 2 independent proportions was calculated with 
an anticipated loss to follow-up of 10% included. Done by Raosoft sample 
size calculator was used: URL:http://www.raosoft.com/samplesize.html.  
4-Study Population  
o sixty cases (30 for each group) will be selected from the Outpatient 
clinic of The Pediatric Dentistry and Dental Public Health Department 
, Faculty of Dentistry, Ain Shams University.  
o Screening of patients will continue until the target population is 
achieved. Identifying and recruiting potential subjects is achieved 
through patient database in pediatric dentistry department.  
o Patients between ages 4-7 years old will be selected. Full detailed 
treatment plan will be explained to the parents and children.  
o Following the Ethical Committee of Faculty of Dentistry approval, 
written consents for treatment should be obtained from the children’s 
parents prior to the clinical procedures being executed.  


 
▪ RECRUITMENT:   
Children attending outpatient clinic in Pediatric Dentistry Department- 
Faculty of Dentistry, Ain Shams University- Egypt are screened for 
diagnosis of their chief complaint .patients with vital pulp therapy needed 
only will be enrolled for this study if they were compatible with eligibility 
criteria :-  
Children should be exhibiting: 25, 26, 27  
- No History of any chronic systemic Illness or Hospitalization  
- Co-operative (Rating 3&4 according to Frankle classification)  
The study purpose, benefits and risks will be clarified to the care giver and a 
simplified verbal explanation will be explained to the children before 
participating in the study.  
Criteria for teeth selection25 :   
1. Vital deeply carious mandibular second deciduous molars with large 
carious exposure upon caries removal. 
2. No clinical symptoms or evidence of pulp degeneration, such as pain on 
percussion, history of swelling, or sinus tracts;  
3. No radiographic signs of internal or external resorption and no furcation 
radiolucency or evidence of periapical pathosis  
4. Teeth should be restorable with posterior stainless steel crowns or 
composite restorations.  
5. 2/3 of root length remaining. 
 


 
 
  
▪ RANDOMIZATION  
Allocation:   
o Sequence generation:   
Using computer generated randomization (www.randome.org) eligible teeth 
will be allocated randomly into two groups with1:1 allocation ratio. 28  
o Allocation concealment mechanism:   
The sequentially generated number will be placed in opaque envelope until 
intervention. 
 
Blinding:   
Participants and assessors will be blinded. 
  
  
 
  
  
 
 
  
Table (1): Materials will be used in the study and their composition  


 
Materials  
Manufacturer  
Composition  
                  Formocresol  
  
PrevesTDenPRO,Digiana, Jammu  
,India 
Formo-Cresol (48.5% 
formaldehyde, 48.5% cresol, 3% 
glycerine).  
TheraCal LC  
Bisco, Inc.  
Schaumburg IL, USA  
Light-curing, resin-modified 
calcium silicate filled liner  
single paste calcium oxide,  
calcium silicate particles (type  
III Portland cement), 
strontium glass, fumed silica, 
barium sulphate, barium  
zirconate and resin consisting  
of Bis-GMA and polyethylene 
glycol dimethacrylate  
Zinc Oxide  
PrevesTDenPRO,Digiana, Jammu  
,India  
Pure zinc oxide (dental grade)  
  
  
Eugenol  
  
PrevesTDenPRO,Digiana, Jammu  
,India  
  
Pure Eugenol Oil  (dental grade)  
Highly Viscous Packable Glass 
Ionomer  
Fuji IX, GC Europe  
  
  
(% chemical components by 
WT)  
Alumino silicate glass (95%)  
Polyacrylic acid powder (5%)  
      Stainless Steel Crowns    
3M ESPE St Paul, USA  
100% by Wt  
stainless steel  
  
Ketacfil Plus Aplicap   
3M ESPE, St Paul, USA  
Conventional Glass Ionomer  
  
  
  
  
5- STUDY PROCEDURE  
  
  


 
1. Complete Pulpotomy Group (A) 
29: (30 cases)  
Procedure:  
1. Administration of local anaesthetic  
2. Isolation with rubber dam    
3. Removal of caries  
4. Complete removal of roof of pulp chamber preferably with a non-end 
cutting bur.  
5. Removal of coronal pulpal tissue with sharp sterile excavator   
6. Attain initial radicular pulpal haemostasis by gentle application of sterile 
cotton pledget moistened with saline (haemostasis should be achieved 
within five  minutes)  
20% (1:5 dilution) Buckley’s formocresol solution will be applied to 
radicular pulp on a cotton pledget for five minutes to achieve superficial 
tissue fixation followed by the application of a lining  like zinc oxide 
eugenol cement or reinforced zinc oxide eugenol cement.The primary molar 
is prepared to receive stainless steel crown as a permanent restoration.  
  
2. Complete Pulpotomy using TheraCal LC® (group B) 6 : (30 cases) 
Procedure:  
Steps 1-6 will be done as mentioned above.  
Then TheraCal LC®will be applied directly to the radicular pulp by 
disposal syring tip and light curing will be done for 20 second. Then the 
tooth is prepared to receive stainless steel crown as a permanent restoration.  
o Standardized pre-operative, immediate post-operative radiographs 
and follow up radiographs at 3, 6, and 12 months after treatment 
using Periapical radiographic examination.Preoperative periapical 


 
radiographs of the teeth considered for treatment in the study will be 
obtained by a standardized paralleling technique and an exposure 
time of 0.25 seconds.   
To achieve such technique, the following equipment will be used:   
o 1. An XCP film holder *: An anterior film holder was used and 
trimmed to fit the pedo-sized imaging plate.1  
o 2. Size 0 reusable imaging plate (Photostimulable phosphor 
plate(PSP) receptor) **   
o 3. X-ray machine ***70Kvp,8mA    
 
o Clinical success at follow-up visits should meet the following 
criteria27 :-   
1. Restoration intact;  
2. No spontaneous pain;  
3. No mobility;  
4. No swelling;  
5. No fistula;  
6. No gingival inflammation—represented by pain, redness, or bleeding— 
around the tooth/crown.   
  
Radiographic success at follow-up visits should meet the following 
criteria30:  
1. No external root resorption;  
2. No internal root resorption;  
3. No inter-radicular bone resorption.   
4. No Widening of the periodontal ligament space.   
5.  No periapical bone resorption.  
  
                       --------------------------------------------------------                                    
 
▪ Strategies to improve adherence to intervention protocol   


 
Intense instructions will be  given to parents about the importance of follow 
up visits for the success of intervention treatment.  
▪ Data collection  
• The data will be collected where each patient has a separate file 
containing all the details of the treatment with the written consent of 
the patients. All patients will be recall for follow up periods 3, 6 and 
12 months to evaluate them clinically and radiographically.   
• Intense patient motivation for coming back during follow up periods 
for assessment outcomes with keeping continuous contact with them 
via telephone and visits for oral hygiene measures.  
 6- Data management  
o All data will be entered electronically and double stored for 
safety purpose. Each patient will be given a number for easy 
coding and data management.  
o Confidentiality:   
All study data will be stored securely in a locked file cabinet. All 
recorded data and photos will be stored in safety position with 
password to ensure impossible access by any other person.  
 o Access to data:   
The investigator have full access to the data related to this study.  
  
        
  


 
7- Adverse event reporting  
Any adverse events and other unintended effects of trial intervention or trial 
conduct will be recorded, documented and treated.  
Statistical plan:  
All Data will be collected, checked, revised, tabulated and entered into the 
computer. Data will be presented as frequency and percentage values. Fisher’s 
Exact test will be used at p ≤ 0.05. Statistical analysis will be performed with 
IBM® SPSS® Statistics for Windows (SPSS Inc., IBM Corporation, NY, 
USA).  
 
   
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