Clinical trial NCT02783911
Conditions: Primary Teeth Pulpotomy
Keywords: Clinical and Radiograph
Sponsor: Loma Linda University
Start date: 2015-01-29; Completion date: 2017-03-14
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months.

Detailed description:
Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months. Regular recall and follow up will be performed for patients who has MTA or FS pulpotomies. Clinical and radiographic findings will be recorded.

Arms: arm 1: Subject with pulpotomy treated with MTA MTA paste (\< 1gm) will be placed on pulp orifice once for the life of the primary teeth arm 2: Subject with pulpotomy treated with FS FS paste (\<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth
Interventions: intervention 1: MTA intervention 2: Ferric Sulfate
Intervention descriptions: intervention 1: Mineral Trioxide Aggregate grey paste intervention 2: Ferric Sulfate paste

Protocol documents:
ICF_002.pdf: 
Title page:                   
 
Title: Comparison of Clinical and Radiographic Success Between:  
Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary Molars.  
 
NCT 02783911 
 
Date: Jan 09, 2015 
 



 
LOMA LINDA UNIVERSITY 
·-
-
... 
School of Dentistry 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
STUDY TITLE: 
Cbmparison of Clinical and Radiographic Success between Mineral Trioxide Aggregate (MTA} & 
Ferric Sulfate (FS) Pulpotomies for Primary Molars. 
PRINCIPAL INVESTIGATOR: 
Jung-Wei Chen, DDS, MS, and PhD 
Program Director/Advanced Specialty Education in Pediatric Dentistry 
Loma Linda University School of Dentistry 
Loma Linda, CA 92350 
Purpose of Study 
The purpose of this study is to compare the efficacy of two different medicines, mineral trioxide aggregate (MTA) and 
ferric sulfate (FS), used in performing baby root canals. Your child is invited participate in the study because your child's 
dentist has recommended dental treatment involving a root canal. The medicines, MTA and FS, are not experimental 
and are frequently used in patients everyday. Our goal is to determine if there is any difference in the success rates of 
one medicine over another. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website 
will not include information that can indentify you. At most, the website will include a summary of the results. You can 
research this website at any time. 
Approximately 60 subjects will participate in this study. 
Study Procedures 
Participation in this study involves the following: 
•
Before your child receives pulp treatment, he or she will be randomly assigned to one of two study groups using
a process similar to flipping a coin.
•
Subjects in Group MTA will be treated with MTA as the pulpal medicine prior to the final stainless steel crown
restoration.
•
Subjects in Groups FS will be treclted with FS as the pulpal medicine prior to the final stainless steel crown
restoration.
•
Your child will return at 3 months, 6 months, 9 months, and 12 months for a clinical and x-ray evaluation of the
subject tooth, which is routine and the standard of care. If the observed tooth has a failed treatment or
increased mobility because it is ready to fall out, we will extract the tooth before the end of the observation
period. Your child will not have to continue with the study's scheduled clinical and x-ray evaluations of the
subject after the extraction. Your child will return to his or her routine check-up schedule.
•
Your child will receive a routine periodic examination, teeth cleaning, and fluoride treatment at 6 months and 12
months.
Page 1 of 3 
lomll Linda U11i•1ersity 
Adventist Hea!th Sciences Center 
Institutional Re\"iew Bo.1rd 
Appro\·ed 1 /et/IX Void after./U.@/Jol,5 
# 5lYQU2,.
rclrnir (l -J_. -

























Prot_000.pdf: 
Title page:                   
 
Title: Comparison of Clinical and Radiographic Success Between:  
Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary 
Molars.  
 
NCT 02783911 
 
Date: Sep 02, 2014 
 
 
 


 
 
 
 
Statement of Problem  
Premature loss of a tooth from caries or trauma can lead to malocclusion and/or to 
esthetic, phonetic, function problems, super eruption of the opposing tooth and costly 
procedures to correct and maintain space.  A pulpotomy is one type of treatment for vital 
pulp therapy. The aim of the treatment is to preserve the radicular pulp, avoiding pain and 
swelling, to retain the tooth and preserve arch integrity.  
 
Formocresol (FC) has a long history for pulpal medicament with a success rate of up to 
97%.  Its use, however, has been questioned due to published studies raising concerns for 
systemic distribution, carcinogenicity, mutagenicity, and immune sensitization.  These 
concerns have led to the search and use of different materials and techniques to replace 
FC as a pulpal medicament that is cost effective, safe, and predictable.  Calcium 
hydroxide, diluted formocresol, electrosurgery, lasers, ferric sulfate (FS), mineral trioxide 
aggregate (MTA), and sodium hypochlorite have been used as alternatives to FC for pulp 
therapy.  Of these alternatives, MTA and FS have the most similar clinical and 
radiographic success as FC but the number of studies evaluating their success is limited 
in primary teeth.  There has not been any study comparing MTA to FS for use in primary 
molar pulpotomies.   
 
The purpose of this study is to evaluate which of these materials, gray MTA (GMTA) or 
FS, has the best long-term success rates with the least amount of adverse effects in 
primary molar pulpotomies. We will clinically and radiographically compare the success 
rates of MTA and ferric sulfate pulpotomies in primary teeth. 
 
Review of Literature  
1) Pulpotomy is still the most common treatment for cariously exposed pulps in 
symptom-free primary molars. The aim of this treatment is to preserve the 
radicular pulp, avoiding pain and swelling, and ultimately to retain tooth and thus 
preserve arch integrity. The desired end result is the timely exfoliation of the 
treated tooth and its replacement by a permanent successor. The procedure can be 
briefly described: following removal of coronal ceiling of the pulp, the coronal 
pulp is amputated using either a sharp excavator or a slowly revolving large round 
bur. A pulp dressing agent is applied and a base of zinc oxide-eugenol (ZOE), 
either plain or reinforced, is placed over amputation site, immediately followed by 
a final restoration, preferably a stainless-crown. (Fuks, A.B., 2012)  
2) Formocresol (FC) has been a popular pulpotomy medicament in the primary 
dentition for the past 60 years, and is considered the most universally taught and 
preferred pulp therapy for primary teeth (Eidelman, E., 2001). 
3) Concerns have been raised about the toxicity and potential carcinogenicity of FC 
in humans, and alternatives have been proposed to maintain partial pulp vitality 
(Eidelman, E., 2001). 


4) A 2008 survey detected a trend away from the teaching of 1:5 diluted 
formocresol, with more using ferric sulfate for pulpotomy (Casamassimo, P. S., 
2013) 
5) Ferric Sulfate is proposed as a pulpotomy agent on the theory that its mechanism 
of controlling hemorrhage might minimize the chances for inflammation and 
internal resorption believed by some investigators to be associated with 
physiological clot (Smith, N.L., 2000)  
6) The most frequently observed pulpal responses were calcific metamorphosis and 
internal resorption. Sometimes (n=5) both responses were observed in the same 
tooth (Smith, N.L.,2000)  
7) Clinically,86.6% success rate was found in ferric sulfate group whereas 100% 
success rate was found in electrosurgical and diode laser groups (Yadav, P., 2014)  
8) MTA has many desirable properties such as biocompatibility, alkaline pH, 
radiopacity, excellent sealing capacity, the ability to harden in presence of 
humidity, the formation of dentin, cement, and bone (Chen, J.W., 2012) 
9) MTA is a biocompatible material and its sealing ability is better than that of 
amalgam or zinc oxide-eugenol. It is a powder that sets in the presence of 
moisture with a pH of 12.5. The setting time of the cement is 4 hours and its 
compressive strength is 70 MPA, which is comparable with that of IRM 
(Torabinejad, M., 1999). 
 
 
Methods and Materials  
      Children between the ages of 4-9, with first or second primary molars with normal or 
reversible pulpitis that have vital carious pulp exposures due to caries and pulps that 
bleed when entering the pulp chamber. No clinical symptoms or evidence of pulp 
degeneration, such as excessive bleeding from the root canal, history of swelling, 
mobility, or sinus tract. No radiographic signs of internal or external root resorption, 
inter-radicular and/or periapical bone destruction, or furcation radiolucency. No more 
than one third physiologic root resorption has occurred. Teeth that will be retained for 12 
months after the pulpotomy procedure and stainless steel crown restoration, will be asked 
to participate in this study. Children can be ASA I or II that have cooperative behavior 
that will enable follow-up appointments for examinations and radiographs.  Children 
meeting the criteria for this study will be treated at Loma Linda University’s Pediatric 
Dental Clinic, LLU Children’s Hospital with general anesthesia, or Koppel Special Care 
Dentistry Center at LLU.  
 
      Prior to pulpotomy treatment, the subjects will be randomly assigned into two groups: 
1) MTA pulpotomy with stainless steel crown or 2) ferric sulfate with stainless steel 
crown. Operators involved will draw blindly into a box that has 60 papers: 30 marked 
MTA and 30 marked FS. The teeth will be anesthetized using 2% lidocaine with 
(1:100Kepi). The tooth will be isolated using a rubber dam. A new slow-speed #6 or #8 
round bur will be used to remove caries. A new #330 carbide bur and a high speed will be 
used to access pulp chamber. Hemostasis will be achieved with direct pressure from a 
sterile cotton pellet moistened with sterile water. MTA or FS (whichever randomly 
assigned) will be placed onto pulpal stumps. ZOE B&T mixture will be placed into pulp 


chambers. Molar will be immediately restored with a stainless steel crown cemented with 
Ketac-Cem Liquid. A post procedure bitewing radiograph, that shows the subject’s tooth 
furcation and complete root, will be taken.  
 
    Follow-up appointments at 6 months, 9 months, and 12 months will be completed for 
subjects. The follow-up appointments will consist of a clinical examination and bite-wing 
view periapical radiographs to determine success(s)/failure(s) of two different 
pulpotomized teeth.  
 
The criteria for a successful pulpotomy will include:  
 retained for the length of the study or exfoliate naturally 
 normal bone trabeculation in the periapical region 
 no abscess or fistula 
 contained internal resorption is acceptable 
 calcific metamorphosis is acceptable 
 
    When the teeth exfoliate or require extraction, the teeth with pulpotomies will be 
collected and histologic slices will be completed to analyze for what types if any cellular 
changes from the use of the pulpal medicaments.  
 
 
 
Statistical Analysis:  
Data and statistical analysis will include descriptive and inferential statistics.  
Inferential statistical analysis will use SPSS 16 (SPSS, Chicago, IL) with a significance 
level set at P≤ 0.05 
 
 
Budget: 
 
Item 
Units 
Needed 
Price/Unit 
Total Price 
Patient incentive – follow-up visits 
60 
$50 
$3000 
Mineral Trioxide Aggregate 
5 dose 
packets 
$475 
$475 
Ferric Sulfate 
1 
$35 
$35 
3M Stainless steel crowns 
60 
$5 
$300 
Copying, stationery , paper, pen, 2 clip 
board  
 
 
$300.00 
Total 
 
 
$4,110 
 
Proposed Research Milestones: 
Continuation of Established IRB#: 5140262 
March 2016: 
 Data collection 


 
March 2016: 
 Proposal preparation and submission for approval by the Research Guidance 
Committee 
 
April 2016:  
 Protocol preparation, submission, and approval by Loma Linda University School 
of Dentistry Research Committee 
 
 
June 2016- June 2017: 
 Data analysis and article preparation for review and submission 
 
 
References:  
 Casamassimo, P. S. (2013). Pediatric Dentistry Infancy Through Adolescence.  
       St. Louis, Missouri, Elsevier Saunders. 
 
 Chen, J. W. (2012). "Materials for primary tooth pulp treatment: the present and the 
future." Endodontic Topics 2012 23: 41-49. 
 
 Eidelman, E., Holan, G., Fuks, A.B. (2001). "Mineral trioxide aggregate vs. 
formocresol in pulpotomized primary molars: a preliminary report." Pediatric 
Dentistry 23(1): 15-18. 
 
 Smith, N.L., Seale, S.N., Nunn, M.E (2000). “Ferric sulfate pulpotomy in primary 
molars: A retrospective study.” Pediatric Dentistry 22(3):192-199 
 
 Fuks, A.B., Guelmann, M., Kupietzky, A. (2012). “Current developments in pulp 
therapy for primary teeth.” Endodontics Topic 2012 23:50-72 
 
 Yadav, P., Indushekar, K.R., Saraf, B.G, Sheoran, N., Sardana, D. (2014). 
“Comparative evaluation of Ferric Sulfate, Electrosurgical and Diode Laser on human 
primary molars pulpotomy: an “in vivo” study.” Laser Therapy 23.1: 41-47  
 
 Torabinejad, M. (1999). "Clinical Applications of Mineral Trioxide Aggregate." 
Journal of Endodontics 25: 197-205. 
 
 
 
 
 
 
 
 


 
 
 

SAP_001.pdf: 
Title page:                   
 
Title: Comparison of Clinical and Radiographic Success Between:  
Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary Molars.  
 
NCT 02783911 
 
Date: Sep 02, 2014 
 
 


 
                     Comparison of Mineral Trioxide Aggregate and Ferric Sulfate:  
                             Pulpal Medicaments for Pulpotomized Primary Teeth  
 
Statistical analysis plan 
The following clinical information were collected from the charts: Mobility, pain, abscess/draining fistula, 
and facial swelling. Exfoliation of the pulp treated teeth was recorded and graded as normal, early, or 
delayed based on the age of the patient at the time of the recall and on the exfoliation status of the 
contralateral tooth. If there is any clinical signs of the above the tooth will be count as clinical failure. 
            Data was analyzed using the Statistical Package for Social Sciences v 16.0 (SPSS Inc., 
Chicago, Ill). The difference between the materials was analyzed using chi-square, Significance 
level was set P<.05.  
 
Chi-Square Tests 
Value 
df 
Asymptotic 
Significance (2-
sided) 
Exact Sig. (2-
sided) 
Exact Sig. (1-
sided) 
Pearson Chi-Square 
.059a 
1 
.808 
Continuity Correctionb 
.000 
1 
1.000 
Likelihood Ratio 
.060 
1 
.807 
Fisher's Exact Test 
1.000 
.603 
Linear-by-Linear Association 
.057 
1 
.812 
N of Valid Cases 
24 
a. 2 cells (50.0%) have expected count less than 5. The minimum expected count is 2.25. 
b. Computed only for a 2x2 table 
 
Summary: The result showed there is no statistical difference in long term clinical success between 
the two pulpotomy medicaments. (MTA vs FS)