Plain English Summary
Background and study aims
Periapical periodontitis is a lesion around the top (apex) of a tooth root caused by bacterial invasion of the pulp of the tooth. The primary goal of root canal obturation is to prevent the spread of bacteria and bacterial toxins from the canals into the periapical tissues. Any residual bacteria not eliminated during root canal instrumentation should be sealed by the obturation material and rendered harmless by nutrient deprivation. Gutta percha cones are standard core obturation materials that are compacted into the prepared root canal system using lateral or vertical compaction. However they do not adhere to the dentin surface, thus leaving a gap. Therefore, root canal sealers must be used to seal the space between the gutta percha cones and dentinal walls.
Mineral Trioxide Aggregate (MTA) cement without gutta percha cones has been demonstrated as a successful root canal filling material in immature (young) teeth. The aim of this study is to compare MTA cement with conventional root canal filling (gutta-percha cones and root canal sealers) in mature (adult) teeth.
Who can participate?
Healthy female volunteers requiring root canal treatment
What does the study involve?
Participants will be randomly allocated to one of two groups: control or intervention.
Control group: gutta-percha cones and root canal sealer (AH plus) will be used in warm vertical technique to create 4 mm apical plug after complete cleaning and shaping. The remaining root canal space will be either filled with thermo-plasticized gutta-percha or left for post cementation, depending on the remaining tooth structure.
Treatment group: MTA cement (ProRoot MTA) will used to create 4 mm apical plug after complete cleaning and shaping. The remaining root canal space will be either filled with thermo-plasticized gutta-percha or left for post cementation, depending on the remaining tooth structure.
What are the possible benefits and risks of participating?
Participants will receive root canal treatment and referral for final coronal restoration, follow up visits for 5 years. The treatment and follow up are free of charge.
Where is the study run from?
College of Dentistry, King Saud University (KSU) and under the care of College of Dentistry Research Center. Saudi Arabia.
When is the study starting and how long is it expected to run for?
February 2010 to June 2024.
Who is funding the study?
King Saud University (KSU)
Who is the main contact?
Reem Alsulaimani
reem@ksu.edu.sa
Trial website
Contact information
Type
Scientific
Primary contact
Dr Reem Alsulaimani
ORCID ID
http://orcid.org/0000-0002-3275-3598
Contact details
King Saud University
College of Dentistry
Department of Restorative Dental Science
Riyadh
11545
Saudi Arabia
+966114677420
reem@ksu.edu.sa
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CDRC FR0235
Study information
Scientific title
Evaluation of periapical healing following apical filling with mineral trioxide aggregate in mature teeth: a randomized controlled trial
Acronym
MTAO - Mineral Trioxide Aggregate Obturation
Study hypothesis
H0: Periapical healing is not significantly affected by MTA obturation when compared to conventional gutta-percha cones and root canal sealers.
H1: Periapical healing is significantly affected by MTA obturation when compared to conventional gutta-percha cones and root canal sealers.
Ethics approval
Institutional Review Board and Ethical Approval Committee at the College of Dentistry, King Saud University, 18/05/2015, ref 353621 (FR 0235).
Study design
Interventional single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Root canal therapy is indicated when the pulp chamber of a tooth is contaminated by bacteria causing the canals to become infected and development of periapical pathosis. The procedure is accomplished under local anesthesia and rubber dam isolation by creating a small opening in the biting surface of the tooth that will allow it to be disinfected and then sealed with either Gutta percha or Mineral trioxide aggregate (MTA) cement. Gutta percha is a gold standard obturation material whereas MTA demonstrated as successful root end filling material and more recently used as obturation material. The sealing of the canals prevents subsequent passage of bacteria into or out of the tooth.
Condition
Patient requires root canal treatment for teeth with apical periodontitis.
Intervention
Control group: conventional root canal filling with gutta-percha cones and root canal sealer.
Treatment group: Mineral Trioxide Aggregate cement
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Periapical healing assessed by conventional periapical radiographs.
Measured 5 times, every 12 month post-operative for 5 years.
Secondary outcome measures
Periapical healing assessed by cone beam computed tomography.
Measured twice, 1st and 5th year only.
Overall trial start date
05/02/2010
Overall trial end date
01/06/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Included patients will be adult, healthy females who agreed to participate in the study and signed a consent form. The study will include mature teeth with radiographic periapical pathosis greater than 5mm in diameter.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant exclusion criteria
The study sample will exclude teeth that are not restorable, teeth diagnosed with chronic periodontitis with advanced loss of periodontal support, third molars, and teeth with open apex.
Recruitment start date
07/03/2010
Recruitment end date
26/06/2018
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
King Saud University
King Abdullah Road
P.O. Box 60169
Riyadh
11545
Saudi Arabia
Funders
Funder type
University/education
Funder name
King Saud University
Alternative name(s)
KSU
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Saudi Arabia
Results and Publications
Publication and dissemination plan
The results of MTA application in non-surgical setting is complete and at the stage of manuscript writing.
The results of the completed study will be available after completion of 5 years recall.
Intention to publish date
31/12/2025
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27553664