Mineral trioxide aggregate (MTA) as an alternative root canal filling material

ISRCTN	ISRCTN15285974
DOI	https://doi.org/10.1186/ISRCTN15285974
Protocol serial number	CDRC FR0235
Sponsor	King Saud University
Funder	King Saud University

Submission date: 08/06/2015
Registration date: 23/06/2015
Last edited: 25/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Reem Alsulaimani
Scientific

King Saud University
College of Dentistry
Department of Restorative Dental Science
Riyadh
11545
Saudi Arabia

ORCID ID	0000-0002-3275-3598
Phone	+966114677420
Email	reem@ksu.edu.sa

Study information

Primary study design	Interventional
Study design	Interventional single-centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of periapical healing following apical filling with mineral trioxide aggregate in mature teeth: a randomized controlled trial
Study acronym	MTAO - Mineral Trioxide Aggregate Obturation
Study objectives	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(s)	Institutional Review Board and Ethical Approval Committee at the College of Dentistry, King Saud University, 18/05/2015, ref 353621 (FR 0235).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Periapical healing assessed by conventional periapical radiographs. Measured 5 times, every 12 month post-operative for 5 years.
Key secondary outcome measure(s)	Periapical healing assessed by cone beam computed tomography. Measured twice, 1st and 5th year only.
Completion date	01/06/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	100
Key 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.
Key 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.
Date of first enrolment	07/03/2010
Date of final enrolment	26/06/2018

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

King Saud University

King Abdullah Road
P.O. Box 60169
Riyadh
11545
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/08/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/08/2016: Publication reference added.