Condition category
Oral Health
Date applied
08/06/2015
Date assigned
23/06/2015
Last edited
25/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

Sponsor information

Organisation

King Saud University

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27553664

Publication citations

Additional files

Editorial Notes

25/08/2016: Publication reference added.