Mineral trioxide aggregate (MTA) as an alternative root canal filling material
| ISRCTN | ISRCTN15285974 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15285974 |
| Secondary identifying numbers | CDRC FR0235 |
- 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
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
Contact information
Scientific
King Saud University
College of Dentistry
Department of Restorative Dental Science
Riyadh
11545
Saudi Arabia
 ORCID ID |
0000-0002-3275-3598 |
|---|---|
| Phone | +966114677420 |
| reem@ksu.edu.sa |
Study information
| Study design | Interventional single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant 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. |
| 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 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(s) | Institutional Review Board and Ethical Approval Committee at the College of Dentistry, King Saud University, 18/05/2015, ref 353621 (FR 0235). |
| 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 |
| 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 study start date | 05/02/2010 |
| Overall study end date | 01/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| 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 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
Study participating centre
P.O. Box 60169
Riyadh
11545
Saudi Arabia
Sponsor information
University/education
King Abdulla Road.
P. O. Box 60169
Riyadh
11545
Saudi Arabia
"ROR" |
https://ror.org/02f81g417 |
|---|
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- جامعة الملك سعود, KSU
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/08/2016 | Yes | No |
Editorial Notes
25/08/2016: Publication reference added.
