Root Perforation at the Bifurcation AreaNCT02805101
Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Sealing Root Perforations
A study testing Biodentine and MTA in people with Root Perforation at the Bifurcation Area, run by Damascus University at 1 site in Syria.
Trial summary
This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two materials are going to be tested in sealing accidental root perforations at the bifurcation areas. The study is going to be conducted as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Root Perforation at the Bifurcation Area
- What is being tested?
- Biodentine and MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- Jan 2015to 30 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- vital molars (upper or lower )
- suffered from perforation in the bifurcation area of the roots through a process of open access cavity, taking into account the location and size of perforation
- Perforation should not exceed the size of 3 mm
- Perforation and must also take into account the time of perforation.
Who cannot join
- If the molar not vital.
- If the perforation not in bifurcation root or extended inside the canals.
- Size of perforation larger than 3 mm.
- A long time ago on the occurrence of perforation with resorption in tooth structure.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Operative Dentistry, University of Damascus Dental School
Damascus, DM20AM18
About this study
Official title: A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Sealing Root Perforations.
This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two materials are going to be tested in sealing accidental root perforations at the bifurcation areas. The study is going to be conducted as a randomized controlled trial.
- Conditions
- Root Perforation at the Bifurcation Area
- Being tested
- Biodentine, MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDrug
Biodentine is going to be used as the sealing agent for the perforation.
MTADrug
MTA is going to be used as the sealing agent for the perforation.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | The perforation area of the root is going to be covered by Biodentine Receives: Drug: Biodentine |
| MTA | Active comparator | The perforation area of the root is going to be covered by MTA. Receives: Drug: MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success at 3 months following root sealing
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Measured: The success of treatment is assessed at three months following the application of the material
Success at 6 months following root sealing
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Measured: The success of treatment is assessed at 6 months following the application of the material
Success at 9 months following root sealing
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Measured: The success of treatment is assessed at 9 months following the application of the material
Success at 12 months following root sealing
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Measured: The success of treatment is assessed at 12 months following the application of the material
Success at 18 months following root sealing
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Measured: The success of treatment is assessed at 18 months following the application of the material
Success at 24 months following root sealing
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Measured: The success of treatment is assessed at 24 months following the application of the material
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJan 2015
- Primary completion20 Jun 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Root Perforation at the Bifurcation AreaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad MN Aldakak, DDS MSc, Principal investigator, PhD Student in Operative DentistrySouad Abboud, DDS MSc PhD, Study chair, Associate Professor of Operative Dentistry, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805101
- Sponsor's protocol ID
- UDDS-OperDent-02-2016
- Status last verified
- Dec 2017
- First submitted
- 15 Jun 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Guneser MB, Akbulut MB, Eldeniz AU. Effect of various endodontic irrigants on the push-out bond strength of biodentine and conventional root perforation repair materials. J Endod. 2013 Mar;39(3):380-4. doi: 10.1016/j.joen.2012.11.033. Epub 2013 Jan 16.
PubMed 23402511Iwamoto CE, Adachi E, Pameijer CH, Barnes D, Romberg EE, Jefferies S. Clinical and histological evaluation of white ProRoot MTA in direct pulp capping. Am J Dent. 2006 Apr;19(2):85-90.
PubMed 16764130Koubi G, Colon P, Franquin JC, Hartmann A, Richard G, Faure MO, Lambert G. Clinical evaluation of the performance and safety of a new dentine substitute, Biodentine, in the restoration of posterior teeth - a prospective study. Clin Oral Investig. 2013 Jan;17(1):243-9. doi: 10.1007/s00784-012-0701-9. Epub 2012 Mar 14.
PubMed 22411260Laurent P, Camps J, De Meo M, Dejou J, About I. Induction of specific cell responses to a Ca(3)SiO(5)-based posterior restorative material. Dent Mater. 2008 Nov;24(11):1486-94. doi: 10.1016/j.dental.2008.02.020. Epub 2008 Apr 29.
PubMed 18448160Zanini M, Sautier JM, Berdal A, Simon S. Biodentine induces immortalized murine pulp cell differentiation into odontoblast-like cells and stimulates biomineralization. J Endod. 2012 Sep;38(9):1220-6. doi: 10.1016/j.joen.2012.04.018. Epub 2012 Jul 24.
PubMed 22892739
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Sealing Root Perforations.
- ClinicalTrials.gov ID
- NCT02805101
- Acronym / sponsor ID
- UDDS-OperDent-02-2016
- Conditions
- Root Perforation at the Bifurcation Area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two materials are going to be tested in sealing accidental root perforations at the bifurcation areas. The study is going to be conducted as a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Drug: BiodentineThe perforation area of the root is going to be covered by Biodentine |
| MTA | Active comparator | Drug: MTAThe perforation area of the root is going to be covered by MTA. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- vital molars (upper or lower )
- suffered from perforation in the bifurcation area of the roots through a process of open access cavity, taking into account the location and size of perforation
- Perforation should not exceed the size of 3 mm
- Perforation and must also take into account the time of perforation.
Key exclusion criteria (4 listed)
- If the molar not vital.
- If the perforation not in bifurcation root or extended inside the canals.
- Size of perforation larger than 3 mm.
- A long time ago on the occurrence of perforation with resorption in tooth structure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiodentineBiodentine is going to be used as the sealing agent for the perforation. | Drug | Biodentine |
| MTAMTA is going to be used as the sealing agent for the perforation. | Drug | MTA |
Primary outcome
Success at 3 months following root sealing
Time frame: The success of treatment is assessed at three months following the application of the material
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 6 months following root sealing
Time frame: The success of treatment is assessed at 6 months following the application of the material
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 9 months following root sealing
Time frame: The success of treatment is assessed at 9 months following the application of the material
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 12 months following root sealing
Time frame: The success of treatment is assessed at 12 months following the application of the material
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 18 months following root sealing
Time frame: The success of treatment is assessed at 18 months following the application of the material
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 24 months following root sealing
Time frame: The success of treatment is assessed at 24 months following the application of the material
Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Background: PubMed 23402511Guneser MB, Akbulut MB, Eldeniz AU. Effect of various endodontic irrigants on the push-out bond strength of biodentine and conventional root perforation repair materials. J Endod. 2013 Mar;39(3):380-4. doi: 10.1016/j.joen.2012.11.033. Epub 2013 Jan 16.
- Background: PubMed 16764130Iwamoto CE, Adachi E, Pameijer CH, Barnes D, Romberg EE, Jefferies S. Clinical and histological evaluation of white ProRoot MTA in direct pulp capping. Am J Dent. 2006 Apr;19(2):85-90.
- Background: PubMed 22411260Koubi G, Colon P, Franquin JC, Hartmann A, Richard G, Faure MO, Lambert G. Clinical evaluation of the performance and safety of a new dentine substitute, Biodentine, in the restoration of posterior teeth - a prospective study. Clin Oral Investig. 2013 Jan;17(1):243-9. doi: 10.1007/s00784-012-0701-9. Epub 2012 Mar 14.
- Background: PubMed 18448160Laurent P, Camps J, De Meo M, Dejou J, About I. Induction of specific cell responses to a Ca(3)SiO(5)-based posterior restorative material. Dent Mater. 2008 Nov;24(11):1486-94. doi: 10.1016/j.dental.2008.02.020. Epub 2008 Apr 29.
- Background: PubMed 22892739Zanini M, Sautier JM, Berdal A, Simon S. Biodentine induces immortalized murine pulp cell differentiation into odontoblast-like cells and stimulates biomineralization. J Endod. 2012 Sep;38(9):1220-6. doi: 10.1016/j.joen.2012.04.018. Epub 2012 Jul 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad MN Aldakak, DDS MSc principal investigator
PhD Student in Operative Dentistry
Souad Abboud, DDS MSc PhD study chair
Associate Professor of Operative Dentistry, University of Damascus Dental School, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine and MTA in people with Root Perforation at the Bifurcation Area, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success at 3 months following root sealing (time frame: The success of treatment is assessed at three months following the application of the material). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805101, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.