Apical PeriodontitisNCT03743987
The Effect of MTA and PRF Application in Periapical Lesions
A study testing MTA group, PRF group and MTA + PRF group in people with Apical Periodontitis and Wound Heal, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
A total of 40 periapical lesions from the 33 patient undergoing apical surgery were randomly selected from December 2016-November 2017. Patients were informed about the surgical procedure and signed a consent form. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Wound Heal
- What is being tested?
- MTA group, PRF group and MTA + PRF group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2016to 5 Nov 2018
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single rooted canals
- Failed previous root canal treatment
- Retreatment at least 1 year previously
- Previous surgery with unresolved bony lesion
Who cannot join
- More than single rooted canals
- Chronic generalized periodontitis
- Any systemic disease contraindicating oral surgical procedures
- Evidence of root fracture
- Resorptive processes involving more than apical third of the root
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Bone Healing After MTA and PRF Application in Periapical Lesions By Using CBCT
A total of 40 periapical lesions from the 33 patient undergoing apical surgery were randomly selected from December 2016-November 2017. Patients were informed about the surgical procedure and signed a consent form. Groups were divided in to 4; as control, MTA (mineral trioxide aggregate), PRF (platelet rich fibrin) and MTA+PRF groups. Apical resection was performed in all groups. No other interventions were made to the control group.
Routine radiographs were taken in the 1st. 3th and 6th months. In the (approximately) 12th month of the procedures computerized tomography scans were taken. Primary healing of the periapical tissues were evaluated and the outcomes were measured. Patients have still been under control for the long term outcomes of the study.
Read the detailed description
44 apically infected periapical lesions were decided to enroll to the study from December 2016-November 2017. However; a total of 40 periapical lesions undergoing apical surgery were recruited for the planned clinical trial in the end. The study was conducted under randomized controlled protocol. Patients were informed about the surgical procedures and signed a consent form. The anticipated outcomes, possible risks and benefits of the study as well as the alternative treatment options were explained to the patients.
Groups were designed to have 10 patients in each and randomly divided into four as; control, MTA, PRF and MTA+PRF. Apical resection was performed in all groups. No other interventions were made to the control group.
Routine radiographs were taken in the 1st. 3th and 6th months. In the 12th month of the procedures computerized tomography (CT) scans were taken. Primary healing of the periapical tissues were evaluated according to the volumes and the densities of the lesions. Outcomes were measured. Comparison between the initial and the last 3D CT scan volumes were made by medical image processing software (MIMICS, Belgium). Patients have still been under control for the long term outcomes of the study.
- Conditions
- Apical Periodontitis, Wound Heal
- Being tested
- control group, MTA group, PRF group, MTA + PRF group
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupProcedure or surgery
Also called root resection
a procedure used to prevent or resolves apical periodontitis.
MTA groupProcedure or surgery
Also called mineral trioxide aggregate
a procedure used to prevent or resolves apical periodontitis.
PRF groupProcedure or surgery
Also called platelet rich fibrin
a procedure that is used for wound healing
MTA + PRF groupProcedure or surgery
Also called mineral trioxide aggregate + mineral trioxide aggregate
a procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | Apical resection group. Only root resection was applied without any other interventions (like prf or mta) Receives: Procedure: control group |
| MTA group | Experimental | Root resection was applied and MTA was inserted through the apical foramen Receives: Procedure: MTA group |
| PRF group | Experimental | Root resection was applied and PRF was placed to the surgically prepared area Receives: Procedure: PRF group |
| MTA + PRF group | Experimental | Root resection was applied. MTA was inserted through the apical foramen and PRF was placed to the surgically prepared area Receives: Procedure: MTA + PRF group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic success - in volume
Evaluation of tomographic outcomes (differences between preoperative and postoperative volume of periapical lesions)
Measured: 1 year
Radiographic success - in density
Evaluation of tomographic outcomes (differences between preoperative and postoperative density of periapical lesions)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start20 Dec 2016
- Primary completion5 Nov 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazife Begüm KARAN, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Nazife Begüm KARAN, PhD, DDS, Principal investigator, Recep Tayyip Erdogan UniversityBanu Arıcıoğlu, PhD, DDS, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743987
- Sponsor's protocol ID
- RTEU 107
- Status last verified
- Feb 2019
- First submitted
- 14 Nov 2018
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data can be available 6 months after the acceptance of the paper
Publications
Karan NB, Aricioglu B. Assessment of bone healing after mineral trioxide aggregate and platelet-rich fibrin application in periapical lesions using cone-beam computed tomographic imaging. Clin Oral Investig. 2020 Feb;24(2):1065-1072. doi: 10.1007/s00784-019-03003-x. Epub 2019 Jul 18.
PubMed 31321573
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Healing After MTA and PRF Application in Periapical Lesions By Using CBCT
- ClinicalTrials.gov ID
- NCT03743987
- Acronym / sponsor ID
- RTEU 107
- Conditions
- Apical Periodontitis, Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 16 Nov 2018 (actual)
- 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.
A total of 40 periapical lesions from the 33 patient undergoing apical surgery were randomly selected from December 2016-November 2017. Patients were informed about the surgical procedure and signed a consent form. Groups were divided in to 4; as control, MTA (mineral trioxide aggregate), PRF (platelet rich fibrin) and MTA+PRF groups. Apical resection was performed in all groups. No other interventions were made to the control group.
Routine radiographs were taken in the 1st. 3th and 6th months. In the (approximately) 12th month of the procedures computerized tomography scans were taken. Primary healing of the periapical tissues were evaluated and the outcomes were measured. Patients have still been under control for the long term outcomes of the study.
Detailed description
44 apically infected periapical lesions were decided to enroll to the study from December 2016-November 2017. However; a total of 40 periapical lesions undergoing apical surgery were recruited for the planned clinical trial in the end. The study was conducted under randomized controlled protocol. Patients were informed about the surgical procedures and signed a consent form. The anticipated outcomes, possible risks and benefits of the study as well as the alternative treatment options were explained to the patients.
Groups were designed to have 10 patients in each and randomly divided into four as; control, MTA, PRF and MTA+PRF. Apical resection was performed in all groups. No other interventions were made to the control group.
Routine radiographs were taken in the 1st. 3th and 6th months. In the 12th month of the procedures computerized tomography (CT) scans were taken. Primary healing of the periapical tissues were evaluated according to the volumes and the densities of the lesions. Outcomes were measured. Comparison between the initial and the last 3D CT scan volumes were made by medical image processing software (MIMICS, Belgium). Patients have still been under control for the long term outcomes of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Procedure: control groupApical resection group. Only root resection was applied without any other interventions (like prf or mta) |
| MTA group | Experimental | Procedure: MTA groupRoot resection was applied and MTA was inserted through the apical foramen |
| PRF group | Experimental | Procedure: PRF groupRoot resection was applied and PRF was placed to the surgically prepared area |
| MTA + PRF group | Experimental | Procedure: MTA + PRF groupRoot resection was applied. MTA was inserted through the apical foramen and PRF was placed to the surgically prepared area |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Single rooted canals
- Failed previous root canal treatment
- Retreatment at least 1 year previously
- Previous surgery with unresolved bony lesion
Key exclusion criteria (5 listed)
- More than single rooted canals
- Chronic generalized periodontitis
- Any systemic disease contraindicating oral surgical procedures
- Evidence of root fracture
- Resorptive processes involving more than apical third of the root
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 |
|---|---|---|
| control groupAlso: root resectiona procedure used to prevent or resolves apical periodontitis. | Procedure or surgery | control group |
| MTA groupAlso: mineral trioxide aggregatea procedure used to prevent or resolves apical periodontitis. | Procedure or surgery | MTA group |
| PRF groupAlso: platelet rich fibrina procedure that is used for wound healing | Procedure or surgery | PRF group |
| MTA + PRF groupAlso: mineral trioxide aggregate + mineral trioxide aggregatea procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing. | Procedure or surgery | MTA + PRF group |
Primary outcome
Radiographic success - in volume
Time frame: 1 year
Evaluation of tomographic outcomes (differences between preoperative and postoperative volume of periapical lesions)
Radiographic success - in density
Time frame: 1 year
Evaluation of tomographic outcomes (differences between preoperative and postoperative density of periapical lesions)
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 25 Feb 2019.
- Derived from this study: PubMed 31321573Karan NB, Aricioglu B. Assessment of bone healing after mineral trioxide aggregate and platelet-rich fibrin application in periapical lesions using cone-beam computed tomographic imaging. Clin Oral Investig. 2020 Feb;24(2):1065-1072. doi: 10.1007/s00784-019-03003-x. Epub 2019 Jul 18.
- Individual participant dataSharing planned: No. data can be available 6 months after the acceptance of the paper
Related trials for Apical Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
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.
Nazife Begüm KARAN, PhD, DDS principal investigator
Recep Tayyip Erdogan University
Banu Arıcıoğlu, PhD, DDS principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTA group, PRF group and MTA + PRF group in people with Apical Periodontitis and Wound Heal, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 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 25 Feb 2019. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Radiographic success - in volume (time frame: 1 year). The study lists 2 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 NCT03743987, which also lists 1 linked publication.
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 25 Feb 2019.