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Periapical DiseasesPhase 2NCT02625298

Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth

A Phase 2 study testing ProRoot MTA and MTA+ Cerkamed in people with Periapical Diseases, run by Association of Paediatric and Preventive Dentists of Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Traumatic tooth injuries are common in children and adolescents, and often result in pulpal necrosis and the development of periapical lesions. Treatment of traumatized teeth with endodontic complications depends on the type of injury, number of injured teeth, root development and patient cooperation, which altogether… Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Periapical Diseases
What is being tested?
ProRoot MTA and MTA+ Cerkamed
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Sep 2010to Mar 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 7 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy patient
  • Non-vital tooth with chronic periapical lesions
  • Restorable tooth
  • No horizontal or vertical root fractures
  • No root resorption

Who cannot join

  • Unrestorable tooth
  • Horizontal or vertical root fractures
  • Root resorption

About this study

Official title: Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Permanent Teeth With Necrotic Pulps and Chronic Periapical Lesions

Traumatic tooth injuries are common in children and adolescents, and often result in pulpal necrosis and the development of periapical lesions. Treatment of traumatized teeth with endodontic complications depends on the type of injury, number of injured teeth, root development and patient cooperation, which altogether will create a challenge and dictate the treatment plan for the dentist. The purpose of this study was to assess the effectiveness of non-surgical root canal procedures in traumatized permanent teeth with necrotic pulps and chronic periapical lesions using a tri-antibiotic paste and calcium-hydroxide as intracanal medications and two different mineral trioxide aggregate (MTA) products for definitive obturation.

Read the detailed description

Root canal procedures will be performed on single-rooted traumatized permanent teeth (both with mature and immature root development) with necrotic pulps and periaoical lesions. Following access opening in each tooth, the root canals will be gently debrided with a crown-down manual technique using K-files according to the radiographically determined working lengths; irrigation with saline was used in all cases. K-files will be only used to remove the necrotic tissue and the softened predentinal layer without excessive removal of mineralized dentin, as this may have further weaken already thin walls of the root canals, particularly those with immature apical development. Subsequently, a reshaping of the canal system, followed by a minor curettage of the periapical area through the canal using barbed broaches will be made in order to partially destruct the periapical lesion and provoke bleeding. Final irrigation will be performed using 2% NaOCl (Chloraxid, Cerkamed, Stalowa Wola-Poland), 0.2% solution of chlorhexidine-digluconate (Curasept 220, Curadent Swiss GmbH, Kriens-Switzerland) and 40% citric acid solution (40% Citric acid, Cerkamed, Stalowa Wola, Poland). The canals will be then dried with sterile paper points and filled with triple-antibiotics paste using a lentula, for a period of seven days. Following this initial disinfection, calcium-hydroxide paste will be placed into the root canals for at least four weeks, for a maximum of six weeks (UltraCal XS, Ultradent Products Inc., South Jordan, UT USA). Apical thirds of the root canals will be obturated either with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA) or MTA+ Cerkamed (Cerkamed, Stalowa Wola, Poland) by forming an apical plug of 3-5 mm of thickness. The correct placement of the apical plug will be assessed radiographically, and the moist cotton pellet was left in the root canal. The next day, the rest of the canal space will be filled with a sealer (Acroseal, Septodont, Saint-Maur des Frosses-France) and gutta-percha points (Guttapercha, VDW GmbH, Munich-Germany) using a lateral compaction technique. Coronal parts of root canal systems will be sealed using glass-ionomer cement (Fuji IX, GC Int., Tokyo, Japan) with a minimum thickness of 1.5-2 mm. The teeth will be restored using composite material (Gradia Direct, GC Int., Tokyo, Japan). Two dentists with many years of clinical experience, and using identical, predetermined treatment protocols will perform all treatments.

The positive clinical outcome will comprise of absence of spontaneous or provoked pain, no discomfort during chewing, no numbness or tenderness to percussion and/or palpation, no altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract. Radiological assessment of the outcomes will be performed according to the analysis of post treatment radiographs (initial, baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software.

Being tested
ProRoot MTA, MTA+ Cerkamed
Keywords
periapical diseases, dental injuries, MTA
Medical subject headings
Periapical Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProRoot MTADevice

    Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA).

  • MTA+ CerkamedDevice

    Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland).

Study groups in NCT02625298
Study groupRoleWhat they receive
ProRoot MTAExperimentalTraumatized permanent teeth obturated with ProRoot MTA after root canal treatment
Receives: Device: ProRoot MTA
MTA+ CercamedExperimentalTraumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
Receives: Device: MTA+ Cerkamed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes Between Initial and Post Treatment Dimensions of Periapical Lesions

    Changes in the dimensions of periapical lesions will be performed according to the analysis of initial and post treatment radiographs (baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software. Sucessful radiographic assessment will include decrease in size of the periapical lesion at the recall time of 24 months.

    Measured: baseline, 3, 6, 12 and 24 months

Secondary outcomes (1)
  1. Presence of Clinical Symptoms

    Clinical examination will be used to assess the presence of spontaneous or provoked pain, discomfort during chewing, numbness or tenderness to percussion and/or palpation, altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2015 (estimated)
  2. Study startSep 2010
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625298
Sponsor's protocol ID
001-12
Status last verified
Jul 2017
First submitted
1 Dec 2015
Last updated
27 Sep 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ProRoot MTA and MTA+ Cerkamed in people with Periapical Diseases, run by Association of Paediatric and Preventive Dentists of Serbia.

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 5 inclusion and 3 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 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Changes Between Initial and Post Treatment Dimensions of Periapical Lesions (time frame: baseline, 3, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Sep 2017.

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