A Phase 2 interventional study of ProRoot MTA and MTA+ Cerkamed in Periapical Diseases, sponsored by Association of Paediatric and Preventive Dentists of Serbia. Completed. Open to participants aged 7 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-27.
Sponsored by Association of Paediatric and Preventive Dentists of Serbia · Phase 2, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Periapical Diseases; 12 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 35 interventional studies indexed under Periapical Diseases.
Browse Periapical Diseases studies →Association of Paediatric and Preventive Dentists of Serbia is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
Device: ProRoot MTA
Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
Device: MTA+ Cerkamed
Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA).
Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland).
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.
Time frame: baseline, 3, 6, 12 and 24 months
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.
Time frame: baseline
The study involved twenty-four patients, 11 males (45.8%) and 13 females (54.2%) (mean age 13.30±2.83), who came to the University Clinic, due to spontaneous or provoked pain, discomfort during chewing, numbness, and observed swelling.
| Milestone | ProRoot MTA | MTA+ Cercamed |
|---|---|---|
| Started | 11 | 13 |
| Completed | 10 | 13 |
| Not completed | 1 | 0 |
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.
| square millimeters | ProRoot MTA | MTA+ Cercamed |
|---|---|---|
| Initial | 37.34 ± 0.63 | 34.04 ± 0.34 |
| Baseline | 16.20 ± 0.21 | 17.54 ± 0.75 |
| 3 months | 12.74 ± 0.19 | 12.01 ± 0.34 |
| 6 months | 11.59 ± 0.25 | 7.86 ± 0.23 |
| 12 months | 8.38 ± 0.10 | 4.85 ± 0.24 |
| 24 months | 2.99 ± 0.10 | 2.48 ± 0.10 |
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.
| participants | ProRoot MTA | MTA+ Cercamed |
|---|---|---|
| spontaneous or provoked pain | 5 | 5 |
| discomfort during chewing | 8 | 6 |
| numbness | 3 | 1 |
| tenderness to percussion and/or palpation | 2 | 2 |
| altered tooth mobility | 2 | 1 |
| tooth crown discoloration | 1 | 1 |
| abscess and/or sinus tract | 1 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ProRoot MTA | — | — | 0/11 (0%) |
| MTA+ Cercamed | — | — | 0/13 (0%) |
| Age, Categorical(tooth) | ProRoot MTA | MTA+ Cercamed | Total |
|---|---|---|---|
| <=18 years | 14 | 13 | 27 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | ProRoot MTA | MTA+ Cercamed | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 5 | 6 | 11 |
| Region of Enrollment(tooth) | ProRoot MTA | MTA+ Cercamed | Total |
|---|---|---|---|
| Serbia | 14 | 13 | 27 |
No study locations are listed for this record.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Association of Paediatric and Preventive Dentists of Serbia