Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth
Primary Purpose
Periapical Diseases
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ProRoot MTA
MTA+ Cerkamed
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Diseases focused on measuring periapical diseases, dental injuries, MTA
Eligibility Criteria
Inclusion Criteria:
- Healthy patient
- Non-vital tooth with chronic periapical lesions
- Restorable tooth
- No horizontal or vertical root fractures
- No root resorption
Exclusion Criteria:
- Unrestorable tooth
- Horizontal or vertical root fractures
- Root resorption
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ProRoot MTA
MTA+ Cercamed
Arm Description
Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02625298
First Posted
December 1, 2015
Last Updated
August 30, 2017
Sponsor
Association of Paediatric and Preventive Dentists of Serbia
1. Study Identification
Unique Protocol Identification Number
NCT02625298
Brief Title
Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth
Official Title
Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Permanent Teeth With Necrotic Pulps and Chronic Periapical Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Association of Paediatric and Preventive Dentists of Serbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Diseases
Keywords
periapical diseases, dental injuries, MTA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProRoot MTA
Arm Type
Experimental
Arm Description
Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
Arm Title
MTA+ Cercamed
Arm Type
Experimental
Arm Description
Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
Intervention Type
Device
Intervention Name(s)
ProRoot MTA
Intervention Description
Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA).
Intervention Type
Device
Intervention Name(s)
MTA+ Cerkamed
Intervention Description
Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland).
Primary Outcome Measure Information:
Title
Changes Between Initial and Post Treatment Dimensions of Periapical Lesions
Description
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
Secondary Outcome Measure Information:
Title
Presence of Clinical Symptoms
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy patient
Non-vital tooth with chronic periapical lesions
Restorable tooth
No horizontal or vertical root fractures
No root resorption
Exclusion Criteria:
Unrestorable tooth
Horizontal or vertical root fractures
Root resorption
12. IPD Sharing Statement
Learn more about this trial
Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth
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