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Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02625298
Enrollment
24
Registered
2015-12-09
Start date
2010-09-30
Completion date
2016-03-31
Last updated
2017-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Diseases

Keywords

periapical diseases, dental injuries, MTA

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.

Interventions

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

DEVICEMTA+ Cerkamed

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

Sponsors

Association of Paediatric and Preventive Dentists of Serbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes Between Initial and Post Treatment Dimensions of Periapical Lesionsbaseline, 3, 6, 12 and 24 monthsChanges 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

MeasureTime frameDescription
Presence of Clinical SymptomsbaselineClinical 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.

Participant flow

Recruitment details

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.

Pre-assignment details

Based on patient's subjective symptoms, clinical examination, vitality testing and analysis of periapical radiograph, the acute exacerbation of a necrotic pulp with chronic apical periodontitis was diagnosed. If the teeth were unrestorable or with signs of horizontal or vertical root fractures or root resorption, they were excluded from this study.

Participants by arm

ArmCount
ProRoot MTA
Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA).
11
ProRoot MTA
Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment ProRoot MTA: Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA).
14
MTA+ Cercamed
Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland).
13
MTA+ Cercamed
Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment MTA+ Cerkamed: Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland).
13
Total51

Baseline characteristics

CharacteristicProRoot MTAMTA+ CercamedTotal
Age, Categorical
<=18 years
14 tooth13 tooth27 tooth
Age, Categorical
>=65 years
0 tooth0 tooth0 tooth
Age, Categorical
Between 18 and 65 years
0 tooth0 tooth0 tooth
Region of Enrollment
Serbia
14 tooth13 tooth27 tooth
Sex: Female, Male
Female
6 Participants7 Participants13 Participants
Sex: Female, Male
Male
5 Participants6 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 110 / 13
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
ProRoot MTAChanges Between Initial and Post Treatment Dimensions of Periapical LesionsInitial37.34 square millimetersStandard Deviation 0.63
ProRoot MTAChanges Between Initial and Post Treatment Dimensions of Periapical LesionsBaseline16.20 square millimetersStandard Deviation 0.21
ProRoot MTAChanges Between Initial and Post Treatment Dimensions of Periapical Lesions3 months12.74 square millimetersStandard Deviation 0.19
ProRoot MTAChanges Between Initial and Post Treatment Dimensions of Periapical Lesions6 months11.59 square millimetersStandard Deviation 0.25
ProRoot MTAChanges Between Initial and Post Treatment Dimensions of Periapical Lesions12 months8.38 square millimetersStandard Deviation 0.1
ProRoot MTAChanges Between Initial and Post Treatment Dimensions of Periapical Lesions24 months2.99 square millimetersStandard Deviation 0.1
MTA+ CercamedChanges Between Initial and Post Treatment Dimensions of Periapical Lesions12 months4.85 square millimetersStandard Deviation 0.24
MTA+ CercamedChanges Between Initial and Post Treatment Dimensions of Periapical LesionsInitial34.04 square millimetersStandard Deviation 0.34
MTA+ CercamedChanges Between Initial and Post Treatment Dimensions of Periapical Lesions6 months7.86 square millimetersStandard Deviation 0.23
MTA+ CercamedChanges Between Initial and Post Treatment Dimensions of Periapical LesionsBaseline17.54 square millimetersStandard Deviation 0.75
MTA+ CercamedChanges Between Initial and Post Treatment Dimensions of Periapical Lesions24 months2.48 square millimetersStandard Deviation 0.1
MTA+ CercamedChanges Between Initial and Post Treatment Dimensions of Periapical Lesions3 months12.01 square millimetersStandard Deviation 0.34
p-value: <0.01Mixed Models Analysis
Secondary

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

ArmMeasureGroupValue (NUMBER)
ProRoot MTAPresence of Clinical Symptomsnumbness3 participants
ProRoot MTAPresence of Clinical Symptomsaltered tooth mobility2 participants
ProRoot MTAPresence of Clinical Symptomsdiscomfort during chewing8 participants
ProRoot MTAPresence of Clinical Symptomstooth crown discoloration1 participants
ProRoot MTAPresence of Clinical Symptomstenderness to percussion and/or palpation2 participants
ProRoot MTAPresence of Clinical Symptomsabscess and/or sinus tract1 participants
ProRoot MTAPresence of Clinical Symptomsspontaneous or provoked pain5 participants
MTA+ CercamedPresence of Clinical Symptomsabscess and/or sinus tract0 participants
MTA+ CercamedPresence of Clinical Symptomsspontaneous or provoked pain5 participants
MTA+ CercamedPresence of Clinical Symptomsdiscomfort during chewing6 participants
MTA+ CercamedPresence of Clinical Symptomsnumbness1 participants
MTA+ CercamedPresence of Clinical Symptomstenderness to percussion and/or palpation2 participants
MTA+ CercamedPresence of Clinical Symptomsaltered tooth mobility1 participants
MTA+ CercamedPresence of Clinical Symptomstooth crown discoloration1 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026