Trial Outcomes & Findings for Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth (NCT NCT02625298)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

baseline, 3, 6, 12 and 24 months

Results posted on

2017-09-27

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	11	13
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ProRoot MTA n=14 tooth 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).	MTA+ Cercamed n=13 tooth 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).	Total n=27 tooth Total of all reporting groups
Age, Categorical <=18 years	14 tooth n=51 tooth	13 tooth n=40 tooth	27 tooth n=39 tooth
Age, Categorical Between 18 and 65 years	0 tooth n=51 tooth	0 tooth n=40 tooth	0 tooth n=39 tooth
Age, Categorical >=65 years	0 tooth n=51 tooth	0 tooth n=40 tooth	0 tooth n=39 tooth
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Serbia	14 tooth n=51 tooth	13 tooth n=40 tooth	27 tooth n=39 tooth

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	ProRoot MTA n=11 Participants 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).	MTA+ Cercamed n=13 tooth 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).
Changes Between Initial and Post Treatment Dimensions of Periapical Lesions Initial	37.34 square millimeters Standard Deviation 0.63	34.04 square millimeters Standard Deviation 0.34
Changes Between Initial and Post Treatment Dimensions of Periapical Lesions Baseline	16.20 square millimeters Standard Deviation 0.21	17.54 square millimeters Standard Deviation 0.75
Changes Between Initial and Post Treatment Dimensions of Periapical Lesions 3 months	12.74 square millimeters Standard Deviation 0.19	12.01 square millimeters Standard Deviation 0.34
Changes Between Initial and Post Treatment Dimensions of Periapical Lesions 6 months	11.59 square millimeters Standard Deviation 0.25	7.86 square millimeters Standard Deviation 0.23
Changes Between Initial and Post Treatment Dimensions of Periapical Lesions 12 months	8.38 square millimeters Standard Deviation 0.10	4.85 square millimeters Standard Deviation 0.24
Changes Between Initial and Post Treatment Dimensions of Periapical Lesions 24 months	2.99 square millimeters Standard Deviation 0.10	2.48 square millimeters Standard Deviation 0.10

SECONDARY outcome

Timeframe: baseline

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.

Outcome measures

Outcome measures
Measure	ProRoot MTA n=11 Participants 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).	MTA+ Cercamed n=13 Participants 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).
Presence of Clinical Symptoms spontaneous or provoked pain	5 participants	5 participants
Presence of Clinical Symptoms numbness	3 participants	1 participants
Presence of Clinical Symptoms tenderness to percussion and/or palpation	2 participants	2 participants
Presence of Clinical Symptoms altered tooth mobility	2 participants	1 participants
Presence of Clinical Symptoms tooth crown discoloration	1 participants	1 participants
Presence of Clinical Symptoms discomfort during chewing	8 participants	6 participants
Presence of Clinical Symptoms abscess and/or sinus tract	1 participants	0 participants

Adverse Events

ProRoot MTA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MTA+ Cercamed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dejan Markovic, professor at Clinic for Pediatric and Preventive Dentistry

Faculty of Dentistry, University of Belgrade

Phone: +381600203041

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place