Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth

NCT02625298 | Completed Phase 2 Results DMC

• 1 other identifier: 001-12
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periapical Diseases

Keywords

periapical diseases; dental injuries; MTA

Outcome Measures

Primary Outcomes (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.

  baseline, 3, 6, 12 and 24 months

Secondary Outcomes (1)

• Presence of Clinical Symptoms

  baseline

Study Arms (2)

ProRoot MTA

EXPERIMENTAL

Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment

Device: ProRoot MTA

MTA+ Cercamed

EXPERIMENTAL

Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment

Device: MTA+ Cerkamed

Interventions

ProRoot MTA DEVICE

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

ProRoot MTA

MTA+ Cerkamed DEVICE

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

MTA+ Cercamed

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Association of Paediatric and Preventive Dentists of Serbia: lead

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Results Point of Contact

• Title: Dr. Dejan Markovic, professor at Clinic for Pediatric and Preventive Dentistry
• Organization: Faculty of Dentistry, University of Belgrade

dejan.markovic@stomf.bg.ac.rs

+381600203041

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 9, 2015
• Study Start: September 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: September 27, 2017
• Results First Posted: July 25, 2017

Record last verified: 2017-07