Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth

Caries Clinical Trial

Official title:

Controlled Clinical Trial of the Effect of Calcium Hydroxide, Mineral Trioxide Aggregate (MTA) and Biodentine (Trademark) as Direct Pulp Capping Materials of Permanent Teeth Affected by Caries, in Children From 7 to 16 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492841
• Other study ID #: RPD-7-16
• Secondary ID: SA13I20175
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2014
• Est. completion date: August 2016

Study information

• Verified date: May 2024
• Source: Universidad de los Andes, Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation.

Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.

Description:

Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

• Systemically healthy patients

• Patients with at least one full or partial tooth root development

• Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis

• Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration

• Teeth that have pulp exposure not exceeding 1 mm in size.

Exclusion Criteria:

• Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic

• Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .

Related Conditions & MeSH terms

• Caries
• Dental Pulp Exposure

Intervention

Drug:
• Mineral trioxide aggregate
Mineral trioxide aggregate
• Calcium hydroxide
Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
• Biodentine
Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.

Locations

Country	Name	City	State
Chile	Centro de Salud de San Bernardo Universidad de Los Andes	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de los Andes, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (3)

Leye Benoist F, Gaye Ndiaye F, Kane AW, Benoist HM, Farge P. Evaluation of mineral trioxide aggregate (MTA) versus calcium hydroxide cement (Dycal((R)) ) in the formation of a dentine bridge: a randomised controlled trial. Int Dent J. 2012 Feb;62(1):33-9. doi: 10.1111/j.1875-595X.2011.00084.x. — View Citation

Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10. — View Citation

Paranjpe A, Zhang H, Johnson JD. Effects of mineral trioxide aggregate on human dental pulp cells after pulp-capping procedures. J Endod. 2010 Jun;36(6):1042-7. doi: 10.1016/j.joen.2010.02.013. Epub 2010 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters Evaluated After Treatment	vitality test with electric device cold and hot test radiographic evaluation	3 months, 6 moths and 12 months
Secondary	Number of Participants With Adverse Effects	Name any adverse effects caused by treatment.	1 week, 3 and 6 months