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

• Sponsor: Universidad de los Andes, Chile (Other)
• Overall Status: Completed
• CT.gov ID: NCT02492841
• Collaborator: (none)
• Enrollment: 169
• Location: 1
• Arms: 3
• Duration (Months): 28
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Caries; Dental Pulp Exposure	Drug: Mineral trioxide aggregate; Drug: Calcium hydroxide; Drug: Biodentine	Phase 2/Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 169 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mineral trioxide aggregate (MTA) Mineral trioxide aggregate Root canal repair material	Drug: Mineral trioxide aggregate; Mineral trioxide aggregate; Other Names: MTA Pro Root
Active Comparator: Calcium hydroxide -material for pulp capping	Drug: Calcium hydroxide; Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.; Other Names: Calcium hydroxide Hertz
Experimental: Biodentine Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping	Drug: Biodentine; Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.; Other Names: Active biosilicate. Septodont.

Outcome Measures

Primary Outcome Measures

1. Treatment Outcome [3 months, 6 moths and 12 months]

   vitality test with electric device cold and hot test radiographic evaluation

Secondary Outcome Measures

1. Adverse Effects [1 week, 3 and 6 months]

   Name any adverse effects.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Salud de San Bernardo Universidad de Los Andes	Santiago		Chile

Sponsors and Collaborators

• Universidad de los Andes, Chile

Investigators

• Principal Investigator: Claudia Brizuela, Universidad de los Andes

Study Documents (Full-Text)

None provided.

More Information

Publications

• Leye Benoist F, Gaye Ndiaye F, Kane AW, Benoist HM, Farge P. Evaluation of mineral trioxide aggregate (MTA) versus calcium hydroxide cement (Dycal(®) ) 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.
• Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlińska 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.
• 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.

• Responsible Party: Dra. Claudia Brizuel, DDS, Universidad de los Andes, Chile
• ClinicalTrials.gov Identifier: NCT02492841
• Other Study ID Numbers: RPD-7-16; SA13I20175
• First Posted: Jul 9, 2015
• Last Update Posted: Aug 14, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dra. Claudia Brizuel, DDS, Universidad de los Andes, Chile: dentin substitute; vital pulp therapy; Biodentine; caries
• Additional relevant MeSH terms: Dental Pulp Exposure; Calcium, Dietary; Calcium

Study Results

Participant Flow

Arm/Group Title	Mineral Trioxide Aggregate (MTA)	Calcium Hydroxide	Biodentine
Arm/Group Description	Mineral trioxide aggregate Root canal repair material Mineral trioxide aggregate: Mineral trioxide aggregate	-material for pulp capping Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.	Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
Period Title: Overall Study
STARTED	56	53	60
COMPLETED	22	22	25
NOT COMPLETED	34	31	35

Baseline Characteristics

Arm/Group Title	Mineral Trioxide Aggregate (MTA)	Calcium Hydroxide	Biodentine	Total
Arm/Group Description	Mineral trioxide aggregate Root canal repair material Mineral trioxide aggregate: Mineral trioxide aggregate	-material for pulp capping Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.	Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.	Total of all reporting groups
Overall Participants	56	53	60	169
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.51 (2.34)	11.64 (2.65)	11.22 (2.34)	11.44 (2.44)
Sex: Female, Male (Count of Participants)
Female	29 51.8%	29 54.7%	29 48.3%	87 51.5%
Male	27 48.2%	24 45.3%	31 51.7%	82 48.5%
Tooth (Count of Participants)
Maxillary First molar	16 28.6%	11 20.8%	17 28.3%	44 26%
Maxillary Second molar	1 1.8%	0 0%	1 1.7%	2 1.2%
Mandibular First molar	32 57.1%	36 67.9%	36 60%	104 61.5%
Mandibular Second molar	7 12.5%	6 11.3%	6 10%	19 11.2%

Outcome Measures

1. Primary Outcome

Title	Treatment Outcome
Description	vitality test with electric device cold and hot test radiographic evaluation
Time Frame	3 months, 6 moths and 12 months

Outcome Measure Data

Analysis Population Description

Intent a preventive treatment against cavities to avoid endodoncies with different treatments and see which one is more effective after 12 months follow up.

Arm/Group Title	Mineral Trioxide Aggregate (MTA)	Calcium Hydroxide	Biodentine
Arm/Group Description	Mineral trioxide aggregate Root canal repair material Mineral trioxide aggregate: Mineral trioxide aggregate Three failed up to 12 months follow up. one endodontic one pulpotomy one pulp capping	-material for pulp capping Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material. Three failed up to 12 months follow up two endodontic one tooth extraction	Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution. Cero failed up to 12 months follow up
Measure Participants	22	22	25
Succesfull treatment	19 33.9%	19 35.8%	25 41.7%
Need other treatment	3 5.4%	3 5.7%	0 0%

2. Secondary Outcome

Title	Adverse Effects
Description	Name any adverse effects.
Time Frame	1 week, 3 and 6 months

Outcome Measure Data

Analysis Population Description

There were no adverse effects in the population studied.

Arm/Group Title	Mineral Trioxide Aggregate (MTA)	Calcium Hydroxide	Biodentine
Arm/Group Description	Mineral trioxide aggregate Root canal repair material Mineral trioxide aggregate: Mineral trioxide aggregate	-material for pulp capping Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.	Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
Measure Participants	22	22	25
Count of Participants [Participants]	0 0%	0 0%	0 0%

Adverse Events

Time Frame	12 months
Arm/Group Title	Mineral Trioxide Aggregate (MTA)		Calcium Hydroxide		Biodentine
Arm/Group Description	Mineral trioxide aggregate Root canal repair material Mineral trioxide aggregate: Mineral trioxide aggregate		-material for pulp capping Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.		Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
All Cause Mortality
	Mineral Trioxide Aggregate (MTA)		Calcium Hydroxide		Biodentine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		0/25 (0%)
Serious Adverse Events
	Mineral Trioxide Aggregate (MTA)		Calcium Hydroxide		Biodentine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Mineral Trioxide Aggregate (MTA)		Calcium Hydroxide		Biodentine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		0/25 (0%)

Limitations/Caveats

The small sample due to inclusion criteria. Lack of collaboration from the primary health providers. And the fact that the oral health seems not to be a priority and people only come when it hurts and it is too late for prevention.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.