NCT02799927

Brief Summary

Objective: The study's main purpose is to evaluate and compare the clinical and radiographic outcomes of Biodentine and a light-activated calcium hydroxide based-liner (Ultra-Blend plus®) as indirect pulp treatment (IPT) liners, over the dentin-pulp complex of vital primary molars with carious lesions approaching the pulp. Study design: 80 four-to-eight year-old patients were enrolled from a Mexican University Pediatric Dentistry Clinic. A split-mouth design trial is being conducted in order to compare both IPT interventions on 160 bilateral primary teeth, without signs or symptoms of irreversibly inflamed or degenerative pulp tissue. Teeth were treated and restored with a preformed crown in a single session, and then closely followed-up for 1, 3, 6, 12, 18, and 24 months.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

1.4 years

First QC Date

May 19, 2016

Last Update Submit

June 14, 2016

Conditions

Dental Caries

Keywords

Indirect Pulp TreatmentPrimary TeethBiodentineCalcium HydroxideSplit-Mouth design

Outcome Measures

Primary Outcomes (1)

  • Pain. Binary variable (present/absent).

    Pain is assessed through interrogatory. It is a binary variable (pain present or pain absent)

    2 years

Secondary Outcomes (5)

  • Sensitivity to percussion. Binary variable (present/absent).

    2 years

  • Abnormal tooth mobility. Binary variable (present/absent).

    2 years

  • Soft tissues inflammation. Binary variable (present/absent).

    2 years

  • Periradicular lesions. Binary variable (present/absent).

    2 years

  • Sensitivity to palpation. Binary variable (present/absent).

    2 years

Study Arms (2)

Biodentine

EXPERIMENTAL

Biodentine (Septodont, Saint-Maur-des-Fosses, France) has been recently introduced and marketed as a bioactive dentin substitute. The Biodentine powder contains tricalcium silicate, dicalcium silicate and calcium oxide, while its liquid consists of calcium chloride and a carboxylate-based hydrosoluble polymer (water-reducing agent). After local anesthesia and rubber dam isolation, carious peripheral dentin is eliminated with a high speed tungsten-carbide bur # 3, and air-water spray. Then, the cavity's floor soft dentin layer is carefully removed with a sharply-edged sterilized hand excavator, leaving only the hard dentin adjacent to the pulp ceiling. The cavity is thoroughly rinsed only with water and dried with sterilized cotton pellets. The next step consists in the preparation of Biodentine liner (a mix of powder and liquid), following the manufacturers' instructions, and its placement over the remanent carious dentin layer.

Procedure: Indirect Pulp Treatment with Bioactive Dentin Substitute

Ultra-Blend plus (Calcium hydroxide)

ACTIVE COMPARATOR

Ultra-Blend plus® (Ultradent Products Inc., South Jordan, UT, USA). This material is a light-activated calcium hydroxide based-liner. Calcium hydroxide has demonstrated to reduce and promote immediate deactivation of the residual microorganisms after IPT. After local anesthesia and rubber dam isolation, carious peripheral dentin is eliminated with a high speed tungsten-carbide bur # 3, and air-water spray. Then, the cavity's floor soft dentin layer is carefully removed with a sharply-edged sterilized hand excavator, leaving only the hard dentin adjacent to the pulp ceiling. The cavity is thoroughly rinsed only with water and dried with sterilized cotton pellets. The next step consists in the placement of Ultra-Blend plus liner over the remanent carious dentin layer, using a dycal metallic applicator. Finally, the liner is cured through light exposure during 20 seconds .

Procedure: Indirect Pulp treatment with Calcium hydroxide

Interventions

Indirect Pulp Treatment with Bioactive Dentin SubstitutePROCEDURE

The indirect pulp treatment (IPT), with Biodentine is a vital pulp procedure for dep cariously primary teeth without carious exposure, involving the removal of the softened, humid and infected dentin layer, leaving intact intentionally the deepest layer of the dentin-pulp complex, followed by the placement of Biodentine and a hermetic restoration to provide a seal against microleakage, without the necessity to reenter for removing the residual caries.

Also known as: Biodentine
Biodentine
Indirect Pulp treatment with Calcium hydroxidePROCEDURE

The indirect pulp treatment (IPT), with Biodentine is a vital pulp procedure for dep cariously primary teeth without carious exposure, involving the removal of the softened, humid and infected dentin layer, leaving intact intentionally the deepest layer of the dentin-pulp complex, followed by the placement of Ultra-Blend plus, and a hermetic restoration to provide a seal against microleakage, without the necessity to reenter for removing the residual caries.

Also known as: Ultra-Blend plus
Ultra-Blend plus (Calcium hydroxide)

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • At least one restorable first or second primary molar in each side of the mouth, affected by an occlusal cavitated active caries lesion in deep dentin.
  • Cooperative patients.
  • Participants were included in the trial after parental acceptance through a signed informed consent.

You may not qualify if:

  • Molars with mobility, spontaneous pain or fistula, and radiographic findings such as a carious lesion with no evidence of residual dentin over the pulp chamber or manifest pulp exposition.
  • Normally internal root resorption or physiological root resorption less than 1/3.
  • Presence of periradicular/furcal radiolucent lesions.
  • Occurrence of a carious pulp exposure and bleeding during the operative procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Al-Zayer MA, Straffon LH, Feigal RJ, Welch KB. Indirect pulp treatment of primary posterior teeth: a retrospective study. Pediatr Dent. 2003 Jan-Feb;25(1):29-36.

    PMID: 12627699BACKGROUND

  • Casagrande L, Bento LW, Rerin SO, Lucas Ede R, Dalpian DM, de Araujo FB. In vivo outcomes of indirect pulp treatment using a self-etching primer versus calcium hydroxide over the demineralized dentin in primary molars. J Clin Pediatr Dent. 2008 Winter;33(2):131-5. doi: 10.17796/jcpd.33.2.82r1tp71x75m5345.

    PMID: 19358380BACKGROUND

  • Fernandes JM, Massoni AC, Ferreira JM, Menezes VA. Use of calcium hydroxide in deep cavities of primary teeth. Quintessence Int. 2013;44(6):417-23. doi: 10.3290/j.qi.a29503.

    PMID: 23534045BACKGROUND

  • Kim J, Song YS, Min KS, Kim SH, Koh JT, Lee BN, Chang HS, Hwang IN, Oh WM, Hwang YC. Evaluation of reparative dentin formation of ProRoot MTA, Biodentine and BioAggregate using micro-CT and immunohistochemistry. Restor Dent Endod. 2016 Feb;41(1):29-36. doi: 10.5395/rde.2016.41.1.29. Epub 2016 Jan 4.

    PMID: 26877988BACKGROUND

  • Petrou MA, Alhamoui FA, Welk A, Altarabulsi MB, Alkilzy M, H Splieth C. A randomized clinical trial on the use of medical Portland cement, MTA and calcium hydroxide in indirect pulp treatment. Clin Oral Investig. 2014;18(5):1383-9. doi: 10.1007/s00784-013-1107-z. Epub 2013 Sep 17.

    PMID: 24043482BACKGROUND

  • Trairatvorakul C, Sastararuji T. Indirect pulp treatment vs antibiotic sterilization of deep caries in mandibular primary molars. Int J Paediatr Dent. 2014 Jan;24(1):23-31. doi: 10.1111/ipd.12022. Epub 2013 Jan 24.

    PMID: 23346907BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

tricalcium silicateCalcium Hydroxide

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Officials

  • María S Ruiz, M. Sc.

    Pediatric Dentistry Postgraduate Program

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor/Lecturer

Study Record Dates

First Submitted

May 19, 2016

First Posted

June 15, 2016

Study Start

November 1, 2014

Primary Completion

April 1, 2016

Study Completion

November 1, 2016

Last Updated

June 16, 2016

Record last verified: 2016-06