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Comparison Between Biodentine and Calcium Hydroxide in the Indirect Pulp Treatment on Primary Teeth (IPT)

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ClinicalTrials.gov Identifier: NCT02799927
Recruitment Status : Unknown
Verified June 2016 by José Arturo Garrocho Rangel, Universidad Autonoma de San Luis Potosí.
Recruitment status was:  Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
José Arturo Garrocho Rangel, Universidad Autonoma de San Luis Potosí

Tracking Information
First Submitted Date  ICMJE May 19, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date June 16, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
Pain. Binary variable (present/absent). [ Time Frame: 2 years ]
Pain is assessed through interrogatory. It is a binary variable (pain present or pain absent)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Sensitivity to percussion. Binary variable (present/absent). [ Time Frame: 2 years ]
    Treated tooth is softly hit with a dental handle mirror. Sensitivity is recorded as a binary variable (present/absent).
  • Abnormal tooth mobility. Binary variable (present/absent). [ Time Frame: 2 years ]
    This variable is measured by handling the treated tooth with two fingers. It is a binary variable (present/absent).
  • Soft tissues inflammation. Binary variable (present/absent). [ Time Frame: 2 years ]
    This feature is assessed through visual examination of surrounding soft gingival tissues (texture, color, size). It is a binary variable(present/absent) .
  • Periradicular lesions. Binary variable (present/absent). [ Time Frame: 2 years ]
    These lesions are observed through radiographic examination. They appear as radiolucencies around the tooth's root (s). It is a binary variable (present/absent)
  • Sensitivity to palpation. Binary variable (present/absent). [ Time Frame: 2 years ]
    Treated tooth is softly pressed with a finger. Sensitivity is recorded as a binary variable (present/absent).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • Sensitivity to percussion. Binary variable (present/absent). [ Time Frame: 2 years ]
    Treated tooth is softly hit with a dental handle mirror. Sensitivity is recorded as a binary variable (present/absent).
  • Abnormal tooth mobility. Binary variable (present/absent). [ Time Frame: 2 years ]
    This variable is measured by handling the treated tooth with two fingers. It is complemented by the patient´s age and a radiographic examination. It is a binary variable (present/absent).
  • Soft tissues inflammation. Binary variable (present/absent). [ Time Frame: 2 years ]
    This feature is assessesed through visual examination of surrounding soft gingival tissues (texture, color, size). It is a binary variable(present/absent) .
  • Periradicular lesions. Binary variable (present/absent). [ Time Frame: 2 years ]
    These lesions are observed through radiographic examination. They appear as radiolucences around the tooth's root (s). It is a binary variable (present/absent)
  • Sensitivity to palpation. Binary variable (present/absent). [ Time Frame: 2 years ]
    Treated tooth is softly pressed with a finger. Sensitivity is recorded as a binary variable (present/absent).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Biodentine and Calcium Hydroxide in the Indirect Pulp Treatment on Primary Teeth
Official Title  ICMJE A Split-mouth Trial Comparing Biodentine and Calcium Hydroxide in the Indirect Pulp Treatment on Primary Teeth
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.
Detailed Description A Split-mouth clinical trial was the design selected. Clinical Procedures: IPT procedures were carried out by three pediatric dentistry residents (E.K.C.G., R.A.V.V., and J.M.A.R.), previously trained in the clinical setting with a pilot sample of 10 similar child patients each. Study participants received local anesthesia and rubber dam isolation, which was disinfected, followed by the remove of the carious peripheral dentin with high speed tungsten-carbide bur # 3, and air-water spray. Then, the soft dentin layer was carefully removed with a sharply-edged sterilized hand excavator, based on tactile and visual standards, leaving only the hard dentin adjacent to the pulp ceiling. The cavity was thoroughly rinsed only with water and then dried with sterilized cotton pellets; no other special disinfection protocol was applied. The next step consisted in the placement of the correspondent liner over the remanent carious dentin layer, following the manufacturers' instructions, and according to the randomly assignment scheme previously described. In the case of the control group, the liner was cured undr 20 seconds of light exposure. All treated molar were restored with stainless steel preformed crowns (3M ESPE) cemented with glass ionomer (Ketac-Cem, 3M ESPE). One week later, the same procedure was repeated in the opposite tooth with the contrary IPT agent.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Procedure: Indirect Pulp Treatment with Bioactive Dentin Substitute
    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.
    Other Name: Biodentine
  • Procedure: Indirect Pulp treatment with Calcium hydroxide
    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.
    Other Name: Ultra-Blend plus
Study Arms  ICMJE
  • Experimental: Biodentine

    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.

    Intervention: Procedure: Indirect Pulp Treatment with Bioactive Dentin Substitute
  • Active Comparator: Ultra-Blend plus (Calcium hydroxide)

    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 .

    Intervention: Procedure: Indirect Pulp treatment with Calcium hydroxide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 9, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02799927
Other Study ID Numbers  ICMJE CEI-FE-003-014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Yes. Only in case of future systematic reviews with meta-analysis.
Responsible Party José Arturo Garrocho Rangel, Universidad Autonoma de San Luis Potosí
Study Sponsor  ICMJE José Arturo Garrocho Rangel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: María S Ruiz, M. Sc. Pediatric Dentistry Postgraduate Program
PRS Account Universidad Autonoma de San Luis Potosí
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP