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Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth

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ClinicalTrials.gov Identifier: NCT03786302
Recruitment Status : Terminated (Failure rate was 100% in one arm of the study (the intervention))
First Posted : December 25, 2018
Last Update Posted : December 27, 2018
Sponsor:
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Nourhan M.Aly, University of Alexandria

Brief Summary:
The aim of this study was to assess clinically, radiographically, and histologically the regenerative ability of Tailored Amorphous Mulioporous (TAMP-BG) bioglass in comparison to Biodentine™ (BD) in pulpotomized primary teeth.

Condition or disease Intervention/treatment Phase
Pulpotomy Drug: TAMP bioglass Drug: Biodentine Phase 2

Detailed Description:
The study was a parallel design, randomized controlled clinical trial It was conducted in the out-patient clinic of the Pediatric Dentistry and Dental public health department after obtaining the guardians consent. The sample size was calculated to be 35 teeth per group. The teeth were randomly and equally assigned to either BD or TAMP-BG groups.The treatment follow-up was scheduled at 1, 3, 6, 9 and 12 months. The study was terminated for ethical considerations after showing significant clinical failure in the TAMP-BG group and after performing interim analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study group (assigned to TAMP bioglass), and Control group (assigned to Biodentine ™).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The operator will not be blinded to the treatment type. However, the participants, their care givers, the expert assessing the histologic and inflammatory changes and the statistician will be blinded to the treatment groups.
Primary Purpose: Treatment
Official Title: Comparison of the Regenerative Ability of Tailored Amorphous Multiporous Bioglass and Biodentine in Pulpotomized Primary Teeth
Actual Study Start Date : December 6, 2016
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : October 20, 2018

Arm Intervention/treatment
Experimental: TAMP bioglass
Tailored amorphous multiporous bioglass (TAMP-BG) of 70% SiO2 / 30% CaO was prepared according to Wang et al. (2011, 2013) in the tissue engineering lab, Faculty of Dentistry, Alexandria University as follows: Scaffolds were grounded to 180- to 300-μm particle size and sterilized at 180°C for 2 hours. The resulting powder was mixed with distilled water to obtain a putty like consistency that was carried to the pulp chamber and condensed lightly on the pulp stumps.
Drug: TAMP bioglass
TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
Other Name: TAMP BG

Active Comparator: Biodentine ™
Biodentine ™ (BD) pre-dosed capsule were gently tapped on a hard surface to diffuse the powder. Five drops of the liquid from the single dose dispenser were poured into the capsule and mixed for 30 seconds at 4,200 rpm in an amalgamator according to manufacturer's instructions to obtain putty- like consistency. (Powder-liquid system). It was then be carried to the pulp chamber and condensed lightly on the pulp stumps. Final restoration was applied after 12 minutes, allowing Biodentine ™ to set.
Drug: Biodentine
TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth




Primary Outcome Measures :
  1. Absence of clinical signs of pulp degeneration. [ Time Frame: 1 month postoperatively ]
    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  2. Percentage of Teeth with no clinical signs of pulp degeneration. [ Time Frame: 3 months postoperatively ]
    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  3. Percentage of Teeth with no clinical signs of pulp degeneration. [ Time Frame: 6 months postoperatively ]
    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  4. Percentage of Teeth with no clinical signs of pulp degeneration. [ Time Frame: 9 months postoperatively ]
    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  5. Percentage of Teeth with no clinical signs of pulp degeneration. [ Time Frame: 12 months postoperatively ]
    Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  6. Percentage of Teeth with no radiographic signs of pulp degeneration. [ Time Frame: 6 months postoperatively ]
    Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening

  7. Percentage of Teeth with no radiographic signs of pulp degeneration. [ Time Frame: 12 months postoperatively ]
    Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening


Secondary Outcome Measures :
  1. Percentage of teeth with radiographic evidence of dentin bridge formation [ Time Frame: 6 months postoperatively ]
    Assessed using digital radiographs

  2. Percentage of teeth with radiographic evidence of dentin bridge formation [ Time Frame: 12 months postoperatively ]
    Assessed using digital radiographs



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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children free of any systemic disease or special health care needs.
  • Children not receiving any anti-inflammatory medication.
  • Cooperative children (positive/ definitely positive) according to Frankl's behavior rating scale.
  • Restorable teeth.
  • Teeth with vital carious pulp exposure that will bleed upon entering the pulp chamber and not requiring more than 5 minutes to achieve hemostasis after coronal pulp amputation.
  • Teeth indicated for extraction for orthodontic purposes with the previously mentioned criteria (required for a subgroup for assessment of histological and inflammatory response outcomes).

Exclusion Criteria:

  • Teeth with clinical or radiographic signs of pulp degeneration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786302


Sponsors and Collaborators
Nourhan M.Aly
Alexandria University
Investigators
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Principal Investigator: Yasmine I El-Hamouly, MSc Alexandria University
Study Director: Karin ML Dowidar, PhD Alexandria University
Study Director: Samia Soliman, PhD Alexandria University
Study Director: Dalia AM Talaat, PhD Alexandria University
Study Director: Rania M El Backly, PhD Alexandria University

Publications:
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Responsible Party: Nourhan M.Aly, Clinical Instructor, University of Alexandria
ClinicalTrials.gov Identifier: NCT03786302     History of Changes
Other Study ID Numbers: Bioglass in pulpotomized teeth
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Nourhan M.Aly, University of Alexandria:
TAMP BG
Biodentine
Regenerative materials
pulp therapy