Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth

NCT03786302 | Terminated Phase 2

• 1 other identifier: Bioglass in pulpotomized teeth
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpotomy

Keywords

TAMP BG; Biodentine; Regenerative materials; pulp therapy

Outcome Measures

Primary Outcomes (7)

• Absence of clinical signs of pulp degeneration.

  Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  1 month postoperatively

• Percentage of Teeth with no clinical signs of pulp degeneration.

  Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  3 months postoperatively

• Percentage of Teeth with no clinical signs of pulp degeneration.

  Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  6 months postoperatively

• Percentage of Teeth with no clinical signs of pulp degeneration.

  Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  9 months postoperatively

• Percentage of Teeth with no clinical signs of pulp degeneration.

  Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility

  12 months postoperatively

• Percentage of Teeth with no radiographic signs of pulp degeneration.

  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

  6 months postoperatively

• Percentage of Teeth with no radiographic signs of pulp degeneration.

  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

  12 months postoperatively

Secondary Outcomes (5)

• Percentage of teeth with radiographic evidence of dentin bridge formation

  6 months postoperatively

• Percentage of teeth with radiographic evidence of dentin bridge formation

  12 months postoperatively

• Dentin bridge formation using light microscopy

  6 weeks

• Inflammatory response using light microscopy

  6 weeks

• The Enzyme-Linked Immunosorbent Assay (ELISA) analysis.

  6 weeks

Study Arms (2)

TAMP bioglass

EXPERIMENTAL

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

Biodentine ™

ACTIVE COMPARATOR

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

Interventions

TAMP bioglass DRUG

TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth

Also known as: 70S30C bioglass

TAMP bioglass

Biodentine DRUG

TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth

Biodentine ™

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Teeth with clinical or radiographic signs of pulp degeneration.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (6)

• Wang S, Falk MM, Rashad A, Saad MM, Marques AC, Almeida RM, Marei MK, Jain H. Evaluation of 3D nano-macro porous bioactive glass scaffold for hard tissue engineering. J Mater Sci Mater Med. 2011 May;22(5):1195-203. doi: 10.1007/s10856-011-4297-4. Epub 2011 Mar 29.

  PMID: 21445655 BACKGROUND

• Wang S, Kowal TJ, Marei MK, Falk MM, Jain H. Nanoporosity significantly enhances the biological performance of engineered glass tissue scaffolds. Tissue Eng Part A. 2013 Jul;19(13-14):1632-40. doi: 10.1089/ten.TEA.2012.0585. Epub 2013 Mar 26.

  PMID: 23427819 BACKGROUND

• Stanley HR, Clark AE, Pameijer CH, Louw NP. Pulp capping with a modified bioglass formula (#A68-modified). Am J Dent. 2001 Aug;14(4):227-32.

  PMID: 11699742 BACKGROUND

• Horsted P, El Attar K, Langeland K. Capping of monkey pulps with Dycal and a Ca-eugenol cement. Oral Surg Oral Med Oral Pathol. 1981 Nov;52(5):531-53. doi: 10.1016/0030-4220(81)90366-2.

  PMID: 6946381 BACKGROUND

• Shayegan A, Jurysta C, Atash R, Petein M, Abbeele AV. Biodentine used as a pulp-capping agent in primary pig teeth. Pediatr Dent. 2012 Nov-Dec;34(7):e202-8.

  PMID: 23265156 BACKGROUND

• Elhamouly Y, El Backly RM, Talaat DM, Omar SS, El Tantawi M, Dowidar KML. Tailored 70S30C Bioactive glass induces severe inflammation as pulpotomy agent in primary teeth: an interim analysis of a randomised controlled trial. Clin Oral Investig. 2021 Jun;25(6):3775-3787. doi: 10.1007/s00784-020-03707-5. Epub 2021 Jan 6.

  PMID: 33409691 DERIVED

MeSH Terms

Interventions

tricalcium silicate

Study Officials

• Yasmine I El-Hamouly, MSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: Study group (assigned to TAMP bioglass), and Control group (assigned to Biodentine ™).

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 26, 2018
• Study Start: December 6, 2016
• Primary Completion: August 15, 2018
• Study Completion: October 20, 2018
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

EG (1)