Clinical trial NCT03786302: Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth
Official title: Comparison of the Regenerative Ability of Tailored Amorphous Multiporous Bioglass and Biodentine in Pulpotomized Primary Teeth
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulpotomy
Keywords: TAMP BG
Biodentine
Regenerative materials
pulp therapy
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2018-12-26
Enrollment: 102
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study group (assigned to TAMP bioglass), and Control group (assigned to Biodentine ™).
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Absence of clinical signs of pulp degeneration.
timeFrame: 1 month postoperatively
measure: Percentage of Teeth with no clinical signs of pulp degeneration.
timeFrame: 3 months postoperatively
measure: Percentage of Teeth with no clinical signs of pulp degeneration.
timeFrame: 6 months postoperatively
measure: Percentage of Teeth with no clinical signs of pulp degeneration.
timeFrame: 9 months postoperatively
measure: Percentage of Teeth with no clinical signs of pulp degeneration.
timeFrame: 12 months postoperatively
measure: Percentage of Teeth with no radiographic signs of pulp degeneration.
timeFrame: 6 months postoperatively
measure: Percentage of Teeth with no radiographic signs of pulp degeneration.
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Percentage of teeth with radiographic evidence of dentin bridge formation
timeFrame: 6 months postoperatively
measure: Percentage of teeth with radiographic evidence of dentin bridge formation
timeFrame: 12 months postoperatively
measure: Dentin bridge formation using light microscopy
timeFrame: 6 weeks
measure: Inflammatory response using light microscopy
timeFrame: 6 weeks
measure: The Enzyme-Linked Immunosorbent Assay (ELISA) analysis.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Yasmine I El-Hamouly, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Karin ML Dowidar, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Samia Soliman, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Dalia AM Talaat, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Rania M El Backly, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.