Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth

Pulpotomy Clinical Trial

Official title:

Comparison of the Regenerative Ability of Tailored Amorphous Multiporous Bioglass and Biodentine in Pulpotomized Primary Teeth

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03786302
• Other study ID #: Bioglass in pulpotomized teeth
• Status: Terminated
• Phase: Phase 2
• Start date: December 6, 2016
• Est. completion date: October 20, 2018

Study information

• Verified date: October 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: October 20, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpotomy

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Hørsted 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of teeth with radiographic evidence of dentin bridge formation	Assessed using digital radiographs	6 months postoperatively
Secondary	Percentage of teeth with radiographic evidence of dentin bridge formation	Assessed using digital radiographs	12 months postoperatively
Secondary	Dentin bridge formation using light microscopy	After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria.; 0= No hard tissue formation.; Incomplete hard tissue formation.; Thick hard tissue formation.	6 weeks
Secondary	Inflammatory response using light microscopy	After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria. A. Inflammatory cell response: 0= None or a few scattered inflammatory cells beneath the site of pulp exposure.; Mild inflammatory cells (either acute or chronic).; Moderate inflammatory cell infiltration involving the cervical third of radicular pulp.; Severe inflammatory cell infiltration involving the coronal third of radicular pulp.; B. Tissue disorganization: 0= Normal tissue beneath the site of pulp exposure.; Odontoblast-like cells, odontoblasts, and pulp tissue pattern disorganization.; General disorganization of the pulp tissue pattern.; Pulp necrosis.	6 weeks
Secondary	The Enzyme-Linked Immunosorbent Assay (ELISA) analysis.	After extraction, the tooth will be sectioned under copious water cooling and all remaining pulp tissue will be harvested gently from the radicular portion and stored until the time of assaying. For the ELISA assaying, the frozen pulp samples will be thawed for 15 minutes, and crushed with a glass rod in the eppendorf tube to elute the cytokines from the pulp tissue. IL-8 and IL-10 will be measured using ElISA Kits according to the instructions supplied with the kit and the ratio of IL-8/IL-10 will be taken as an indicator of pulpal inflammation. Cytokines' concentration will be calculated according to the weight of the pulp tissue.	6 weeks