NCT03786302

Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Nourhan M.Aly · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulpotomy

Interventions

Type	Name	Description
DRUG	TAMP bioglass	TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
DRUG	Biodentine	TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth

Timeline

• Start date: 2016-12-06
• Primary completion: 2018-08-15
• Completion: 2018-10-20
• First posted: 2018-12-26
• Last updated: 2020-10-14

Locations

1 site across 1 country: Egypt