An Early Phase 1 interventional study of sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India and Biodentine (Septodont, Saint-Maur-des-Fossés, France) in Carious Exposure of Pulp, sponsored by Cairo University. Status unknown. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-30.
Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment
Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration of the remaining pulp tissue using mineral trioxide aggregate and recently Biodentine have been utilized.
The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promoting the healing of the root pulp and be compatible with the physiological process of root resorption.
Searching for more pulpotomy agents, Collagen, a protein that's present abundantly in humans, is an important component of connective tissues and performs multiple functions including wound healing.
Enamel and dentin contain Collagen as one of the components in their organic ground matrix.
Collagen has been used widely in dentistry in periodontal and implant therapy as scaffold for preventing the migration of epithelial cells and encouraging wound repopulation by cells with high regenerative potential.
The Collagen available for dental implication is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contamination. The collagen particles
Pulpotomy is considered the gold standard procedure for treating cariously exposed pulps in asymptomatic primary teeth. Which is based on the healing ability of the radicular pulp tissue following amputation of the infected coronal pulp.
Mineral trioxide aggregate (MTA) has been recommended as the gold standard for vital pulp therapy; however, it has some disadvantages, such as long setting time, poor handling properties, high cost, and the potential for tooth discoloration. Biodentine (Septodont, Saint-Maur-des-Fossés, France), one of the new-generation, bioactive endodontic cements, has been claimed to have improved properties over MTA.
Biodentine presents high biocompatibility with the dental pulp, it has high antibacterial effects and antifungal activity, has a shorter setting time than MTA as a result of the calcium chloride in the liquid component of Biodentine. It also has higher flexural strength, compressive strength and modulus of elasticity than MTA.
Consequently, Biodentine can be used as a pulp dressing as well as a base material.
Quest is on for newer pulpal medicaments that are biocompatible and capable of healing the dental pulp by producing reparative dentin and/or dentinal bridge in response to various stimuli and surgical exposure.
Collagen has a proven rate of success in the field of dentistry as guided tissue regeneration, root conditioning, hemostatic, and wound dressing agent. It has inherent properties like low immune response and toxicity, ability to promote cellular growth and attachment, homeostasis, and added advantage of antibiotic incorporation.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children:
<!-- -->
Exclusion Criteria:
Children:
<!-- -->
(sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India)
Drug: sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India
Biodentine (Septodont, Saint-Maur-des-Fossés, France)
Drug: Biodentine (Septodont, Saint-Maur-des-Fossés, France)
Collagen based pulpotomy will be applied (sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India)according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm
Biodentine (Septodont, Saint-Maur-des-Fossés, France) will be applied according to the manufacturer's instructions and placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet.
absence of internal root resorption
radiographic measurement of internal root resorption
Time frame: 12 months
absence of pain and swelling
number of participants with pain and swelling
Time frame: 12 months
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cairo University