Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04331964
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2020-03-29
Brief Title:
The Use of Platelet-Rich Fibrin in Partial Pulpotomy Procedure
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Dental Pulp Response to The Combination Use of Platelet-Rich Fibrin and Mineral Trioxide Aggregate in Partial Pulpotomy of Sound Human Premolars A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the clinical and histological pulp responses when MTA and a combined of MTAPRF is used as pulp-capping agents after partial pulpotomy
Detailed Description:
Partial pulpotomy is generally considered as the treatment of choice for immature permanent teeth with reversible injury Mineral trioxide aggregate MTA is a gold standard material as pulp capping agent in term of vital pulp therapy Despite many advantages MTA has a long setting time little biological inductivity difficult handling characteristics and high cost
An essential aspect of tooth tissue engineering is the identification of a suitable scaffold to support cell growth and tissue regeneration Platelet-Rich Fibrin PRF is a second generation platelet concentrate It is strictly autologous and helps to release the growth factors necessary for the regeneration of dentin pulp complex Therefore PRF seems to be a suitable scaffold in vital pulp therapy
Study sample 24 intact maxillary or mandibular premolars which will be extracted for orthodontic reasons in 12 healthy volunteers The sample will be chosen from the patients who are coming to the Orthodontic department in the Faculty of dentistry - Damascus university
This study will be performed as split mouth study For each selected patient one premolar will be randomly allocated to MTA only and the other to combined MTAPRF by a toss of coin The main operator will give each patient a numerical code from 1 to 12 whilst the teeth will have an alphabetical coding eg For the patient coded as 1 premolar with MTA will be coded as 1-a the other premolar with MTAPRF will be coded as 1-b In all patient documents the teeth will be labeled in the same way so that the clinical examiner and a pathologist will be blinded to the capping technique used for each tooth whilst the main operator who perform a pulpotomy will know which technique is used for each premolar
Postoperative pain and sensitivity to thermal stimuli will be analyzed after the treatment between two sides
After 8 weeks the teeth will be extracted and histologically evaluated in terms of inflammation dentin bridge formation and its appearance
An essential aspect of tooth tissue engineering is the identification of a suitable scaffold to support cell growth and tissue regeneration Platelet-Rich Fibrin PRF is a second generation platelet concentrate It is strictly autologous and helps to release the growth factors necessary for the regeneration of dentin pulp complex Therefore PRF seems to be a suitable scaffold in vital pulp therapy
Study sample 24 intact maxillary or mandibular premolars which will be extracted for orthodontic reasons in 12 healthy volunteers The sample will be chosen from the patients who are coming to the Orthodontic department in the Faculty of dentistry - Damascus university
This study will be performed as split mouth study For each selected patient one premolar will be randomly allocated to MTA only and the other to combined MTAPRF by a toss of coin The main operator will give each patient a numerical code from 1 to 12 whilst the teeth will have an alphabetical coding eg For the patient coded as 1 premolar with MTA will be coded as 1-a the other premolar with MTAPRF will be coded as 1-b In all patient documents the teeth will be labeled in the same way so that the clinical examiner and a pathologist will be blinded to the capping technique used for each tooth whilst the main operator who perform a pulpotomy will know which technique is used for each premolar
Postoperative pain and sensitivity to thermal stimuli will be analyzed after the treatment between two sides
After 8 weeks the teeth will be extracted and histologically evaluated in terms of inflammation dentin bridge formation and its appearance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None