Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth
Primary Purpose
Regenerative Endodontic Procedures, Necrotic Pulp
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Regenerative endodontic procedues
Sponsored by
About this trial
This is an interventional treatment trial for Regenerative Endodontic Procedures focused on measuring Platelet rich fibrin, Treated dentine matrix
Eligibility Criteria
Inclusion Criteria: Patients aged from 6-11 years presenting with a non-vital permanent immature tooth. Exclusion Criteria: History of uncontrolled diabetes Immunosuppression Chronic systemic disease if a treatment is required Periodontal disease
Sites / Locations
- Faculty of Dentistry, Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treated Dentine Matrix (TDM)
Platelet Rich Fibrin (PRF)
Arm Description
Participants treated with TDM paste
Participants treated with PRF
Outcomes
Primary Outcome Measures
Clinical evaluation
Clinically evaluating the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.
Secondary Outcome Measures
Radiographic evaluation
Radiographically evaluating the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05775081
Brief Title
Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth
Official Title
Efficacy of Human Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will be conducted to clinically evaluate the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.
Detailed Description
A) Patient grouping:
Patients will be randomly allocated into 2 groups using sealed envelope method of randomization
Group (A):
Teeth to be treated by h-TDM paste (n=10).
Group (B):
Teeth to be treated by platelet rich fibrin (PRF) regeneration (n=10).
B) Procedures:
Diagnosis of pulp necrosis, clinical and radiographic examination. 11 For each patient, the protocol of treatment is composed of 7 sessions. The follow-up takes place over a 15 months' period. Day 0 is considered as the day of the first treatment session.
I- Day 0:
Pre-operative Cone Beam Computed Tomography (CBCT) is taken at this visit.
Calcium hydroxide canal conditioning for 2 weeks regardless of the treatment group. This is done in the following sequence:
Administration of local anesthesia, then rubber dam isolation.
Preparing an access cavity and establishing the working length by taking a radiograph with a file inserted into the root canal within 2 mm of the radiographic apex.
The canal is cleaned by irrigation with 1.25% sodium hypochlorite and the use of manual files. The cleaning and shaping are realized with files with a very light parietal action to avoid the canal widening and the weakening of the root walls. Above all, it consists in removing the pulp remnants.
Then, the canal is dried with paper point and can be filled with calcium hydroxide. Calcium hydroxide paste is prepared by mixing the calcium hydroxide powder and Barium Sulfate as a radio-opacifier mixed with sterile distilled water. A plug of calcium hydroxide is placed in the canal and condensed to the apical end of the root with a plugger. Other layers of calcium hydroxide are placed till complete canal filling.
The intracanal dressing quality is checked with a radiograph. The access cavity is temporarily sealed with a resin modified glass ionomer cement. This calcium hydroxide canal conditioning is performed for all patients to allow the complete disinfection.
II- Day 0+15:
This session starts with administration of local anesthesia, placement of a rubber dam and the removal of all the calcium hydroxide by copious saline irrigation. Then, treatment according to the assigned group:
Group A (h-TDM paste):
Preparation of h-TDM:
Mentioned before.
Preparation of h-TDM paste:
Mentioned before. 3- Operative procedures:
The h-TDM paste will be placed into the canal by sterile amalgam carrier and condensed to the apical end of the root with a plugger to create a 4 mm apical plug. Radiograph will be taken to verify proper placement of the mixture. Then, 1mm of MTA will be placed over this paste.
Then, the access cavity will be filled with resin modified glass ionomer.
Group B (PRF regeneration):
13
Ten ml of venous blood will be withdrawn from the child's forearm to a sterile test tube without anticoagulant and will be centrifuged in 3000 rpm for 10 minutes to prepare PRF, which appears as a membrane between the free plasma in the top and RBCs in the bottom of the tube.
Platelet rich fibrin will be withdrawn from the test tube using sterile tweezer and put into sterile gauze and cut into small pieces using sterile scissor.
Root canal will be copiously irrigated by sterile saline and dried with sterile paper points. Platelet rich fibrin small pieces will be condensed into the root canal till the apex using sterile plugger. Then, 2mm of MTA will be placed over the PRF till CEJ. Then, access cavity will be sealed by glass ionomer.
III- 3 months:
Clinical and radiographic control for all patients.
IV- 6 months:
Clinical and radiographic control for all patients.
V- 9 months:
Clinical and radiographic control for all patients.
VI- 12 months:
• Clinical and radiographic control for all patients.
VII- 15 months:
Clinical and radiographic control for all patients.
CBCT is taken at this visit. The x-rays of each patient are taken with the aid of film holder to be standardized and reproducible, so that they can be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regenerative Endodontic Procedures, Necrotic Pulp
Keywords
Platelet rich fibrin, Treated dentine matrix
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treated Dentine Matrix (TDM)
Arm Type
Experimental
Arm Description
Participants treated with TDM paste
Arm Title
Platelet Rich Fibrin (PRF)
Arm Type
Experimental
Arm Description
Participants treated with PRF
Intervention Type
Other
Intervention Name(s)
Regenerative endodontic procedues
Intervention Description
Treating non-vital immature permanent teeth with either treated dentine matrix paste or platelet rich fibrin
Primary Outcome Measure Information:
Title
Clinical evaluation
Description
Clinically evaluating the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Radiographic evaluation
Description
Radiographically evaluating the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged from 6-11 years presenting with a non-vital permanent immature tooth.
Exclusion Criteria:
History of uncontrolled diabetes
Immunosuppression
Chronic systemic disease if a treatment is required
Periodontal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Asal, MDS
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ibrahim H Elkalla, PhD
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yousry M Elhawary, PhD
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ashraf Y Alhsoainy, PhD
Organizational Affiliation
Mansoura University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth
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