Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775081
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-03-07
Brief Title:
Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Efficacy of Human Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth
Status:
COMPLETED
Status Verified Date:
2023-09
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:
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 n10
Group B
Teeth to be treated by platelet rich fibrin PRF regeneration n10
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 125 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 015
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
1 Preparation of h-TDM
Mentioned before
2 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 childs 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
Patients will be randomly allocated into 2 groups using sealed envelope method of randomization
Group A
Teeth to be treated by h-TDM paste n10
Group B
Teeth to be treated by platelet rich fibrin PRF regeneration n10
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 125 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 015
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
1 Preparation of h-TDM
Mentioned before
2 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 childs 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
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?:
False
Is an FDA AA801 Violation?:
None