Back to resultsClinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA
Primary Purpose
Pulp Disease, Dental
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
MTA material
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Disease, Dental
Eligibility Criteria
Inclusion Criteria:
- - Medically free children who will be able and cooperative in all steps of the study.
- - Asymptomatic primary molars with a deep carious lesion.
- - Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.
3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.
4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.
Exclusion Criteria:
1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.
6 - Parent or guardians who refuse participating in the study
Sites / Locations
- Faculty of dentistry cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group A
group B
Arm Description
placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 9.The pellet will be remove, and the pulp chamber filled with MTA. 10.The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement
Pre-operative radiograph showing all roots and their apices. Local anesthesia will be administered and a rubber dam will take place ,that ensure good isolation of the treated teeth. Removal of caries Pulp chambers will access using a no.330 bur in a high-speed hand piece with water coolant. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece Pulp amputation will perform using a spoon excavator. Hemorrhage control will obtain within 5 minutes using sterile cotton pellets placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) The pellet will be remove, and the pulp chamber will be filled with MTA. The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement. The periapical radiographic will be taken at this baseline visit .
Outcomes
Primary Outcome Measures
postoperative pain
analog scale
postoperative pain
analog scale
postoperative pain
analog scale
postoperative pain
analog scale
swelling
clinical examination
swelling
clinical examination
swelling
clinical examination
swelling
clinical examination
mobility
clinical examination
mobility
clinical examination
mobility
clinical examination
mobility
clinical examination
Secondary Outcome Measures
root resorption
periapical radiograph
root resorption
periapical radiograph
root resorption
periapical radiograph
root resorption
periapical radiograph
Bone resorption
periapical radiograph
Bone resorption
periapical radiograph
Bone resorption
periapical radiograph
Bone resorption
periapical radiograph
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04650113
Brief Title
Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA
Official Title
Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA : A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 3, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
that's comparison between partial and complete pulpotomy techniques in primary teeth
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Disease, Dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All participants will be randomly assigned to know which one of the right or left side will be allocated randomly in either the control or the intervention group.
Sequence Generation Eligible consented participants will be randomly assigned to know which one of the participants will be control or intervention group according to a sequence generated on a Microsoft Excel sheet where the intervention (I) and the control (C) are simply randomized. The table of sequence generation will be kept with the co-supervisor.
Allocation
Randomized
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 9.The pellet will be remove, and the pulp chamber filled with MTA. 10.The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Pre-operative radiograph showing all roots and their apices.
Local anesthesia will be administered and a rubber dam will take place ,that ensure good isolation of the treated teeth.
Removal of caries
Pulp chambers will access using a no.330 bur in a high-speed hand piece with water coolant.
Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece
Pulp amputation will perform using a spoon excavator.
Hemorrhage control will obtain within 5 minutes using sterile cotton pellets placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude )
The pellet will be remove, and the pulp chamber will be filled with MTA.
The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement.
The periapical radiographic will be taken at this baseline visit .
Intervention Type
Combination Product
Intervention Name(s)
MTA material
Other Intervention Name(s)
partial pulpotomy procedure
Intervention Description
Partial pulpotomy is a procedure in which the inflamed tissue beneath an exposure is removed to a depth of 1 to 3 mm or deeper to reach healthy pulp tissue.
Primary Outcome Measure Information:
Title
postoperative pain
Description
analog scale
Time Frame
1 week
Title
postoperative pain
Description
analog scale
Time Frame
1 month
Title
postoperative pain
Description
analog scale
Time Frame
3 months
Title
postoperative pain
Description
analog scale
Time Frame
6 months
Title
swelling
Description
clinical examination
Time Frame
1 week
Title
swelling
Description
clinical examination
Time Frame
1 month
Title
swelling
Description
clinical examination
Time Frame
3 months
Title
swelling
Description
clinical examination
Time Frame
6 months
Title
mobility
Description
clinical examination
Time Frame
1 week
Title
mobility
Description
clinical examination
Time Frame
1 month
Title
mobility
Description
clinical examination
Time Frame
3 months
Title
mobility
Description
clinical examination
Time Frame
6 months
Secondary Outcome Measure Information:
Title
root resorption
Description
periapical radiograph
Time Frame
1 week
Title
root resorption
Description
periapical radiograph
Time Frame
1 month
Title
root resorption
Description
periapical radiograph
Time Frame
3 months
Title
root resorption
Description
periapical radiograph
Time Frame
6 months
Title
Bone resorption
Description
periapical radiograph
Time Frame
1 week
Title
Bone resorption
Description
periapical radiograph
Time Frame
1 month
Title
Bone resorption
Description
periapical radiograph
Time Frame
3 months
Title
Bone resorption
Description
periapical radiograph
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Medically free children who will be able and cooperative in all steps of the study.
- Asymptomatic primary molars with a deep carious lesion.
- Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.
3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.
4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.
Exclusion Criteria:
1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.
6 - Parent or guardians who refuse participating in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fatma abdelraouf, Msc
Phone
00201060771955
Email
fatmaraouf.fr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
adel El-bardissy, prof
Organizational Affiliation
Associate Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
rasha ragab, phd
Organizational Affiliation
Lecturer of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of dentistry cairo university
City
Al Manyal
State/Province
Cairo
ZIP/Postal Code
11562
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
fatma abdelraouf, Bsc
Phone
00201060771955
Email
fatmaraouf.fr@gmail.com
First Name & Middle Initial & Last Name & Degree
Rasha Ragab
Phone
00 20 100 7505888
Email
Rashaadelragab@gmail.com
First Name & Middle Initial & Last Name & Degree
Fatma Abdelraouf, Bsc
First Name & Middle Initial & Last Name & Degree
Rasha Ragab, PhD
First Name & Middle Initial & Last Name & Degree
Adel Albardissy, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA
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