Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars.
Primary Purpose
Reversible Pulpitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MTA
TheraCal PT
Sponsored by
About this trial
This is an interventional treatment trial for Reversible Pulpitis
Eligibility Criteria
Inclusion Criteria:
- Aged 4 to 7 years , in good general health and mentally free.
- The parents provided written informed consent.
- Cariously exposed primary molars with reversible pulpitis.
- Teeth should be vital.
- Restorable teeth.
- Hemostasis achieved after complete pulpotomy
Exclusion Criteria:
- With systemic disease.
- Physical or mental disability.
- Unable to attend follow-up visits.
- Refusal of participation.
- Previously accessed teeth.
- History of spontaneous or prolonged pain.
- Swelling, tenderness to percussion or palpation, or pathological mobility.
- Pre-operative radiographic pathology such as resorption(internal or external),per-radicular or furcation radiolucency.
- Haemorrhage control is unachievable after pulpotomy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mineral trioxide aggregate (MTA)
TheraCal PT
Arm Description
Survival rate of cariously exposed vital primary molars using MTA+ Curamed (UI, Kwiatkowskiego 1, 37-450 Staleya Wola, Polka)
Survival rate of cariously exposed vital primary molars using TheraCal PT (BISCO Dental Products, Schamberg IL, U.S.A.)
Outcomes
Primary Outcome Measures
Survival rate (Absence of spontaneous pain)
Binary outcome measured with direct questioning to the patient
Survival rate (Absence of spontaneous pain)
Binary outcome measured with direct questioning to the patient
Survival rate (Absence of swelling)
Binary outcome measured visually by intraoral/extraoral examination
Survival rate (Absence of swelling)
Binary outcome measured visually by intraoral/extraoral examination
Secondary Outcome Measures
Absence of periapical radiolucency or absence of internal/external root resorption
Binary outcome detected with periapical x-ray by parallel technique using XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland).
Time lapse till final restoration performed.
Continuous outcome measured with a Stopwatch in minutes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04617600
Brief Title
Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars.
Official Title
Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars: A Randomized Controlled Pilot Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to assess the effect of TheraCal PT pulpotomy versus MTA pulpotomy on the survival rate of cariously exposed vital primary molars.
Detailed Description
for both interventions ,
Informed consent from participating parents.
Baseline records photographs, percussion test, periapical radiograph and personal data collection.
Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the type of dressing material that will be used then writing patient name and I.D. on it and will be opened after performing the access cavity).
Diagnostic chart with personal, medical and dental history will be filled.
Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnosis is established after clinical examination).
Preoperative and Postoperative photographs will be taken.
The radiographic examination will be performed by taking periapical x-ray using (parallel technique) through machine to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using x-ray holding device.
Preoperative and postoperative radiograph will be taken by parallel technique using extension cone paralleling (XCP) film holder.
Administration of inferior alveolar nerve block (Septodont, Scandonest® 2% L Mepivacaine hydrochloride (HCl). 2% and Levonordefrin 1:20,000 Injection, U.S.P.) at the side of the affected tooth.
Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level. Hemostasis will be achieved by the application of a wet cotton pellet.
Children will then be allocated into either one of the groups alternatively depending on the pulpotomy medicament used as follows:
Group I (Experimental group) TheraCal PT pulpotomy.
Group II (Control group) MTA pulpotomy.
Group I (Experimental group) TheraCal PT:
After complete hemostasis, TheraCal PT (BISCO Dental Products, Schamberg illinois (IL), U.S.A.) will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2mm then the rest of the pulp chamber will be filled with glass ionomer cement.
Tooth will then be restored with stainless steel crown.
Group II (Control group) MTA pulpotomy:
After complete hemostasis, MTA+ Curamed (ul. Kwiatkowskiego 1, 37-450 stylosa Wola, Polka) will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be 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, followed by application of glass ionomer cement.
Tooth will then be restored with stainless steel crown.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reversible Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mineral trioxide aggregate (MTA)
Arm Type
Active Comparator
Arm Description
Survival rate of cariously exposed vital primary molars using MTA+ Curamed (UI, Kwiatkowskiego 1, 37-450 Staleya Wola, Polka)
Arm Title
TheraCal PT
Arm Type
Experimental
Arm Description
Survival rate of cariously exposed vital primary molars using TheraCal PT (BISCO Dental Products, Schamberg IL, U.S.A.)
Intervention Type
Drug
Intervention Name(s)
MTA
Other Intervention Name(s)
Mineral trioxide aggregate
Intervention Description
Survival rate using MTA in cariously exposed vital primary molars
Intervention Type
Drug
Intervention Name(s)
TheraCal PT
Other Intervention Name(s)
TheraCal PT®
Intervention Description
Survival rate using TheraCal PT in cariously exposed vital primary molars
Primary Outcome Measure Information:
Title
Survival rate (Absence of spontaneous pain)
Description
Binary outcome measured with direct questioning to the patient
Time Frame
"3 months"
Title
Survival rate (Absence of spontaneous pain)
Description
Binary outcome measured with direct questioning to the patient
Time Frame
"6 months"
Title
Survival rate (Absence of swelling)
Description
Binary outcome measured visually by intraoral/extraoral examination
Time Frame
"3 months"
Title
Survival rate (Absence of swelling)
Description
Binary outcome measured visually by intraoral/extraoral examination
Time Frame
"6 months"
Secondary Outcome Measure Information:
Title
Absence of periapical radiolucency or absence of internal/external root resorption
Description
Binary outcome detected with periapical x-ray by parallel technique using XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland).
Time Frame
"6 months"
Title
Time lapse till final restoration performed.
Description
Continuous outcome measured with a Stopwatch in minutes.
Time Frame
"During procedure".
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 4 to 7 years , in good general health and mentally free.
The parents provided written informed consent.
Cariously exposed primary molars with reversible pulpitis.
Teeth should be vital.
Restorable teeth.
Hemostasis achieved after complete pulpotomy
Exclusion Criteria:
With systemic disease.
Physical or mental disability.
Unable to attend follow-up visits.
Refusal of participation.
Previously accessed teeth.
History of spontaneous or prolonged pain.
Swelling, tenderness to percussion or palpation, or pathological mobility.
Pre-operative radiographic pathology such as resorption(internal or external),per-radicular or furcation radiolucency.
Haemorrhage control is unachievable after pulpotomy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reem Mohamed Gaber, B.Sc
Phone
01115578688
Ext
0020
Email
reem.gaber@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Passant Nagi, PHD
Phone
01280557107
Ext
0020
Email
Passant.Nagi@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
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Survival Rate After TheraCal PT Pulpotomy Versus MTA Pulpotomy in Children With Vital Primary Molars.
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