Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT04617600 |
Other study ID # |
14422019496708 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2022 |
Est. completion date |
November 1, 2022 |
Study information
Verified date |
March 2022 |
Source |
Cairo University |
Contact |
Reem Mohamed Gaber, B.Sc |
Phone |
01115578688 |
Email |
reem.gaber[@]dentistry.cu.edu.eg |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
for both interventions ,
1. Informed consent from participating parents.
2. Baseline records photographs, percussion test, periapical radiograph and personal data
collection.
3. 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).
4. Diagnostic chart with personal, medical and dental history will be filled.
5. Clinical examination will be performed to assess the clinical inclusion criteria.
(Pulpal and periapical diagnosis is established after clinical examination).
6. Preoperative and Postoperative photographs will be taken.
7. 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.
8. Preoperative and postoperative radiograph will be taken by parallel technique using
extension cone paralleling (XCP) film holder.
9. 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.
10. 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:
1. 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.
2. Tooth will then be restored with stainless steel crown.
Group II (Control group) MTA pulpotomy:
1. 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.
2. Tooth will then be restored with stainless steel crown.