Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05006755 |
| Other study ID # |
1692 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 10, 2021 |
| Est. completion date |
September 10, 2022 |
Study information
| Verified date |
August 2021 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
- Preservation of the primary teeth is a mandatory issue for maintaining the integrity of
the normal dentition and functioning till the eruption of the successors.
- furcal perforations may occur due to iatrogenic and non-iatrogenic causes.
- Despite the high successful outcomes in perforation repair with MTA, there are some
issues which prevent the clinicians from using it for many cases such as its very long
setting time and its difficult manipulation.
- Biodentin could be used as an alternative to MTA in reparative treatment procedures due
to its ability to provide a hermetic seal and durable restoration and thus an optimal
sealing is expected.
- The importance of the trial lies in testing the sealing ability of Biodentine using
scanning electron microscope. Biodentine has short setting time and is easier in
manipulation than MTA which are major needs when dealing with pediatric patients to be
able to give best results in short time.
Description:
- By immediate diagnosis and sealing of furcal perforations in primary molar teeth with a
biocompatible material, the prognosis is usually favorable.
- MTA has high clinical efficacy, but there were some drawbacks which made it difficult
for the clinicians to use it in many cases. The major ones being very long setting time
and difficult manipulation.
- Biodentine has a good sealing ability, high compressive strengths, short setting time,
biocompatibility, bioactivity and biomineralization properties that make it available to
be used in endodontic repair procedures.
- 42 extracted primary molar teeth will be collected, sterilized and stored according to
the Occupational Safety and Health Administration guidelines and regulations.
- A standard access cavity will be prepared in each tooth using a diamond bur and non-end
cutting bur in high-speed handpiece with water spray. A 0.5 mm round bur will be used to
standardize the size of furcal perforation, and the furcal involvement will be made on
the center of the pulpal floor.
- After the furcal perforation, the blocks will randomly be divided into two groups
- Control group: MTA Group, Using amalgam applicator the material will be carried and
sealed in the furcation site.
- Intervention group: Biodentin Group,The material will be scooped and applied on the
perforation site.
- Outcome : sealing ability measurement method : scanning electron microscope unit of
measurement : µm
