Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04561934 |
| Other study ID # |
2629 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
November 1, 2021 |
Study information
| Verified date |
December 2020 |
| Source |
Cairo University |
| Contact |
laila Akmal elokaly, master |
| Phone |
01147277266 |
| Email |
lailaelokaly15[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to evaluate the effect of SDF in maintaining pulp health after
partial caries removal in permanent teeth with deep occlusal carious lesion clinically and
radiographically
Description:
Pre-operative clinical assessment:
Before starting the study, the participants will undergo radiographic examination to ensure
that the carious lesion penetrate at least the inner one-half of the dentin thickness and
show normal lamina dura and periodontal ligament.
Cavity preparation procedure:
Under local anesthesia and rubber dam isolation. A high-speed handpiece (T3 mini, Sirona
GmbH, Bensheim, Germany) under air/water coolant and No. #245 bur will use to obtain the
cavity outline allowing access to the carious lesion beyond the dentin-enamel junction.
(Bitello-Firmino et al., 2018). Then, complete caries excavation will be performed in the
cavity except at the floor where partial caries removal will be performed using sharp sterile
excavator. Then cavities will be randomly divided into two groups according to the selected
sealed envelopes.
Restorative treatment:
- For the control group Isolation of the prepared cavity will be maintained using rubber
dam. The cavity will be lined with a liquid-paste, resin-modified GIC liner (Fuji Lining
LC Paste Pak; GC, Tokyo, Japan) in 0.5-1 mm thickness over the entire dentin floor, and
then bonded with self-etching adhesive (Clearfil SE Bond; Kuraray Medical, Okayama,
Japan).The bonded cavity will be filled incrementally with resin composite restoration
(Filtek Z350 XT,3MESPE) and then will be light cured for 20s.
- For the intervention group Isolation of the prepared cavity will be maintained using
rubber dam. Riva star SDF will be applied over the entire dentin floor in two steps: The
first Step, the silver capsule solution will be applied using the silver brush provided.
Then the second Step, the green capsule solution will be applied in a generous amount
immediately after applying the silver capsule solution at the same treated site until
the treated surface color change from creamy white to clear. And then, after one-minute
Riva star SDF will be blot dried or if the clinical situation permits, will be wash
thoroughly with water for at least 10 seconds and then air dry without desiccation.
Resin modified glass-ionomer liner will be then applied over Riva star SDF prior to
resin composite restoration application.
12. Outcomes: The primary outcome of this clinical trial is success, express as a binary
variable indicating whether the restored tooth maintained its pulp vitality after 12
months (T2). Success will evaluate by a positive response to cold pulp testing, absence
of spontaneous pain, no tenderness to percussion, absence of periapical radiolucency .
