Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05617703 |
| Other study ID # |
14422018462089 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2022 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
November 2022 |
| Source |
Cairo University |
| Contact |
zayed |
| Phone |
00201012561397 |
| Email |
aya_magdy[@]dentistry.cu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this [type of study: Randomized clinical trial] to compare the clinical
performance of using glass ionomer with advanced glass hybrid technology (AGH) in cervical
carious lesion, versus Resin modified glass ionomer (RMGI) using esthetic and mechanical
properties according to FDI criteria over one year.
in adult patients with cervical carious lesion.
The main question it aims to answer are:
• Will the use of glass ionomer with advanced glass hybrid technology, achieved through
introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid
powders within conventional glass ,or Resin Modified Glass Ionomer have better mechanical and
estheic properties over one year in adult patients with cervical carious lesions ?
Participants will be assessed for medical and dental histories first. Then an examination of
the patients will be done using visual inspection by using a dental mirror and probe.
Eligible patients according to inclusion and exclusion criteria will be informed about all
procedures with follow up time if they accept, their signature on written informed consents
will be obtained. Eligible participants will be randomly divided into two groups according to
the type of restoration that will be received after class V cavity preparations for carious
cervical lesions.
Patients will be given local anaesthesia (Mepecaine - L Cartridges) as required, and the
teeth will be isolated. A No. #330 bur (MANI, INC, Japan) in a high-speed hand piece with
air/water coolant will be used to prepare class V cavity. Sharp excavators of suitable size
were used to excavate soft carious lesions in dentin. the prepared cavity will be isolated
with rubber dam.
The first group (A) will be received resin modified glass ionomer restorative material and
the second group (B) will be received advanced glass hybrid glass ionomer . Each restoration
will be evaluated for clinical parameters after finishing and polishing at baseline and
regular recalls of 6 months and one year. The restorations will be clinically examined
according to FDI criteria criteria in terms of esthetic and mechanical properties . The
information that will be obtained will be collected and statistically analyzed.
Description:
Eligibility criteria
The participants were chosen according to the following eligibility criteria:
Inclusion criteria Exclusion criteria
Patient inclusion:
1. Patients aging ≥18 years.
2. Patients with High caries risk.
3. Patients with untreated cervical caries lesion that need restorative treatment.
4. Males or females
5. No abnormal occlusion for selected teeth.
6. Patients with good likelihood of recall availability
Tooth inclusion:
1. Permanent teeth.
2. Absence of mobility.
3. Primary carious lesions.
4. Vital with positive reaction to thermal stimulus .
Patient exclusion:
1. Participants with general/systemic illness.
2. Concomitant participation in another research study.
3. Inability to comply with study procedures.
4. Heavy bruxism habits.
5. Last experience with allergic reactions against any components of the used materials.
6. Patients receiving orthodontic treatment.
7. Teeth supporting removable prosthesis
8. Patients with cervical caries lesions that need crown restoration.
9. Xerostomia.
Tooth exclusion:
1. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to
pressure.
2. Non-vital teeth.
3. Periapical Abscess or Fistula.
- Outcomes:
For each recall examination, two independent evaluators will perform the direct clinical
evaluation at baseline, after 6 and 12 months using written criteria based on FDI criteria.
