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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05029479
Other study ID # Novel YAMAKIN TMR-Aquabond0
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 13, 2021
Est. completion date December 2022

Study information

Verified date July 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this trial is to test the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)


Description:

To evaluate the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs) P: Population: Geriatric patients with non-carious cervical lesions (NCCLs) I: Intervention: Novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) C: Comparator : 3m ESPE Single Bond Universal Adhesive O: Outcome:Clinical Performance using FDI criteria


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Study Design


Intervention

Other:
Bonding in NCCLs
bonding agent which can resist moisture and has shorter decalcifying and curing time

Locations

Country Name City State
Egypt Faculty of Dentistry , Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

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Outcome

Type Measure Description Time frame Safety issue
Primary Number of fractured restorations First, visual inspection to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure there is no rocking /fracture /ditching in the restoration following FDI criteria ( first visually for total loss followed by tactile inspection using FDI probe for any fracture /rocking or loss of retention. 12 months
Primary Number of restorations with retention loss First, visual inspection to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria 12 months
Secondary Number of restoration with change in colour or texture Evaluation will be done visually following FDI criteria to ensure no change in colour or texture of the restoration 12 months
Secondary Number of restoration caused biological harm Evaluation will be done following FDI criteria using FDI probe to ensure there is no change in restoration that caused any harm to the health of biological structure 12 months
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