Clinical Performance of Low Technique Sensitive Self Cured Universal Adhesive Vrs Light Cured Universal Adhesive in Patients With (NCCLs): 18 m RCT

Non Carious Cervical Lesion Clinical Trial

Official title:

Clinical Performance of Low Technique Sensitive Self-cured Universal Adhesive Versus Light Cured Universal Adhesive in Patients With Non-carious Cervical Lesions (NCCLs): 18 Month Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04572386
• Other study ID #: gsda.1986.2
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: July 2022

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: Aya Gamal, masters
• Phone: 01004222615
• Email: yoyo_ga[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to evaluate the clinical performance of self-cured adhesive versus light cured universal adhesive in non-carious cervical lesions (NCCL) resin composite restorations after 18 month

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: July 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• particepant with age rang 18-55

• particepant with non carious cervical lesion

Exclusion Criteria:

• particepant outside age rang

• particepant with periodontal problem that might affect the teeth to be treated

Related Conditions & MeSH terms

• Non Carious Cervical Lesion
• Uterine Cervical Diseases

Intervention

Other:
• light cure 3m single bond universal bond
light -cure universal bond
• Self-cure universal bond (Palfique, Tokuyama, Japan)
Self-cure universal bond with no light cure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aya Gamal ashour

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of fracture restoration	Frist visual evaluation 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 ( first visually for total loss .followed by tactile inspection using fdi prob for any fracture /rocking or loss of retention	18 month
Primary	number of restoration with retention loss	Frist visual evaluation 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	18-month
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	18 month
Secondary	Number of restoration caused biological harm	Evaluation will be done following FDI criteria using FDI prob to ensure no change in restoration that caused any harm to the health of biological strucure	18 month