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

• Sponsor: Aya Gamal ashour (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04572386
• Collaborator: (none)
• Enrollment: 28
• Arms: 2
• Anticipated Duration (Months): 21

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Non Carious Cervical Lesion	Other: light cure 3m single bond universal bond; Other: Self-cure universal bond (Palfique, Tokuyama, Japan)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Light cure universal bond light cured 3m single bond universal	Other: light cure 3m single bond universal bond; light -cure universal bond
Active Comparator: self cure universal bond self-cure universal bond (Palfique, Tokuyama, Japan)	Other: Self-cure universal bond (Palfique, Tokuyama, Japan); Self-cure universal bond with no light cure

Outcome Measures

Primary Outcome Measures

1. Number of fracture restoration [18 month]

   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

2. number of restoration with retention loss [18-month]

   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

Secondary Outcome Measures

1. Number of restoration with change in colour or texture [18 month]

   Evaluation will be done visually following FDI criteria to ensure no change in colour or texture of the restoration

2. Number of restoration caused biological harm [18 month]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aya Gamal ashour

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aya Gamal ashour, principle investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT04572386
• Other Study ID Numbers: gsda.1986.2
• First Posted: Oct 1, 2020
• Last Update Posted: Oct 1, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Aya Gamal ashour, principle investigator, Cairo University: universal bond; NCCls; 3m single bond universal; Palfique, Tokuyama, Japan; self cure; non carious cervical lesions
• Additional relevant MeSH terms: Uterine Cervical Diseases

Study Results

No Results Posted as of Oct 1, 2020