Evaluation of Adhering Flowable Composite With and Without Adhesive Vs Flowable in Cervical Lesions

Dental Restoration Failure Clinical Trial

Official title:

Clinical Evaluation of a Moist Bonding Self-Adhering Flowable Composite With and Without Adhesive System Versus Conventional Flowable Composite in Cervical Caries Lesions: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03859284
• Other study ID #: Mon15
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: mona mounir, msc
• Phone: 01001171585
• Email: monamounir1987[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.

Description:

flowable composite is considered a gold standard in class V restorations due to its resilient character the prevents its dislodgement in this area. self-adhering flowable composite would simplify the clinical steps and claims to improve the adhesion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 1, 2022
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

Inclusion Criteria:

• patients with anterior cervical carious lesions.
• Pulp asymptomatic vital carious anterior teeth.
• Co-operative patients approving to participate in the trial.

Exclusion Criteria:

• Pregnancy.
• Disabilities.
• Systemic disease or severe medical complications.
• Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection.
• Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
• Heavy smokers.

Related Conditions & MeSH terms

• Dental Restoration Failure

Intervention

Other:
• flowable resin composite
gold standard
• self adhering flowable
moist bonding self adhering flowable composite
• self adhering flowable with adhesive
moist bonding self adhering flowable composite with the aid of an adhesive system.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes	Biological properties (Postoperative hypersensitivity & tooth vitality, Recurrence of caries, erosion & abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral & general health).; Esthetic properties (Surface luster, Staining (surface &margin),Color match & translucency & Esthetic anatomical form).; Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour &wear (quantitatively & qualitatively), Proximal anatomical form(contact point &contour), Radiographic examination(when applicable) &Patient's view; For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory & poor).; Subscales will not be combined	Change from the baseline at 6 months and12 months]