Effect of Caffeic Acid Phenethyl Ester as a Matrix Metalloproteinase Inhibitor: Randomized Controlled Clinical Trial

NCT02744703 | Completed DMC

• 1 other identifier: 04.10.2012; no:12-8/6
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Matrix metalloproteinases (MMPs); activated by the application of adhesive systems on dentin cause degradation of the collagen proteins and loss of bond strength in adhesive restorations. Caffeic acid phenethyl ester (CAPE) showed inhibitory activities on dentinal MMPs. It is hypothesised that dentin pretreatment with CAPE, as an MMP inhibitor, would be beneficial for the bonding of resin material and tooth substrate over the course of time. This study evaluated the effect of 5 % CAPE pretreatment on the microtensile bond strength of a nanohybrid resin restoration applied with total-etch or self-etch adhesive systems on 10 patients (12-18 yrs). Two standard cavities (3 x 3 x 4 mm) prepared on the occlusal surfaces of one of the two premolar teeth in each patient were randomly assigned into four treatment groups (n=10); 5% CAPE pretreatment and total-etch adhesive (TC), Total-etch adhesive (control) (T), 5% CAPE pretreatment and self-etch adhesive (SC), Self-etch adhesive (control) (S) followed by restoration and 3 months of intra-oral functioning. After teeth extraction, the specimens were stored in distilled water+thymol solution at 4°C to inhibit microbial growth and used in one week period. Dentin-composite sticks were obtained from each restoration for µTBS tests and scanning electron microscopy (SEM) evaluation. Failure mode analysis was performed microscopically. Data were analysed statistically using Repeated Measure ANOVA (p \< 0.05). Dentin pretreatment with CAPE solution (5%) for 60 seconds significantly increased the composite resin restorations' bond strengths to dentin applied with either total-etch or self-etch adhesive system. Thus it can be used as an MMP inhibitor prior to the the resin restorations. However further long term clinical studies are needed to support the use of CAPE pretreatment along with self-etch and total-etch adhesive systems.

Conditions

Matrix Metalloproteinase Inhibitors; Composite Resins

Outcome Measures

Primary Outcomes (1)

• Determination of structural integrity of hybrid layer in forty restorations on 10 patients using scanning electron microscopy after application of different adhesive strategies and a matrix metalloproteinase inhibitor.

  2 years

Study Arms (4)

self-etch adhesive

ACTIVE COMPARATOR

application of self-etch adhesive on cavities.

Drug: self-etch adhesive

CAPE-S

EXPERIMENTAL

CAPE before self-etch adhesive

Drug: CAPE-S

total-etch adhesive

ACTIVE COMPARATOR

total-etch adhesive on cavities.

Drug: total-etch adhesive

CAPE-T

EXPERIMENTAL

CAPE before total-etch adhesive application

Drug: CAPE-T

Interventions

total-etch adhesive DRUG

comparator use of total-etch adhesive

Also known as: adhesive

total-etch adhesive

CAPE-T DRUG

experimental group

Also known as: CAPE solution

CAPE-T

self-etch adhesive DRUG

comparator use of total-etch adhesive

Also known as: adhesive

self-etch adhesive

CAPE-S DRUG

experimental group

Also known as: CAPE solution

CAPE-S

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Occlusally functioning teeth without any anomalies
• Good oral hygiene
• No systemical disorders
• No periodontal diseases
• No allergic reactions to the dental materials

You may not qualify if:

• Patients not eligible for premolar teeth extraction for orthodontic treatment
• Poor oral hygiene
• Non-functioning premolar teeth to be included
• Patients having systemical disorders, periodontal diseases or allergic reactions to dental materials

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Interventions

Adhesives

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ege University Faculty of Dentistry

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 20, 2016
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04