Clinical Trials Directory

Trials / Completed

CompletedNCT04578717

Bioactive Glass Air-abrasion and Non-carious Cervical Lesions

Effect of Surface Pre-conditioning With Bioactive Glass Air-abrasion on the Clinical Performance of Composite Restorations in Non-carious Cervical Lesions

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Damascus University · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Accepted

Summary

Evaluating the clinical behavior of composite restorations in NCCLs when the surface is pre-conditioned using bioactive glass air-abrasion has not been reported in the dental literature. This double-blinded randomised clinical trial evaluated the effect of surface pre-conditioning with bioactive air-abrasion on the performance of composite restorations in NCCLs placed using etch\&rinse and self-etch adhesive systems.

Detailed description

15 Patients with 100 teeth meeting the inclusion criteria were enrolled in this study. NCCLs characteristics were evaluated and recorded before the placement of restorations. The cavity dimensions in millimeters (height, width, and depth), the cavity geometry (labeled at \>45°, 45° - 90°, 90° - 135°, and \<135°), the degree of dentin sclerosis , the existence of attrition facets, and the existence of spontaneous sensitivity were measured and recorded in the patient's form. The preoperative sensitivity was also evaluated by applying air from a dental syringe placed 2 cm from the tooth surface for 10 seconds. NCCLs meeting the inclusion criteria were randomly assigned into four experimental groups (n=25); A: air-abrasion + etch\&rinse, B: air-abrasion + self-etch, C: etch\&rinse and D: self-etch. Prophylaxis was conducted using a rubber cup with pumice and water. The color of the composite was selected using VITA classical shade guide before applying local anesthesia with Lidocaine 2% with 1:100000 adrenaline. Retraction chord was inserted into the gingival sulcus with the aid of a blunt spatula without excessive pressure to the periodontium. Teeth were isolated with rubberdam. No preparation or beveling of cavosurface margins was performed to the NCCLs. In air-abrasion groups, a clinical air-abrasion unit was used to pre-condition the NCCLs with bioactive glass 45S5 powder for 10 sec. The operating parameters were; air pressure, 20 psi; powder particles size, 20 µm; nozzle angle, 90◦; nozzle-lesion distance, 5 mm and the internal nozzle diameter, 900 µm For the etch\&rinse groups, enamel and dentine were etched using 37% Phosphoric acid for 30 sec and 15 sec respectively. NCCLs were rinsed thoroughly for 20 sec to remove the acid. Excess water was removed using a cotton pellet to leave a moist dentine surface. One coat of bonding adhesive was gently scrubbed on the entire enamel and dentin surface for 20 sec, air dried for 5 sec and light cured for 10 sec using LED curing light ( output \>800mW/cm2). In self-etch groups, the bonding adhesive was applied to enamel and dentine for 20 sec with agitation, gently air dried and light cured for 10 sec. NCCLs were restored using FiltekTM Z250 XT resin composite, placed in 2 mm increments and light cured for 20 s per increment. Final contour was achieved with a fine diamond rotary instrument followed by finishing and polishing using Optrapol polishing kit . Clinical evaluation was conducted by two trained and calibrated examiners. The examiners and patients were blinded to the group assignment, in accordance with the double-blinding randomized clinical trial design. Each restoration was evaluated at baseline (one week after restoration placement), 3 months and 6 months. This evaluation was conducted according to World Federation criteria (FDI)

Conditions

Interventions

TypeNameDescription
PROCEDUREAir-abrasionA clinical air-abrasion unit was used to pre-condition the NCCLs with bioactive glass 45S5 powder for 10 sec. The operating parameters were; air pressure, 20 psi; powder particles size, 20 µm; nozzle angle, 90◦; nozzle-lesion distance, 5 mm and the internal nozzle diameter, 900 µm
PROCEDUREAdhesive application - Etch&rinseEnamel and dentine were etched using 37% Phosphoric acid for 30 sec and 15 sec respectively. NCCLs were rinsed thoroughly for 20 sec to remove the acid. Excess water was removed using a cotton pellet to leave a moist dentine surface. One coat of bonding adhesive was gently scrubbed on the entire enamel and dentin surface for 20 sec, air dried for 5 sec and light cured for 10 sec using LED curing light. The light intensity of curing unit was calibrated daily using curing radiometer .
BIOLOGICALAdhesive application - Self-etchThe bonding adhesive was applied to enamel and dentine for 20 sec with agitation, gently air dried and light cured for 10 sec.

Timeline

Start date
2018-10-01
Primary completion
2019-08-01
Completion
2020-02-01
First posted
2020-10-08
Last updated
2020-10-20

Locations

1 site across 1 country: Syria

Source: ClinicalTrials.gov record NCT04578717. Inclusion in this directory is not an endorsement.