Bioactive Glass Air-abrasion and Non-carious Cervical Lesions

Cervical Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578717
• Other study ID #: 3479-2018
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: October 2020
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Be at least 19 years old, be in good general and oral health and be available for follow-up visits

• NCCLs inclusion criteria are; at least 1 mm deep, involving enamel and dentin of vital teeth.

Exclusion Criteria:

• Chronic therapeutic drug history, rampant uncontrolled caries, periodontal disease, pregnancy or lactation, orthodontic appliance use, evidence of xerostomia, evidence of severe bruxing, clenching or TMD, and known sensitivity to acrylates or related materials.

• NCCLs exclusion criteria are; teeth with periapical pathology, symptoms of pulpal pathology, non-vital or previous root canal therapy, previous pulp capping and tooth hypersensitivity

Related Conditions & MeSH terms

• Cervical Lesion
• Uterine Cervical Diseases

Intervention

Procedure:
• Air-abrasion
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
• Adhesive application - Etch&rinse
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. The light intensity of curing unit was calibrated daily using curing radiometer .

Biological:
• Adhesive application - Self-etch
The bonding adhesive was applied to enamel and dentine for 20 sec with agitation, gently air dried and light cured for 10 sec.

Locations

Country	Name	City	State
Syrian Arab Republic	Restorative Dentistry, Faculty of Dental Medicine, Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (9)

de Paula EA, Tay LY, Kose C, Mena-Serrano A, Reis A, Perdigão J, Loguercio AD. Randomized clinical trial of four adhesion strategies in cervical lesions: 12-month results. Int J Esthet Dent. 2015 Spring;10(1):122-45. — View Citation

Häfer M, Jentsch H, Haak R, Schneider H. A three-year clinical evaluation of a one-step self-etch and a two-step etch-and-rinse adhesive in non-carious cervical lesions. J Dent. 2015 Mar;43(3):350-61. doi: 10.1016/j.jdent.2014.12.009. Epub 2014 Dec 23. — View Citation

Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29. — View Citation

Loguercio AD, Luque-Martinez IV, Fuentes S, Reis A, Muñoz MA. Effect of dentin roughness on the adhesive performance in non-carious cervical lesions: A double-blind randomized clinical trial. J Dent. 2018 Feb;69:60-69. doi: 10.1016/j.jdent.2017.09.011. Epub 2017 Sep 27. — View Citation

Perdigão J, Kose C, Mena-Serrano AP, De Paula EA, Tay LY, Reis A, Loguercio AD. A new universal simplified adhesive: 18-month clinical evaluation. Oper Dent. 2014 Mar-Apr;39(2):113-27. doi: 10.2341/13-045-C. Epub 2013 Jun 26. — View Citation

Sauro S, Watson TF, Thompson I, Banerjee A. One-bottle self-etching adhesives applied to dentine air-abraded using bioactive glasses containing polyacrylic acid: an in vitro microtensile bond strength and confocal microscopy study. J Dent. 2012 Nov;40(11):896-905. doi: 10.1016/j.jdent.2012.07.004. Epub 2012 Jul 20. — View Citation

Schroeder M, Correa IC, Bauer J, Loguercio AD, Reis A. Influence of adhesive strategy on clinical parameters in cervical restorations: A systematic review and meta-analysis. J Dent. 2017 Jul;62:36-53. doi: 10.1016/j.jdent.2017.05.006. Epub 2017 May 8. Review. — View Citation

van Dijken JW. Clinical evaluation of three adhesive systems in class V non-carious lesions. Dent Mater. 2000 Jul;16(4):285-91. — View Citation

Zanatta RF, Silva TM, Esper M, Bresciani E, Gonçalves S, Caneppele T. Bonding Performance of Simplified Adhesive Systems in Noncarious Cervical Lesions at 2-year Follow-up: A Double-blind Randomized Clinical Trial. Oper Dent. 2019 Sep/Oct;44(5):476-487. doi: 10.2341/18-049-C. Epub 2019 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Restoration Retention Rate and Integrity	The unabbreviated scale title: Restoration Retention Rate and Integrity Scale; The minimum and maximum values: 1, 5; Higher scores mean a worse outcome.; Restoration retained, no fractures/ cracks; Small hairline crack; Two or larger hairline cracks and/or chipping (not affecting the marginal integrity); Chipping fractures which damage marginal quality; Partial or complete loss of restoration	Baseline (one week after restoration placement), Change from Baseline rate of retention at 3 months, Change from Baseline rate of retention at 6 months
Secondary	Change in Marginal Adaptation	1. Harmonious outline, no gaps, no discoloration 2.1 Marginal gap (50 µm). 2.2 Small marginal fracture. 3.1 Gap <150 µm not removable 3.2 Several small enamel or dentin fractures 4.1 Gap >250 µm or dentin/base exposed. 4.2 chip fracture damaging margins 4.3 Notable enamel or dentin wall fracture 5. Filing is loose but in situ	Baseline (one week after restoration placement), Change from Baseline marginal adaptation at 3 months, Change from Baseline marginal adaptation at 6 months
Secondary	Change in Postoperative Hypersensitivity	This will be assessed using Dentine Hypersensitivity Scale difference from the baseline values. Tooth sensitivity score was assessed by applying air from a dental syringe placed 2-cm from the tooth surface for 10 seconds.; The unabbreviated scale title: Dentine Postoperative Hypersensitivity Scale; The minimum and maximum values: 1, 5; Higher scores mean a worse outcome.; Subject does not respond to air stimulus,; Low hypersensitivity for a limited period of time,; 3.1. Premature / slightly more intense; 3.2. Delayed/weak sensitivity; no subjective complaints, no treatment needed.; 4.1. Premature/ very intense; 4.2. Extremely delayed/weak with subjective complaints; 4.3. Negative Sensitivity Intervention necessary but not replacement.; 5. Very intense, acute pulpitis or non-vital. Endodontic treatment is necessary and restoration has to be replaced.	Baseline (one week after restoration placement), Change from Baseline postoperative hypersensitivity at 3 months, Change from Baseline postoperative hypersensitivity at 6 months
Secondary	Change in Recurrence of Caries	1. No secondary or primary caries 2. Very small and localized demineralization. No operative treatment required 3. Larger areas of demineralization, but only preventive measures necessary (dentin not exposed) 4. Caries with cavitation (localized and accessible and can be repaired) 5. Deep secondary caries or exposed dentin that is not accessible for repair of restoration	Baseline (one week after restoration placement), Change from Baseline recurrence of caries at 3 months, Change from Baseline recurrence of caries at 6 months
Secondary	Change in Marginal Staining	The unabbreviated scale title: Marginal Staining Scale; The minimum and maximum values: 1, 5; Higher scores mean a worse outcome.; No marginal staining; Minor marginal staining, easily removable by polishing; Moderate marginal staining, not esthetically unacceptable; Pronounced marginal staining; major intervention necessary for improvement; Deep marginal staining not acceptable for intervention	Baseline (one week after restoration placement), Change from Baseline staining margin at 3 months, Change from Baseline staining margin at 6 months