Bioactive Glass Air-abrasion and Non-carious Cervical Lesions

NCT04578717 | Completed

• 1 other identifier: 3479-2018
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Lesion

Keywords

Non-carious cervical lesions (NCCLs); Air-abrasion; Bioactive glass; Composite restorations; Adhesive

Outcome Measures

Primary Outcomes (1)

• 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. 1. Restoration retained, no fractures/ cracks 2. Small hairline crack 3. Two or larger hairline cracks and/or chipping (not affecting the marginal integrity) 4. Chipping fractures which damage marginal quality 5. 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 Outcomes (4)

• Change in Marginal Adaptation

  Baseline (one week after restoration placement), Change from Baseline marginal adaptation at 3 months, Change from Baseline marginal adaptation at 6 months

• Change in Postoperative Hypersensitivity

  Baseline (one week after restoration placement), Change from Baseline postoperative hypersensitivity at 3 months, Change from Baseline postoperative hypersensitivity at 6 months

• Change in Recurrence of Caries

  Baseline (one week after restoration placement), Change from Baseline recurrence of caries at 3 months, Change from Baseline recurrence of caries at 6 months

• Change in Marginal Staining

  Baseline (one week after restoration placement), Change from Baseline staining margin at 3 months, Change from Baseline staining margin at 6 months

Study Arms (4)

Air-abrasion + Etch & rinse adhesive

EXPERIMENTAL

Air-abrasion unit was used to pre-condition the NCCLs with bioactive glass 45S5 followed by etch\&rinse adhesive application 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

Procedure: Air-abrasion; Procedure: Adhesive application - Etch&rinse

Air-abrasion + Self-etch adhesive

EXPERIMENTAL

Air-abrasion unit was used to pre-condition the NCCLs with bioactive glass 45S5 followed by self-etch adhesive application which was applied to enamel and dentine for 20 sec with agitation, gently air dried and light cured for 10 sec.

Procedure: Air-abrasion; Biological: Adhesive application - Self-etch

Etch & rinse adhesive

EXPERIMENTAL

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

Procedure: Adhesive application - Etch&rinse

Self-etch adhesive

EXPERIMENTAL

The bonding adhesive was applied to enamel and dentine for 20 sec with agitation, gently air dried and light cured for 10 sec.

Biological: Adhesive application - Self-etch

Interventions

Air-abrasion PROCEDURE

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

Also known as: surface pre-conditioning

Air-abrasion + Etch & rinse adhesive; Air-abrasion + Self-etch adhesive

Adhesive application - Etch&rinse PROCEDURE

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 .

Also known as: Bonding

Air-abrasion + Etch & rinse adhesive; Etch & rinse adhesive

Adhesive application - Self-etch BIOLOGICAL

The bonding adhesive was applied to enamel and dentine for 20 sec with agitation, gently air dried and light cured for 10 sec.

Also known as: Bonding

Air-abrasion + Self-etch adhesive; Self-etch adhesive

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Restorative Dentistry, Faculty of Dental Medicine, Damascus University

Damascus, Syria

Location

Related Publications (9)

• Zanatta RF, Silva TM, Esper M, Bresciani E, Goncalves 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.

  PMID: 30702405 BACKGROUND

• 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.

  PMID: 26231300 BACKGROUND

• Hafer 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.

  PMID: 25541248 BACKGROUND

• Perdigao 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.

  PMID: 23802645 BACKGROUND

• Paula EA, Tay LY, Kose C, Mena-Serrano A, Reis A, Perdigao J, Loguercio AD. Randomized clinical trial of four adhesion strategies in cervical lesions: 12-month results. Int J Esthet Dent. 2015 Spring;10(1):122-145.

  PMID: 25625130 BACKGROUND

• 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.

  PMID: 28495559 BACKGROUND

• van Dijken JW. Clinical evaluation of three adhesive systems in class V non-carious lesions. Dent Mater. 2000 Jul;16(4):285-91. doi: 10.1016/s0109-5641(00)00019-1.

  PMID: 10831784 BACKGROUND

• Loguercio AD, Luque-Martinez IV, Fuentes S, Reis A, Munoz 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.

  PMID: 28962842 BACKGROUND

• 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.

  PMID: 22819812 BACKGROUND

MeSH Terms

Interventions

Air Abrasion, Dental

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Hussam Milly, Phd

  Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Clinical evaluation of NCCLs restorations was conducted by two trained and calibrated examiners.The examiners and patients were blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A hundred teeth with 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.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 8, 2020
• Study Start: October 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: February 1, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)