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Completed

NCT Number: NCT04578717

Bioactive Glass Air-abrasion and Non-carious Cervical Lesions

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Restorative Dentistry, Faculty of Dental Medicine, Damascus University

Damascus, Syria

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: surface pre-conditioning

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 .

Other names: Bonding

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.

Other names: Bonding

Primary outcomes

  1. Change in Restoration Retention Rate and Integrity

    Time frame: Baseline (one week after restoration placement), Change from Baseline rate of retention at 3 months, Change from Baseline rate of retention at 6 months

    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

Secondary outcomes

  1. Change in Marginal Adaptation

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

    • 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
  2. Change in Postoperative Hypersensitivity

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

    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.

    • Very intense, acute pulpitis or non-vital. Endodontic treatment is necessary and restoration has to be replaced.
  3. Change in Recurrence of Caries

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

    • 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
  4. Change in Marginal Staining

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

    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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 8, 2020
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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