Bioactive Glass Air-abrasion and Non-carious Cervical Lesions
- Conditions
- Cervical Lesion
- Interventions
- Procedure: Air-abrasionBiological: Adhesive application - Self-etchProcedure: Adhesive application - Etch&rinse
- Registration Number
- NCT04578717
- Lead Sponsor
- Damascus University
- 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.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Air-abrasion + Self-etch adhesive Adhesive application - Self-etch 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. Air-abrasion + Etch & rinse adhesive Air-abrasion 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 Air-abrasion + Etch & rinse adhesive Adhesive application - Etch&rinse 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 Air-abrasion + Self-etch adhesive Air-abrasion 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. Self-etch adhesive 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. Etch & rinse adhesive 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
- Primary Outcome Measures
Name Time Method Change in Restoration Retention Rate and Integrity 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.
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
- Secondary Outcome Measures
Name Time Method 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 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
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 The unabbreviated scale title: Marginal Staining Scale
The minimum and maximum values: 1, 5
Higher scores mean a worse outcome.
1. No marginal staining
2. Minor marginal staining, easily removable by polishing
3. Moderate marginal staining, not esthetically unacceptable
4. Pronounced marginal staining; major intervention necessary for improvement
5. Deep marginal staining not acceptable for interventionChange 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 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.
1. Subject does not respond to air stimulus,
2. 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.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 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
Trial Locations
- Locations (1)
Restorative Dentistry, Faculty of Dental Medicine, Damascus University
🇸🇾Damascus, Syrian Arab Republic