Cervical LesionNCT04578717
Bioactive Glass Air-abrasion and Non-carious Cervical Lesions
A study testing Air-abrasion, Adhesive application - Etch&rinse and Adhesive application - Self-etch in people with Cervical Lesion, run by Damascus University at 1 site in Syria.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Lesion
- What is being tested?
- Air-abrasion, Adhesive application - Etch&rinse and Adhesive application - Self-etch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSyria
- Study dates
- 1 Oct 2018to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Syria1 site
Restorative Dentistry, Faculty of Dental Medicine, Damascus University
Damascus
About this study
Official title: Effect of Surface Pre-conditioning With Bioactive Glass Air-abrasion on the Clinical Performance of Composite Restorations in 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.
Read the 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
- Cervical Lesion
- Being tested
- Air-abrasion, Adhesive application - Etch&rinse, Adhesive application - Self-etch
- Keywords
- Non-carious cervical lesions (NCCLs), Air-abrasion, Bioactive glass, Composite restorations, Adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-abrasionProcedure or surgery
Also called surface pre-conditioning
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&rinseProcedure or surgery
Also called Bonding
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 .
Adhesive application - Self-etchBiological
Also called Bonding
The bonding adhesive was applied to enamel and dentine for 20 sec with agitation, gently air dried and light cured for 10 sec.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: 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. Receives: Biological: Adhesive application - Self-etch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- 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
Measured: 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
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.
Measured: 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
- 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
Measured: 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
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
Measured: Baseline (one week after restoration placement), Change from Baseline staining margin at 3 months, Change from Baseline staining margin at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2018
- Primary completion1 Aug 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cervical LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hussam Milly, Phd, Study director, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578717
- Sponsor's protocol ID
- 3479-2018
- Status last verified
- Oct 2020
- First submitted
- 23 Sep 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30702405Lawson 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.
PubMed 26231300Hafer 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.
PubMed 25541248Perdigao 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.
PubMed 23802645Paula 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.
PubMed 25625130Schroeder 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.
PubMed 28495559van 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.
PubMed 10831784Loguercio 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.
PubMed 28962842Sauro 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.
PubMed 22819812
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surface Pre-conditioning With Bioactive Glass Air-abrasion on the Clinical Performance of Composite Restorations in Non-carious Cervical Lesions
- ClinicalTrials.gov ID
- NCT04578717
- Acronym / sponsor ID
- 3479-2018
- Conditions
- Cervical Lesion
- Keywords
- Non-carious cervical lesions (NCCLs), Air-abrasion, Bioactive glass, Composite restorations, Adhesive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Air-abrasion + Etch & rinse adhesive | Experimental | Procedure: Air-abrasion, Procedure: Adhesive application - Etch&rinseAir-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 | Experimental | Procedure: Air-abrasion, Biological: Adhesive application - Self-etchAir-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. |
| Etch & rinse adhesive | Experimental | Procedure: Adhesive 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 |
| Self-etch adhesive | Experimental | Biological: Adhesive 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air-abrasionAlso: surface pre-conditioningA 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 | Procedure or surgery | Air-abrasion + Etch & rinse adhesive, Air-abrasion + Self-etch adhesive |
| Adhesive application - Etch&rinseAlso: BondingEnamel 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 . | Procedure or surgery | Air-abrasion + Etch & rinse adhesive, Etch & rinse adhesive |
| Adhesive application - Self-etchAlso: BondingThe bonding adhesive was applied to enamel and dentine for 20 sec with agitation, gently air dried and light cured for 10 sec. | Biological | Air-abrasion + Self-etch adhesive, Self-etch adhesive |
Primary outcome
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. 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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Background: PubMed 30702405Zanatta 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.
- Background: PubMed 26231300Lawson 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.
- Background: PubMed 25541248Hafer 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.
- Background: PubMed 23802645Perdigao 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.
- Background: PubMed 25625130Paula 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.
- Background: PubMed 28495559Schroeder 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.
- Background: PubMed 10831784van 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.
- Background: PubMed 28962842Loguercio 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.
- Background: PubMed 22819812Sauro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussam Milly, Phd study director
Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air-abrasion, Adhesive application - Etch&rinse and Adhesive application - Self-etch in people with Cervical Lesion, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578717, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.