RepairNCT05500430
Evaluation of Air Abrasion Surface Pretreatment in the Repairing Capacity of Defective Composite Restoration
A study testing Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) in people with Repair, run by Cairo University at 1 site in Egypt.
Trial summary
This study is conducted to compare the efficacy of surface pretreatment using air abrasion sandblasting aluminum oxide particles (Al2O3) versus not pretreatment in the repair capacity of defective composite restoration indicated for repair. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Repair
- What is being tested?
- Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2022to 1 Feb 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Co-operative patients approving to participate in the trial.
- patient with occlusal defects class I or class II composite resin restorations indicated for repair.
Who cannot join
- Allergic history concerning methacrylate.
- Rampant caries.
- Disabilities patient
- Pregnancy
- Heavy smoking.
- Xerostomia.
Show all 9Show fewer
- Lack of compliance.
- Evidence of parafunctional habits.
- Temporomandibular joint disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Bioactive Injectable Hybrid Resin Composite Restoration With or Without Air Abrasion Surface Pretreatment in the Repairing Capacity of Defective Composite Restoration, A Randomized Controlled Clinical Trial
This study is conducted to compare the efficacy of surface pretreatment using air abrasion sandblasting aluminum oxide particles (Al2O3) versus not pretreatment in the repair capacity of defective composite restoration indicated for repair.
Read the detailed description
First the rationale for the repair, rather than the replacement of defective direct composite restorations proved a less invasive procedure with decreased tooth loss avoiding weakening and overtreatment of tooth. Less traumatic or stressful than replacement for patients with good acceptance; Increased longevity of the restoration; Reduction of potentially harmful effects on the dental pulp and Less risk of iatrogenic damage to adjacent teeth.
Secondary using surface treatment strategies aim to prepare a clean surface with high surface energy to provide better wettability with adequate surface roughness and surface area by removing the superficial layer of the aged composite which lead to increase integrity between old and new resin restoration.
- Conditions
- Repair
- Being tested
- Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK)
- Keywords
- repair, defective restoration, sandblasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK)Device
Also called sandblasting
Air abrasion sandblasting aluminum oxide particles (Al2O3) Aqua Care single (London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautiful Flow Plus X F00 (Shofu, Japan).
| Study group | Role | What they receive |
|---|---|---|
| surface pretreatment sandblasting | Experimental | Air abrasion sandblasting aluminum oxide particles (Al2O3) Aqua Care single (London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautiful Flow Plus X F00 (Shofu, Japan).
The surface treatment for aged composite will be applied according to manufacturer instructions.
Repairing with bioactive injectable composite, Beautiful Flow Plus X F00(Shofu, Japan) The material will be applied according to manufacturer instructions. After shade selection incremental insertion in layers not exceeding 2 mm and light curing for 10 sec using 3M Eliper curing unite (Elipar Deepcure-S, 3M). Receives: Device: Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) |
| Repairing with conventional nanohybrid composite | Active comparator | The nanohybrid resin composite will be applied to the the cavity using the conventional incremental technique according to manufacturer instructions. Receives: Device: Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical performance
Change in the clinical performance Measured using modified USPHS criteria for clinical evaluation of restoration failure.
Measuring Unit:
Scoring system (Ordinal):
- Alfa
- Bravo
- Charlie
- Delta
Measured: Change from the baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start20 Jan 2022
- Primary completion20 Oct 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RepairStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Abdel-Aty hassan, Cairo University
- Investigators
- heba hamza, Professor, Study director, heba.hamza@dentistry.cu.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500430
- Sponsor's protocol ID
- repair defective restoration
- Status last verified
- Feb 2024
- First submitted
- 11 Aug 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bioactive Injectable Hybrid Resin Composite Restoration With or Without Air Abrasion Surface Pretreatment in the Repairing Capacity of Defective Composite Restoration, A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05500430
- Acronym / sponsor ID
- repair defective restoration
- Conditions
- Repair
- Keywords
- repair, defective restoration, sandblasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 15 Aug 2022 (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.
This study is conducted to compare the efficacy of surface pretreatment using air abrasion sandblasting aluminum oxide particles (Al2O3) versus not pretreatment in the repair capacity of defective composite restoration indicated for repair.
Detailed description
First the rationale for the repair, rather than the replacement of defective direct composite restorations proved a less invasive procedure with decreased tooth loss avoiding weakening and overtreatment of tooth. Less traumatic or stressful than replacement for patients with good acceptance; Increased longevity of the restoration; Reduction of potentially harmful effects on the dental pulp and Less risk of iatrogenic damage to adjacent teeth.
Secondary using surface treatment strategies aim to prepare a clean surface with high surface energy to provide better wettability with adequate surface roughness and surface area by removing the superficial layer of the aged composite which lead to increase integrity between old and new resin restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surface pretreatment sandblasting | Experimental | Device: Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK)Air abrasion sandblasting aluminum oxide particles (Al2O3) Aqua Care single (London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautiful Flow Plus X F00 (Shofu, Japan). The surface treatment for aged composite will be applied according to manufacturer instructions. Repairing with bioactive injectable composite, Beautiful Flow Plus X F00(Shofu, Japan) The material will be applied according to manufacturer instructions. After shade selection incremental insertion in layers not exceeding 2 mm and light curing for 10 sec using 3M Eliper curing unite (Elipar Deepcure-S, 3M). |
| Repairing with conventional nanohybrid composite | Active comparator | Device: Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK)The nanohybrid resin composite will be applied to the the cavity using the conventional incremental technique according to manufacturer instructions. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Co-operative patients approving to participate in the trial.
- patient with occlusal defects class I or class II composite resin restorations indicated for repair.
Key exclusion criteria (9 listed)
- Allergic history concerning methacrylate.
- Rampant caries.
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 abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK)Also: sandblastingAir abrasion sandblasting aluminum oxide particles (Al2O3) Aqua Care single (London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautiful Flow Plus X F00 (Shofu, Japan). | Device | Repairing with conventional nanohybrid composite, surface pretreatment sandblasting |
Primary outcome
Change in the clinical performance
Time frame: Change from the baseline at 12 months
Change in the clinical performance Measured using modified USPHS criteria for clinical evaluation of restoration failure. Measuring Unit: Scoring system (Ordinal): * Alfa * Bravo * Charlie * Delta
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 7 Feb 2024.
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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.
heba hamza, Professor study director
heba.hamza@dentistry.cu.edu.eg
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 sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) in people with Repair, run by Cairo University at 1 site in Egypt.
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 9 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 7 Feb 2024. 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 Egypt. 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 the clinical performance (time frame: Change from the baseline at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.