Defective Composite RestorationsNCT06005571
Effect of Silane Coupling on the Clinical Performance of Repaired Composite
A study testing composite restoration repair by traditional acid etch treatment procedure and adhesive., Composite restoration repair by acid etching, silane solution application, and then adhesive. and Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive. in people with Defective Composite Restorations, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Research Problem : Advances in adhesive technologies have introduced several surface treatment concepts that enable the clinician to adhere resin-based composite restorations onto new composite materials. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Defective Composite Restorations
- What is being tested?
- composite restoration repair by traditional acid etch treatment procedure and adhesive., Composite restoration repair by acid etching, silane solution application, and then adhesive. and Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteJordan
- Study dates
- 10 Mar 2022to 15 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Deciduous tooth
- Sustained dentin hypersensitivity
- Irreversible pulpitis , necrotic, or inadequately-treated endodontic teeth
- Grossly defective composite restorations that were indicated for replacement.
- Teeth with compromised periodontal status.
- Patients with poor oral hygiene
Who cannot join
- Patients older than 18 years.
- Asymptomatic restored premolars or molars.
- Vital or endodontically treated teeth
- Patients with localized, marginal, anatomical deficiencies and/or carious lesions adjacent to composite restorations or esthetically unpleasant restorations.
- Teeth with marginal gingivitis but healthy periodontium.
- Tooth in normal occlusion with antagonist and at least one adjacent tooth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Silane Coupling Treatment on the Clinical Performance of Direct Repaired Resin-based Composite: A Randomized Controlled Trial.
Research Problem : Advances in adhesive technologies have introduced several surface treatment concepts that enable the clinician to adhere resin-based composite restorations onto new composite materials. The service life of faulty direct composite restorations can be prolonged by composite repair wherein durable adhesion between old and new resin-based composite materials is established.
Read the detailed description
Objectives : A randomized controlled clinical trial was designed to apply the latest results of evidence-based in vitro studies regarding resin-based repair protocol. The study aimed to assess the effect of adding silane coupling agent as a separate step on the clinical performance of repaired composite restorations and compare the results with those of using the usual etch and bond protocol.
Materials and Methods : 45 patients were recruited for this study from patients attending the restorative dentistry clinics for postgraduate students, Jordan University of Science and Technology. Each patient had at least two defected posterior composite restorations that are indicated for repair. With this selection, 116 restorations with localized anatomical deficiencies and/or secondary caries were randomly assigned into three groups according to the type of surface treatment each tooth will receive before the application of the new composite material (Filtek Z250,3M,USA). The teeth in the control group (n = 45): were treated with 37% phosphoric acid etching and conventional one step adhesive (Single Bond,3M,USA). In the Silane-Adhesive group (n = 26): teeth were treated with acid etching and silane coupling agent application (Bis-silane) prior to adhesive bond (Adper single bond). In the Sandblast-Silane-Adhesive group (n = 45): teeth were treated with intra-oral sandblasting and silane coupling agent application (Bis-silane) prior to (Adper Single Bond). The reason of repair, age of old restorations and the location of the restoration-repair interfaces were recorded for every failed restorations. Two examiners followed-up and evaluated the restoration quality after an average of 6 months using modified USPHS criteria. The results of clinical performance were assessed using Chi-square test.
- Conditions
- Defective Composite Restorations
- Being tested
- composite restoration repair by traditional acid etch treatment procedure and adhesive., Composite restoration repair by acid etching, silane solution application, and then adhesive., Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.
- Keywords
- Silane, Sandblasting of tooth surfaces, Clinical trial, dentine bonding, Composite repair, defective restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
composite restoration repair by traditional acid etch treatment procedure and adhesive.Procedure or surgery
Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid and adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity.
Composite restoration repair by acid etching, silane solution application, and then adhesive.Procedure or surgery
Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity.
Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.Procedure or surgery
Recurrent caries surrounding the defective restoration was removed, the old restoration surface were sandblasted, and the tooth and restoration surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was added to repair the old restoration and restore the carious cavity.
| Study group | Role | What they receive |
|---|---|---|
| Control: traditional acid etch treatment group | Active comparator | Traditional acid etching to the tooth and old restoration surfaces and then adhesive application. Receives: Procedure: composite restoration repair by traditional acid etch treatment procedure and adhesive. |
| Silane-Adhesive treatment group | Experimental | Acid cid etching of prepared tooth tissues and old restoration surfaces, silane solution application, and then adhesive application. Receives: Procedure: Composite restoration repair by acid etching, silane solution application, and then adhesive. |
| Sandblast-Silane-Adhesive treatment group | Experimental | First sandblasting the old composite filling surfaces, then acid etching of prepared tooth tissues the restoration, then silane application followed by adhesive application. Receives: Procedure: Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the quality of the repaired restoration retention, colour match, marginal discoloration, marginal adaptation, anatomical form and surface roughness.
Clinical examination and evaluation of the restoration quality according to the United States Public Health Service (USPHS) criteria as Alpha, Bravo and Charlie. Alpha scores mean a better outcome and Charlie scores mean worse outcome.
Measured: 2 years
Secondary outcomes (1)
The presence of postoperative sensitivity.
Patients record their sensitivity in treated teeth and score its intensity on visual analogue scale (VAS) which was divided into 10 digits from 0 to 10 where scores from 0 to less than 5 mean "bearable sesitivity" and scores from 5 to10 mean "unbearable sensitivy" outcome.
Measured: 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start10 Mar 2022
- Primary completion30 Sep 2022
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Defective Composite RestorationsStudies 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
- Three groups of patients were randomly assigned to three different treatment protocols of defective composite restoration repair.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Zakereyya Albashaireh, Jordan University of Science and Technology
- Investigators
- Zakereyya Albashaireh, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005571
- Sponsor's protocol ID
- 20220082
- Status last verified
- Mar 2025
- First submitted
- 18 Jun 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A consent has to be obtained from the faculty of graduate studies for sharing data as data form part of graduate students thesis.
Publications
Albashaireh ZSM, Maghaireh GA, Alsaafeen HN. Effects of silane coupling treatment on the clinical performance of direct repaired resin-based composite (RBC) restorations with or without prior surface sandblasting: A randomized controlled trial. J Dent. 2023 Dec;139:104740. doi: 10.1016/j.jdent.2023.104740. Epub 2023 Oct 8.
PubMed 37816489
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Silane Coupling Treatment on the Clinical Performance of Direct Repaired Resin-based Composite: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06005571
- Acronym / sponsor ID
- 20220082
- Conditions
- Defective Composite Restorations
- Keywords
- Silane, Sandblasting of tooth surfaces, Clinical trial, dentine bonding, Composite repair, defective restorations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 22 Aug 2023 (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.
Research Problem : Advances in adhesive technologies have introduced several surface treatment concepts that enable the clinician to adhere resin-based composite restorations onto new composite materials. The service life of faulty direct composite restorations can be prolonged by composite repair wherein durable adhesion between old and new resin-based composite materials is established.
Detailed description
Objectives : A randomized controlled clinical trial was designed to apply the latest results of evidence-based in vitro studies regarding resin-based repair protocol. The study aimed to assess the effect of adding silane coupling agent as a separate step on the clinical performance of repaired composite restorations and compare the results with those of using the usual etch and bond protocol.
Materials and Methods : 45 patients were recruited for this study from patients attending the restorative dentistry clinics for postgraduate students, Jordan University of Science and Technology. Each patient had at least two defected posterior composite restorations that are indicated for repair. With this selection, 116 restorations with localized anatomical deficiencies and/or secondary caries were randomly assigned into three groups according to the type of surface treatment each tooth will receive before the application of the new composite material (Filtek Z250,3M,USA). The teeth in the control group (n = 45): were treated with 37% phosphoric acid etching and conventional one step adhesive (Single Bond,3M,USA). In the Silane-Adhesive group (n = 26): teeth were treated with acid etching and silane coupling agent application (Bis-silane) prior to adhesive bond (Adper single bond). In the Sandblast-Silane-Adhesive group (n = 45): teeth were treated with intra-oral sandblasting and silane coupling agent application (Bis-silane) prior to (Adper Single Bond). The reason of repair, age of old restorations and the location of the restoration-repair interfaces were recorded for every failed restorations. Two examiners followed-up and evaluated the restoration quality after an average of 6 months using modified USPHS criteria. The results of clinical performance were assessed using Chi-square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups of patients were randomly assigned to three different treatment protocols of defective composite restoration repair.
| Arm | Type | Receives |
|---|---|---|
| Control: traditional acid etch treatment group | Active comparator | Procedure: composite restoration repair by traditional acid etch treatment procedure and adhesive.Traditional acid etching to the tooth and old restoration surfaces and then adhesive application. |
| Silane-Adhesive treatment group | Experimental | Procedure: Composite restoration repair by acid etching, silane solution application, and then adhesive.Acid cid etching of prepared tooth tissues and old restoration surfaces, silane solution application, and then adhesive application. |
| Sandblast-Silane-Adhesive treatment group | Experimental | Procedure: Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.First sandblasting the old composite filling surfaces, then acid etching of prepared tooth tissues the restoration, then silane application followed by adhesive application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Deciduous tooth
- Sustained dentin hypersensitivity
- Irreversible pulpitis , necrotic, or inadequately-treated endodontic teeth
- Grossly defective composite restorations that were indicated for replacement.
- Teeth with compromised periodontal status.
Key exclusion criteria (6 listed)
- Patients older than 18 years.
- Asymptomatic restored premolars or molars.
- Vital or endodontically treated teeth
- Patients with localized, marginal, anatomical deficiencies and/or carious lesions adjacent to composite restorations or esthetically unpleasant restorations.
- Teeth with marginal gingivitis but healthy periodontium.
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 |
|---|---|---|
| composite restoration repair by traditional acid etch treatment procedure and adhesive.Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid and adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity. | Procedure or surgery | Control: traditional acid etch treatment group |
| Composite restoration repair by acid etching, silane solution application, and then adhesive.Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity. | Procedure or surgery | Silane-Adhesive treatment group |
| Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.Recurrent caries surrounding the defective restoration was removed, the old restoration surface were sandblasted, and the tooth and restoration surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was added to repair the old restoration and restore the carious cavity. | Procedure or surgery | Sandblast-Silane-Adhesive treatment group |
Primary outcome
Assessment of the quality of the repaired restoration retention, colour match, marginal discoloration, marginal adaptation, anatomical form and surface roughness.
Time frame: 2 years
Clinical examination and evaluation of the restoration quality according to the United States Public Health Service (USPHS) criteria as Alpha, Bravo and Charlie. Alpha scores mean a better outcome and Charlie scores mean worse outcome.
1 secondary outcome
The presence of postoperative sensitivity.
Time frame: 2 years.
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 6 Mar 2025.
- Derived from this study: PubMed 37816489Albashaireh ZSM, Maghaireh GA, Alsaafeen HN. Effects of silane coupling treatment on the clinical performance of direct repaired resin-based composite (RBC) restorations with or without prior surface sandblasting: A randomized controlled trial. J Dent. 2023 Dec;139:104740. doi: 10.1016/j.jdent.2023.104740. Epub 2023 Oct 8.
- Individual participant dataSharing planned: No. A consent has to be obtained from the faculty of graduate studies for sharing data as data form part of graduate students thesis.
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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.
Zakereyya Albashaireh, PhD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing composite restoration repair by traditional acid etch treatment procedure and adhesive., Composite restoration repair by acid etching, silane solution application, and then adhesive. and Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive. in people with Defective Composite Restorations, run by King Abdullah University Hospital at 1 site in Jordan.
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 6 inclusion and 6 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 6 Mar 2025. 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 Jordan. 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?
Assessment of the quality of the repaired restoration retention, colour match, marginal discoloration, marginal adaptation, anatomical form and surface roughness. (time frame: 2 years). 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 NCT06005571, which also lists 1 linked publication.
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 6 Mar 2025.