Proximal CariesNCT06606379
Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii
A study testing I1 (Intervention), I2 (Intervention) and I3 (Intervention) in people with Proximal Caries, run by Cairo University.
Trial summary
The aim of this study is to evaluate the interdental separation of various separation systems and their impact on the proximal contact tightness and contour in compound class II nanohybrid resin composite restorations. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Proximal Caries
- What is being tested?
- I1 (Intervention), I2 (Intervention) and I3 (Intervention)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2026
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with posterior compound proximal carious cavities in molars.
- Age of (25-40) years.
- Molars with compound proximal carious cavities score 4 or 5 ICDS.
- Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
- Presence of adjacent and opposing teeth with normal occlusion
Who cannot join
- Patients with major systemic disorders or xerostomia.
- Patients with periodontal disease.
- Patients with para-functional habits.
- Presence of malocclusion or signs of pathological teeth wear
- Non vital teeth or teeth with signs of pulpal pathology.
- Teeth mobility or clinical attachment loss.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii Nanohybrid Resin Composite Restorations: Randomized Clinical Trial
The aim of this study is to evaluate the interdental separation of various separation systems and their impact on the proximal contact tightness and contour in compound class II nanohybrid resin composite restorations.
Read the detailed description
The target population consists of adult patients aged 25-40, with posterior compound proximal carious cavities (ICDS score 4 or 5) in molars. The interventions under investigation include three different separation systems: the Resin ring (DR-Resin ring, Egypt), Elliot separator (Pfingst \& Co, USA), and Stainless Steel Metal ring (TOR VM ring, Russia). These systems will be compared to a Nickel titanium 3D-fusion ring (Garrison, USA). The primary outcomes assessed are proximal contact tightness and form/contour, measured visually according to FDI criteria, with scoring systems adapted from Hickel et al. (2023). Secondary outcomes, such as patient comfort (measured by a pain rating scale), and the emergence profile (assessed via bitewing radiographs), will also be considered. Data will be collected immediately postoperatively (T0), at 30 days (T1), and after 6 months (T2). The study will be conducted as a randomized clinical trial. The null hypothesis suggests that there will be no significant differences in proximal contact tightness or contour across the different separation systems used.
- Conditions
- Proximal Caries
- Being tested
- I1 (Intervention), I2 (Intervention), I3 (Intervention), C (comparator)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I1 (Intervention)Device
Resin ring (DR- Resin ring, Egypt)
I2 (Intervention)Device
Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA)
I3 (Intervention)Device
Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)
C (comparator)Device
Nickel titanium 3D-fusion ring (Garrison, USA)
| Study group | Role | What they receive |
|---|---|---|
| C (comparator) | Active comparator | Nickel titanium 3D-fusion ring (Garrison, USA) Receives: Device: C (comparator) |
| I1 (Intervention) | Experimental | Resin ring (DR- Resin ring, Egypt) Receives: Device: I1 (Intervention) |
| I2 (Intervention) | Experimental | Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA) Receives: Device: I2 (Intervention) |
| I3 (Intervention) | Experimental | Stainless Steel Metal ring (TOR VM ring, Moscow, Russia) Receives: Device: I3 (Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Contact tightness (Success rate)
Visual examination and 25-/50-/100-µm blade according to FDI Criteria
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (3)
Form and Contour
Visual examination according to FDI Criteria
Measured: From enrollment to the end of treatment at 6 months
Patient Comfort
Pain rating scale
Measured: From enrollment to the end of treatment at 6 months
Emergence profile
Bitewing Radiographs
Measured: From enrollment to the end of treatment 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 posted23 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal CariesStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Hesham Mohamed, Cairo University
- Investigators
- Hadeer H Mohamed, MSC. degree, Principal investigator, Assistant Lecturer of Conservative Dentistry, Faculty of Dentistry Cairo University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606379
- Sponsor's protocol ID
- IMPACT OF SEPARATION METHODS
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii Nanohybrid Resin Composite Restorations: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06606379
- Acronym / sponsor ID
- IMPACT OF SEPARATION METHODS
- Conditions
- Proximal Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 23 Sep 2024 (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.
The aim of this study is to evaluate the interdental separation of various separation systems and their impact on the proximal contact tightness and contour in compound class II nanohybrid resin composite restorations.
Detailed description
The target population consists of adult patients aged 25-40, with posterior compound proximal carious cavities (ICDS score 4 or 5) in molars. The interventions under investigation include three different separation systems: the Resin ring (DR-Resin ring, Egypt), Elliot separator (Pfingst \& Co, USA), and Stainless Steel Metal ring (TOR VM ring, Russia). These systems will be compared to a Nickel titanium 3D-fusion ring (Garrison, USA). The primary outcomes assessed are proximal contact tightness and form/contour, measured visually according to FDI criteria, with scoring systems adapted from Hickel et al. (2023). Secondary outcomes, such as patient comfort (measured by a pain rating scale), and the emergence profile (assessed via bitewing radiographs), will also be considered. Data will be collected immediately postoperatively (T0), at 30 days (T1), and after 6 months (T2). The study will be conducted as a randomized clinical trial. The null hypothesis suggests that there will be no significant differences in proximal contact tightness or contour across the different separation systems used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C (comparator) | Active comparator | Device: C (comparator)Nickel titanium 3D-fusion ring (Garrison, USA) |
| I1 (Intervention) | Experimental | Device: I1 (Intervention)Resin ring (DR- Resin ring, Egypt) |
| I2 (Intervention) | Experimental | Device: I2 (Intervention)Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA) |
| I3 (Intervention) | Experimental | Device: I3 (Intervention)Stainless Steel Metal ring (TOR VM ring, Moscow, Russia) |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals with posterior compound proximal carious cavities in molars.
- Age of (25-40) years.
- Molars with compound proximal carious cavities score 4 or 5 ICDS.
- Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
- Presence of adjacent and opposing teeth with normal occlusion
Key exclusion criteria (6 listed)
- Patients with major systemic disorders or xerostomia.
- Patients with periodontal disease.
- Patients with para-functional habits.
- Presence of malocclusion or signs of pathological teeth wear
- Non vital teeth or teeth with signs of pulpal pathology.
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 |
|---|---|---|
| I1 (Intervention)Resin ring (DR- Resin ring, Egypt) | Device | I1 (Intervention) |
| I2 (Intervention)Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA) | Device | I2 (Intervention) |
| I3 (Intervention)Stainless Steel Metal ring (TOR VM ring, Moscow, Russia) | Device | I3 (Intervention) |
| C (comparator)Nickel titanium 3D-fusion ring (Garrison, USA) | Device | C (comparator) |
Primary outcome
Proximal Contact tightness (Success rate)
Time frame: From enrollment to the end of treatment at 6 months
Visual examination and 25-/50-/100-µm blade according to FDI Criteria
3 secondary outcomes
Form and Contour
Time frame: From enrollment to the end of treatment at 6 months
Patient Comfort
Time frame: From enrollment to the end of treatment at 6 months
Emergence profile
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Hadeer H Mohamed, MSC. degree principal investigator
Assistant Lecturer of Conservative Dentistry, Faculty of Dentistry Cairo University, Egypt.
Questions about this trial
What is this clinical trial studying?
A study testing I1 (Intervention), I2 (Intervention) and I3 (Intervention) in people with Proximal Caries, run by Cairo University.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadeer H Mohamed, MSC. degree (+20 1015779373, hadeer.hesham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal Contact tightness (Success rate) (time frame: From enrollment to the end of treatment at 6 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 23 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.