Proximal ContactNCT03795727
Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact
A study testing MD ring and precontoured sectional matrix by TOR VM and Circumferential matrix and tofflemire retainer by Kerr in people with Proximal Contact, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effects of different matricing techniques either sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and contours during restoration of class II cavities with resin composite by undergraduate students or postgraduate dentists. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Proximal Contact
- What is being tested?
- MD ring and precontoured sectional matrix by TOR VM and Circumferential matrix and tofflemire retainer by Kerr
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2020to 12 Mar 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Compound class II cavities
- Good oral hygiene
- No spacing or crowding
- Healthy peridontium
Who cannot join
- Complex class II cavities
- Poor oral hygiene
- Spacing or crowding
- Evidence of peridontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact by Undergraduate Students and Postgraduate Dentists: Randomized Controlled Trial
The aim of this study is to evaluate the effects of different matricing techniques either sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and contours during restoration of class II cavities with resin composite by undergraduate students or postgraduate dentists.
- Conditions
- Proximal Contact
- Being tested
- MD ring and precontoured sectional matrix by TOR VM, Circumferential matrix and tofflemire retainer by Kerr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD ring and precontoured sectional matrix by TOR VMDevice
MD ring (separation ring) and precontoured sectional matrix (thickness 0.035mm hard) and a wedge was used to secure matrix in place
Circumferential matrix and tofflemire retainer by KerrDevice
Circumferential matrix (thickness 0.038mm) applied by tofflemire retainer and secured in place with wedge
| Study group | Role | What they receive |
|---|---|---|
| Sectional matrix | Experimental | precontoured sectional matrix band Receives: Device: MD ring and precontoured sectional matrix by TOR VM |
| Circumferential matrix | Active comparator | Circumferential matrix band applied by tofflemire retainer Receives: Device: Circumferential matrix and tofflemire retainer by Kerr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal contact
Reproduction of proximal contact either optimum, tight or loose (Categorical)
Measured: Up to 3 hours from randomization till contact is restored
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start20 Jan 2020
- Primary completion12 Feb 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal ContactStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Osama Shaalan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795727
- Sponsor's protocol ID
- circumferential vs sectional
- Status last verified
- Apr 2020
- First submitted
- 3 Jan 2019
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact by Undergraduate Students and Postgraduate Dentists: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03795727
- Acronym / sponsor ID
- circumferential vs sectional
- Conditions
- Proximal Contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 8 Jan 2019 (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 effects of different matricing techniques either sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and contours during restoration of class II cavities with resin composite by undergraduate students or postgraduate dentists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sectional matrix | Experimental | Device: MD ring and precontoured sectional matrix by TOR VMprecontoured sectional matrix band |
| Circumferential matrix | Active comparator | Device: Circumferential matrix and tofflemire retainer by KerrCircumferential matrix band applied by tofflemire retainer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Compound class II cavities
- Good oral hygiene
- No spacing or crowding
- Healthy peridontium
Key exclusion criteria (4 listed)
- Complex class II cavities
- Poor oral hygiene
- Spacing or crowding
- Evidence of peridontal disease
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 |
|---|---|---|
| MD ring and precontoured sectional matrix by TOR VMMD ring (separation ring) and precontoured sectional matrix (thickness 0.035mm hard) and a wedge was used to secure matrix in place | Device | Sectional matrix |
| Circumferential matrix and tofflemire retainer by KerrCircumferential matrix (thickness 0.038mm) applied by tofflemire retainer and secured in place with wedge | Device | Circumferential matrix |
Primary outcome
Proximal contact
Time frame: Up to 3 hours from randomization till contact is restored
Reproduction of proximal contact either optimum, tight or loose (Categorical)
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 21 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Proximal Contact
Not yet recruiting
Ni-Ti Shape-Memory Versus Conventional Sectional Matrices Systems in Class II Composite Restorations: A Randomized Clinical Trial
Class II Composite Restorations
Not yet recruiting
Proximal Contact Tightness of Zirconia Crowns: Digital Intraoral Scanning vs Conventional Impressions
Proximal Contacts, Zirconia Crowns
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD ring and precontoured sectional matrix by TOR VM and Circumferential matrix and tofflemire retainer by Kerr in people with Proximal Contact, 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 4 inclusion and 4 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 21 Apr 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 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?
Proximal contact (time frame: Up to 3 hours from randomization till contact is restored). 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 21 Apr 2020.