Contact Tightness in Restoring Proximal Surfaces in Posterior TeethNCT06596707
Contact Tightness of Zirconomer Versus Nanohybrid Composite in Occlusoproximal Cavities in Molars
A study testing Zirconomer and Nanohybrid composite in people with Contact Tightness in Restoring Proximal Surfaces in Posterior Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
To achieve an optimal contact area is essential to avoid tooth migration, food impaction, and the occurrence of secondary caries. However, proximal restorations constitute challenge for the professional and tight contact points are difficult to obtain depending not only on tools used, but also on type of restorative… Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Tightness in Restoring Proximal Surfaces in Posterior Teeth
- What is being tested?
- Zirconomer and Nanohybrid composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2023to 1 Nov 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with occlusoproximal caries in molars classified as ICDAS III or IV.
- 19-35 years.
- Males or Females.
- Co-operative patients approving to participate in the trial.
- Occlusoproximal caries in molars classified as ICDAS III or IV.
- Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
- Intact contact with opposing teeth.
- Teeth with no previous restorations in other surfaces.
Who cannot join
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylate.
- Rampant caries.
- Heavy smoking.
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- Xerostomia.
- Lack of compliance.
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders.
- b- Eligibility Criteria of teeth:
- Extensive carious lesions
- Periapical pathology or signs of pulpal pathology.
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Sever periodontal affection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Proximal Contact Tightness of Zirconia Reinforced Glass Ionomer Versus Conventional Nanohybrid Resin Composite: a Randomized Clinical Trial
To achieve an optimal contact area is essential to avoid tooth migration, food impaction, and the occurrence of secondary caries. However, proximal restorations constitute challenge for the professional and tight contact points are difficult to obtain depending not only on tools used, but also on type of restorative material. Current tooth-colored restorative materials are not condensable and there is shrinkage with setting. The aim of this study is to compare the proximal contact tightness of zirconia reinforced glass ionomer versus conventional nanohybrid resin composite when used in class II cavities.
- Being tested
- Zirconomer, Nanohybrid composite
- Keywords
- Zirconomer, Glass Ionomer, Contact tightness, Occlusoproximal cavities, Resin composite, Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZirconomerProcedure or surgery
zirconia modified glass ionomer
Nanohybrid compositeProcedure or surgery
conventional composite
| Study group | Role | What they receive |
|---|---|---|
| Zirconomer in Class II cavities | Experimental | Zirconia modified glass ionomer restorative material Receives: Procedure: Zirconomer |
| Nanohybrid composite in Class II cavities | Active comparator | Conventionally used aesthetic restorations in class II Receives: Procedure: Nanohybrid composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Tightness
Measuring the adequacy of proximal contact restoration using intervention \' zirconomer\" versus control which is Nanohybrid resin composite.
Heaviness of this contact using Modified USPHS criteria. USPHS criteria are standardized in which a dental floss is used.
Contact tightness can have one of three scores:
Alpha Bravo Charlie
Measured: baseline, 3 months, 6 months, 9 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Jul 2023
- Primary completion12 Sep 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Tightness in Restoring Proximal Surfaces in Posterior TeethStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Fathi Abdelsalam, Cairo University
- Investigators
- Alaa F Abdelsalam, phD, Principal investigator, lecturer of conservative dentistry, Cairo universityHadier M Gad, PhD, Principal investigator, Lecturer of conservative dentistry, Cairo universityManar A Elmokanen, PhD, Principal investigator, Lecturer of conservative dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596707
- Sponsor's protocol ID
- 2255884
- Status last verified
- Sep 2024
- First submitted
- 25 Aug 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Proximal Contact Tightness of Zirconia Reinforced Glass Ionomer Versus Conventional Nanohybrid Resin Composite: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06596707
- Acronym / sponsor ID
- 2255884
- Keywords
- Zirconomer, Glass Ionomer, Contact tightness, Occlusoproximal cavities, Resin composite, Class II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 12 Sep 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 19 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.
To achieve an optimal contact area is essential to avoid tooth migration, food impaction, and the occurrence of secondary caries. However, proximal restorations constitute challenge for the professional and tight contact points are difficult to obtain depending not only on tools used, but also on type of restorative material. Current tooth-colored restorative materials are not condensable and there is shrinkage with setting. The aim of this study is to compare the proximal contact tightness of zirconia reinforced glass ionomer versus conventional nanohybrid resin composite when used in class II cavities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zirconomer in Class II cavities | Experimental | Procedure: ZirconomerZirconia modified glass ionomer restorative material |
| Nanohybrid composite in Class II cavities | Active comparator | Procedure: Nanohybrid compositeConventionally used aesthetic restorations in class II |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with occlusoproximal caries in molars classified as ICDAS III or IV.
- 19-35 years.
- Males or Females.
- Co-operative patients approving to participate in the trial.
- Occlusoproximal caries in molars classified as ICDAS III or IV.
Key exclusion criteria (16 listed)
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- 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 |
|---|---|---|
| Zirconomerzirconia modified glass ionomer | Procedure or surgery | Zirconomer in Class II cavities |
| Nanohybrid compositeconventional composite | Procedure or surgery | Nanohybrid composite in Class II cavities |
Primary outcome
Contact Tightness
Time frame: baseline, 3 months, 6 months, 9 months and 1 year
Measuring the adequacy of proximal contact restoration using intervention \' zirconomer\" versus control which is Nanohybrid resin composite. Heaviness of this contact using Modified USPHS criteria. USPHS criteria are standardized in which a dental floss is used. Contact tightness can have one of three scores: Alpha Bravo Charlie
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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.
Alaa F Abdelsalam, phD principal investigator
lecturer of conservative dentistry, Cairo university
Hadier M Gad, PhD principal investigator
Lecturer of conservative dentistry, Cairo university
Manar A Elmokanen, PhD principal investigator
Lecturer of conservative dentistry, Cairo 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 Zirconomer and Nanohybrid composite in people with Contact Tightness in Restoring Proximal Surfaces in Posterior Teeth, 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 8 inclusion and 16 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 19 Sep 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?
Results are not available in the source record.
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?
Contact Tightness (time frame: baseline, 3 months, 6 months, 9 months and 1 year). 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 19 Sep 2024.