Posterior Complex Carious Proximal CavitiesNCT05625243
Evaluation of the Proximal Contact Quality in Posterior Complex Carious Cavities Restored With Bulk Fill Ormocer and Resin Composite Using a Precontoured Circumferential Matrix System Versus Pre Contoured Sectional Matrix System
A study testing Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA), Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia) and Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA) in people with Posterior Complex Carious Proximal Cavities, run by Cairo University at 1 site in Egypt.
Trial summary
The use of ormocers with precontoured circumferential matrix system allow predictable restoration of complex proximal posterior cavities with less time and fewer tools required to produce optimum proximal contact size, location and magnitude and restoration durability with higher wear resistance. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Complex Carious Proximal Cavities
- What is being tested?
- Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA), Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia) and Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2022to Dec 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Posterior complex proximal carious lesions Vital upper or lower posterior teeth with no signs of irreversible pulpitis. Presence of adjacent and opposing teeth with normal occlusion
Who cannot join
- Proximal carious cavities in the mesial surface of first premolars. Periapical pathology or signs of pulpal pathology. Possible prosthodontic restoration of teeth. Heavy occlusion and occlusal contacts or history of bruxism. Pulpitis, non-vital or endodontically treated teeth. Sever periodontal affection
Trial locations and contacts
1 site in 1 country.
fatheya el shinawy, master contact
Egypt1 site
Faculty of Dentistry, Cairo University,
Cairo
Faculty of Dentistry, Cairo University,
About this study
Official title: Evaluation of the Proximal Contact Quality in Posterior Complex Carious Cavities Restored With Bulk Fill Ormocer and Resin Composite Using a Precontoured Circumferential Matrix System Versus Precontoured Sectional Matrix System
The use of ormocers with precontoured circumferential matrix system allow predictable restoration of complex proximal posterior cavities with less time and fewer tools required to produce optimum proximal contact size, location and magnitude and restoration durability with higher wear resistance.
Read the detailed description
After profound local anesthesia, conservative cavity preparations will be performed with high-speed burs (no.:330, Meisinger, Germany) under constant refrigeration. Intermittent rotary instrument contact with tooth limited to the removal of compromised enamel. The cavity outline is restricted to the removal of carious tissue with spherical carbide burs at low speed. In the removal of defective restorations, the friable enamel and remnant carious tissue will be removed in the same way. All teeth will be restored using a rubber dam. The universal bonding agent (Voco, Cuxhaven, Germany) will be applied with previous selective enamel etching with 37% phosphoric acid for 30 seconds. These materials will be inserted following the manufacturer's instructions.
After cavity preparation, each participant will choose a random number from an opaque sealed envelope, then patient will select from random numbers prepared by Y.H. to randomly assign interventions to the participant oral cavity.
All restorations will be prepared, restored, finished and polished by one operator.
- Being tested
- Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA), Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia), Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)Other
A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.
Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)Other
A suitable size precontoured sectional matrix band (Saddle matrix, TORVM, Moscow, Russia) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges, TORVM, Moscow, Russia) and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.
Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)Other
A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.
| Study group | Role | What they receive |
|---|---|---|
| Bulk-fill ormocer with Precontoured circumferential matrix system | Experimental | A suitable size precontoured circumferential matrix band will be selected and placed. Teeth separation will be acquired with a suitable size wedge and a separation ring . Then the bulk-fill ormocer will be applied and light cured according to the manufacturer instructions. Receives: Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA); Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia); Other: Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA) |
| Bulk-fill ormocer with Precontoured Saddle matrix system | Experimental | Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges and a separation ring Then the bulk-fill ormocer will be applied and light cured according to the manufacturer instructions. Receives: Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA); Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia); Other: Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA) |
| X-tra fill, Voco) with Precontoured circumferential matrix (Palodent 360, Dentsply ) | Experimental | .Bulk-fill resin composite (X-tra fill, Voco) with Precontoured circumferential matrix system (Palodent 360) will be applied Receives: Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA); Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia); Other: Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA) |
| Bulk-fill resin composite with Precontoured sectional matrix systym | Active comparator | Teeth separation will be acquired with a wooden wedge and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk fill resin composite will be applied and light cured according to the manufacturer instructions. Receives: Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA); Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia); Other: Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Contact quality
50 micro sectional matrix band (Saddle matrix, TORVM, Moscow, Russia)
FDI criteria (Hickel et al., 2010)
Measured: one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start26 Nov 2022 (estimated)
- Primary completion6 Nov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Complex Carious Proximal CavitiesStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abd Alghaffar Khafagi, Cairo University
- Investigators
- Ahmed Alghaffar khafagi, master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625243
- Sponsor's protocol ID
- 14422018454217
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2022
- Last updated
- 22 Nov 2022
- 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 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Proximal Contact Quality in Posterior Complex Carious Cavities Restored With Bulk Fill Ormocer and Resin Composite Using a Precontoured Circumferential Matrix System Versus Precontoured Sectional Matrix System
- ClinicalTrials.gov ID
- NCT05625243
- Acronym / sponsor ID
- 14422018454217
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Nov 2022 (estimated)
- Primary completion
- 6 Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Nov 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.
The use of ormocers with precontoured circumferential matrix system allow predictable restoration of complex proximal posterior cavities with less time and fewer tools required to produce optimum proximal contact size, location and magnitude and restoration durability with higher wear resistance.
Detailed description
After profound local anesthesia, conservative cavity preparations will be performed with high-speed burs (no.:330, Meisinger, Germany) under constant refrigeration. Intermittent rotary instrument contact with tooth limited to the removal of compromised enamel. The cavity outline is restricted to the removal of carious tissue with spherical carbide burs at low speed. In the removal of defective restorations, the friable enamel and remnant carious tissue will be removed in the same way. All teeth will be restored using a rubber dam. The universal bonding agent (Voco, Cuxhaven, Germany) will be applied with previous selective enamel etching with 37% phosphoric acid for 30 seconds. These materials will be inserted following the manufacturer's instructions.
After cavity preparation, each participant will choose a random number from an opaque sealed envelope, then patient will select from random numbers prepared by Y.H. to randomly assign interventions to the participant oral cavity.
All restorations will be prepared, restored, finished and polished by one operator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bulk-fill ormocer with Precontoured circumferential matrix system | Experimental | Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA), Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia), Other: Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)A suitable size precontoured circumferential matrix band will be selected and placed. Teeth separation will be acquired with a suitable size wedge and a separation ring . Then the bulk-fill ormocer will be applied and light cured according to the manufacturer instructions. |
| Bulk-fill ormocer with Precontoured Saddle matrix system | Experimental | Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA), Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia), Other: Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges and a separation ring Then the bulk-fill ormocer will be applied and light cured according to the manufacturer instructions. |
| X-tra fill, Voco) with Precontoured circumferential matrix (Palodent 360, Dentsply ) | Experimental | Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA), Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia), Other: Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA).Bulk-fill resin composite (X-tra fill, Voco) with Precontoured circumferential matrix system (Palodent 360) will be applied |
| Bulk-fill resin composite with Precontoured sectional matrix systym | Active comparator | Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA), Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia), Other: Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)Teeth separation will be acquired with a wooden wedge and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk fill resin composite will be applied and light cured according to the manufacturer instructions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Posterior complex proximal carious lesions Vital upper or lower posterior teeth with no signs of irreversible pulpitis. Presence of adjacent and opposing teeth with normal occlusion
Key exclusion criteria (1 listed)
- Proximal carious cavities in the mesial surface of first premolars. Periapical pathology or signs of pulpal pathology. Possible prosthodontic restoration of teeth. Heavy occlusion and occlusal contacts or history of bruxism. Pulpitis, non-vital or endodontically treated teeth. Sever periodontal affection
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 |
|---|---|---|
| Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions. | Other | Bulk-fill ormocer with Precontoured Saddle matrix system, Bulk-fill ormocer with Precontoured circumferential matrix system, Bulk-fill resin composite with Precontoured sectional matrix systym, X-tra fill, Voco) with Precontoured circumferential matrix (Palodent 360, Dentsply ) |
| Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)A suitable size precontoured sectional matrix band (Saddle matrix, TORVM, Moscow, Russia) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges, TORVM, Moscow, Russia) and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions. | Other | Bulk-fill ormocer with Precontoured Saddle matrix system, Bulk-fill ormocer with Precontoured circumferential matrix system, Bulk-fill resin composite with Precontoured sectional matrix systym, X-tra fill, Voco) with Precontoured circumferential matrix (Palodent 360, Dentsply ) |
| Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions. | Other | Bulk-fill ormocer with Precontoured Saddle matrix system, Bulk-fill ormocer with Precontoured circumferential matrix system, Bulk-fill resin composite with Precontoured sectional matrix systym, X-tra fill, Voco) with Precontoured circumferential matrix (Palodent 360, Dentsply ) |
Primary outcome
Proximal Contact quality
Time frame: one year follow up
50 micro sectional matrix band (Saddle matrix, TORVM, Moscow, Russia) FDI criteria (Hickel et al., 2010)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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.
fatheya el shinawy, master contact
Ahmed Alghaffar khafagi, master principal investigator
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 Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA), Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia) and Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA) in people with Posterior Complex Carious Proximal Cavities, 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 1 inclusion and 1 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 22 Nov 2022. 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?
Contact Ahmed Alghaffar khafagi, master (01016997764, ahmed.khafagi@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 quality (time frame: one year follow up). 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 22 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.