Tooth DecayNCT05749640
The Proximal Contact Tightness and Location in Class II Composite Restorations
A study testing Precontoured sectional matrix EZ COAT, PerForm™ and AdDent Trimax™ in people with Tooth Decay, run by karim mohamed at 1 site in Egypt.
Trial summary
This study aims to investigate consecutive biological changes in proximal contact tightness using digital force gauge and evaluate proximal contact location using cone beam computed tomography between class II direct composite restorations and adjacent teeth after using sectional matrix system and with different… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tooth Decay
- What is being tested?
- Precontoured sectional matrix EZ COAT, PerForm™ and AdDent Trimax™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 24 May 2022to 30 May 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of proximal caries in CBCT x-ray with score 3 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).
- Presence of the antagonist and the adjacent tooth making contact.
- The teeth to be restored had to show no signs of pulpitis but positive sensitivity using endo ice testing.
- Size of the isthmus with no more than 2/3 of the intercuspal distance
- Good oral health and absence of periodontal disease
- Patients who are not suffering from severe systemic diseases or allergies
Who cannot join
- Medically compromised patients
- Clinical signs of bruxism, traumatic malocclusion
- Pregnant or breast feeding at the time of restoration placement
- Intolerance or allergy toward the applied restorative materials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Proximal Contact Tightness and Location in Class II Composite Restoration Using Different Contact Forming Instruments
This study aims to investigate consecutive biological changes in proximal contact tightness using digital force gauge and evaluate proximal contact location using cone beam computed tomography between class II direct composite restorations and adjacent teeth after using sectional matrix system and with different contact forming instruments.
- Conditions
- Tooth Decay
- Being tested
- Precontoured sectional matrix EZ COAT, PerForm™, AdDent Trimax™, Contact Pro™
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precontoured sectional matrix EZ COATOther
All teeth will be treated with (Palodent ® plus sectional matrix system) (sectional matrix, biting ring, plastic diamond wedge)
PerForm™Other
Treated with (PerForm™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
AdDent Trimax™Other
Treated with (AdDent Trimax™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Contact Pro™Other
Treated with (Contact Pro™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
| Study group | Role | What they receive |
|---|---|---|
| Palodent® plus sectional matrix system "Control group" | Active comparator | Not described Receives: Other: Precontoured sectional matrix EZ COAT |
| PerForm™ "Experimental" | Experimental | Not described Receives: Other: PerForm™ |
| Trimax™ "Experimental" | Experimental | Not described Receives: Other: AdDent Trimax™ |
| Contact Pro™ "Experimental" | Experimental | Not described Receives: Other: Contact Pro™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proximal contact tightness
Proximal contact tightness (PCT) will be measured using the custom-made contact pressure system that was based on the tooth pressure meter, a device fabricated at the University of Technology, Delft, the Netherlands. (20) The system will use a 0.05-mm-thick metal strip inserted interdentally from An occlusal direction . The metal strip will be connected to the digital force gauge (Mark-10 series 2 digital force gauge). The tightness of the proximal contact will be quantified as the maximum frictional force when the strip will slowly removed in a buccal-lingual direction. The maximum force will be recorded on the screen of the gauge for each measurement when the gauge will be switched to peak-mode
Measured: baseline, immediately postoperative, 1 month, 3 month, 9 month, and 12 month
Secondary outcomes (1)
Change in proximal contact location
calibration will be carried out by a radiologist, who evaluates the teeth carefully scrolling down through the images from the floor of the pulp chamber in all three orthogonal reconstructions (axial, coronal, and sagittal). To ensure image standardization, all cone-beam computed tomography (CBCT) images will be chosen from a single machine with a standard field of view, voxel size, exposure time and the thickness of the slice.
CBCT images will be analyzed with the built-in digital imaging software. The measurement tool will be used to determine the total length of the crown of the restored teeth, measured from the tip of the mesiobuccal cusp to the cementoenamel junction. Based on this length, the crown portion will be divided into three levels: coronal, middle and apical thirds.
Measured: baseline and immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start24 May 2022
- Primary completion30 May 2023
- Study completion30 May 2023
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 Tooth DecayStudies 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
- This study will be a randomized control clinical trial in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- karim mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, karim mohamed, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749640
- Sponsor's protocol ID
- AlexandriaU 0425-04/2022
- Status last verified
- Jun 2023
- First submitted
- 24 Oct 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Abbassy KM, Elmahy WA, Holiel AA. Evaluation of the proximal contact tightness in class II resin composite restorations using different contact forming instruments: a 1-year randomized controlled clinical trial. BMC Oral Health. 2023 Oct 7;23(1):729. doi: 10.1186/s12903-023-03462-5.
PubMed 37805456
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Proximal Contact Tightness and Location in Class II Composite Restoration Using Different Contact Forming Instruments
- ClinicalTrials.gov ID
- NCT05749640
- Acronym / sponsor ID
- AlexandriaU 0425-04/2022
- Conditions
- Tooth Decay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- karim mohamedUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 1 Mar 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.
This study aims to investigate consecutive biological changes in proximal contact tightness using digital force gauge and evaluate proximal contact location using cone beam computed tomography between class II direct composite restorations and adjacent teeth after using sectional matrix system and with different contact forming instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This study will be a randomized control clinical trial in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines
| Arm | Type | Receives |
|---|---|---|
| Palodent® plus sectional matrix system "Control group" | Active comparator | Other: Precontoured sectional matrix EZ COAT |
| PerForm™ "Experimental" | Experimental | Other: PerForm™ |
| Trimax™ "Experimental" | Experimental | Other: AdDent Trimax™ |
| Contact Pro™ "Experimental" | Experimental | Other: Contact Pro™ |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Presence of proximal caries in CBCT x-ray with score 3 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).
- Presence of the antagonist and the adjacent tooth making contact.
- The teeth to be restored had to show no signs of pulpitis but positive sensitivity using endo ice testing.
- Size of the isthmus with no more than 2/3 of the intercuspal distance
- Good oral health and absence of periodontal disease
Key exclusion criteria (4 listed)
- Medically compromised patients
- Clinical signs of bruxism, traumatic malocclusion
- Pregnant or breast feeding at the time of restoration placement
- Intolerance or allergy toward the applied restorative materials
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 |
|---|---|---|
| Precontoured sectional matrix EZ COATAll teeth will be treated with (Palodent ® plus sectional matrix system) (sectional matrix, biting ring, plastic diamond wedge) | Other | Palodent® plus sectional matrix system "Control group" |
| PerForm™Treated with (PerForm™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system) | Other | PerForm™ "Experimental" |
| AdDent Trimax™Treated with (AdDent Trimax™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system) | Other | Trimax™ "Experimental" |
| Contact Pro™Treated with (Contact Pro™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system) | Other | Contact Pro™ "Experimental" |
Primary outcome
Change in proximal contact tightness
Time frame: baseline, immediately postoperative, 1 month, 3 month, 9 month, and 12 month
Proximal contact tightness (PCT) will be measured using the custom-made contact pressure system that was based on the tooth pressure meter, a device fabricated at the University of Technology, Delft, the Netherlands. (20) The system will use a 0.05-mm-thick metal strip inserted interdentally from An occlusal direction . The metal strip will be connected to the digital force gauge (Mark-10 series 2 digital force gauge). The tightness of the proximal contact will be quantified as the maximum frictional force when the strip will slowly removed in a buccal-lingual direction. The maximum force will be recorded on the screen of the gauge for each measurement when the gauge will be switched to peak-mode
1 secondary outcome
Change in proximal contact location
Time frame: baseline and immediately postoperative
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 15 Jun 2023.
- Derived from this study: PubMed 37805456Abbassy KM, Elmahy WA, Holiel AA. Evaluation of the proximal contact tightness in class II resin composite restorations using different contact forming instruments: a 1-year randomized controlled clinical trial. BMC Oral Health. 2023 Oct 7;23(1):729. doi: 10.1186/s12903-023-03462-5.
- Individual participant dataSharing planned: Yes
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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.
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 Precontoured sectional matrix EZ COAT, PerForm™ and AdDent Trimax™ in people with Tooth Decay, run by karim mohamed 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 6 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 15 Jun 2023. 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?
Change in proximal contact tightness (time frame: baseline, immediately postoperative, 1 month, 3 month, 9 month, and 12 month). 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 NCT05749640, 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 15 Jun 2023.