Class II Dental CariesNCT04943120
Clinical Evaluation of "Snow-plow"Technique Versus Bulk Fill Technique in Restorations of Class II Cavities
A study testing "Snow-plow" technique and Bulk fill technique in people with Class II Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the performance of " snow-plow" technique as compared to Bulk Fill technique in restoration of class II cavities. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Class II Dental Caries
- What is being tested?
- "Snow-plow" technique and Bulk fill technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2021to 27 Feb 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- class II carious lesions in premolars and molars.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Who cannot join
- Deep carious defects (close to pulp, less than 1 mm distance).
- Periapical pathology or signs of pulpal pathology.
- Endodontically treated teeth
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion or occlusal contacts or history of bruxism.
- Severe periodontal affection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of "Snow-Plow" Technique Versus Bulk Fill Technique in Restoration of Class II Cavities: Randomized Clinical Trial
The aim of the study is to assess the performance of " snow-plow" technique as compared to Bulk Fill technique in restoration of class II cavities.
Read the detailed description
- With limited evidence-based information about the clinical performance of resin composite in class II cavities. it is beneficial to compare the newly introduced "snow-plow' technique using a randomized clinical trial to test the null hypothesis that this new technique has the same clinical performance.
- The comparator will be the bulk fill technique as an alternative to the conventional layering technique. This is because it has shown lower polymerization shrinkage when comparing it to the conventional composite. Bulk fill has reduced the chair time for the patient. It is done by the application of 4mm increment and cured at once.
- Patients are selected according to the eligibility criteria discussed in the following section.
- local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. A standard class II cavity will be prepared at the two-surface cavities.
- The preparation will be performed using rotary instrumentation for cavity preparation by a water-cooled high-speed hand-piece by the same operator.
- The teeth are then restored using one of the two techniques according to their allocation with the same steps discussed in the different arms.
- The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures.
- Conditions
- Class II Dental Caries
- Being tested
- "Snow-plow" technique, Bulk fill technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Snow-plow" techniqueProcedure or surgery
In class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds.
Bulk fill techniqueProcedure or surgery
In class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized.
| Study group | Role | What they receive |
|---|---|---|
| "Snow-Plow" technique | Experimental | In class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds. Receives: Procedure: "Snow-plow" technique |
| Bulk Fill technique | Active comparator | In class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized. Receives: Procedure: Bulk fill technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance
USPHS Criteria
Measured: day 1
clinical performance
USPHS Criteria
Measured: 3 months
clinical performance
USPHS Criteria
Measured: 6 months
clinical performance
USPHS Criteria
Measured: 9 months
clinical performance
USPHS Criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start30 Aug 2021
- Primary completion1 Sep 2022
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Dental 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
- Model description
- 1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohamed Ahmed Gomaa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943120
- Sponsor's protocol ID
- 14422019484260
- Status last verified
- Feb 2024
- First submitted
- 21 Jun 2021
- Last updated
- 6 Feb 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of "Snow-Plow" Technique Versus Bulk Fill Technique in Restoration of Class II Cavities: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04943120
- Acronym / sponsor ID
- 14422019484260
- Conditions
- Class II Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 29 Jun 2021 (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 the study is to assess the performance of " snow-plow" technique as compared to Bulk Fill technique in restoration of class II cavities.
Detailed description
- With limited evidence-based information about the clinical performance of resin composite in class II cavities. it is beneficial to compare the newly introduced "snow-plow' technique using a randomized clinical trial to test the null hypothesis that this new technique has the same clinical performance.
- The comparator will be the bulk fill technique as an alternative to the conventional layering technique. This is because it has shown lower polymerization shrinkage when comparing it to the conventional composite. Bulk fill has reduced the chair time for the patient. It is done by the application of 4mm increment and cured at once.
- Patients are selected according to the eligibility criteria discussed in the following section.
- local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. A standard class II cavity will be prepared at the two-surface cavities.
- The preparation will be performed using rotary instrumentation for cavity preparation by a water-cooled high-speed hand-piece by the same operator.
- The teeth are then restored using one of the two techniques according to their allocation with the same steps discussed in the different arms.
- The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1
| Arm | Type | Receives |
|---|---|---|
| "Snow-Plow" technique | Experimental | Procedure: "Snow-plow" techniqueIn class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds. |
| Bulk Fill technique | Active comparator | Procedure: Bulk fill techniqueIn class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- class II carious lesions in premolars and molars.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Key exclusion criteria (7 listed)
- Deep carious defects (close to pulp, less than 1 mm distance).
- Periapical pathology or signs of pulpal pathology.
- Endodontically treated teeth
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
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 |
|---|---|---|
| "Snow-plow" techniqueIn class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds. | Procedure or surgery | "Snow-Plow" technique |
| Bulk fill techniqueIn class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized. | Procedure or surgery | Bulk Fill technique |
Primary outcome
clinical performance
Time frame: day 1
USPHS Criteria
clinical performance
Time frame: 3 months
USPHS Criteria
clinical performance
Time frame: 6 months
USPHS Criteria
clinical performance
Time frame: 9 months
USPHS Criteria
clinical performance
Time frame: 12 months
USPHS Criteria
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 6 Feb 2024.
- Individual participant dataSharing planned: No
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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 "Snow-plow" technique and Bulk fill technique in people with Class II Dental Caries, 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 3 inclusion and 7 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 6 Feb 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?
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?
clinical performance (time frame: day 1). The study lists 5 primary outcomes in all. 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 6 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.