Caries Class IiRCTNCT07033650
Evaluation of Clinical Performance of Bulk Fill Resin Composite Restorations Using Snow Plow Versus Oscillating Packing Technique
A study testing Bulk-fill composite (X-tra Fil), flowable Bulk-fill composite (X-tra Base) and compothixo oscillating packing in people with Caries Class Ii, run by Suez Canal University at 1 site in Egypt.
Trial summary
This is a randomized, controlled, double-blinded clinical trial (the patient and the examiners are blind to the group assignment). Eligible patients will be examined clinically and radiographically using bite-wing radiography, and recruited according to the previously mentioned inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Caries Class Ii
- What is being tested?
- Bulk-fill composite (X-tra Fil), flowable Bulk-fill composite (X-tra Base) and compothixo oscillating packing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2024to 21 Mar 2025
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Each patient should have at least three occluso-proximal carious lesions in the posterior molars in three different quadrants (two upper and one lower)
- Only co-operative patients approving to participate in the trial.
Who cannot join
- Patients with disabilities or severe medically compromised.
- Patients with severe bruxism, clenching or temporomandibular joint disorders.
- Patients with allergy to any components of the materials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Performance of Bulk Fill Resin Composite Restorations Using Snow Plow Versus Oscillating Packing Technique: Randomized Controlled Clinical Trial
This is a randomized, controlled, double-blinded clinical trial (the patient and the examiners are blind to the group assignment). Eligible patients will be examined clinically and radiographically using bite-wing radiography, and recruited according to the previously mentioned inclusion and exclusion criteria. All participants will sign written informed consents after being completely aware of the aim, settings, procedures, benefits and potential side effects of the study. Each tooth will be assigned by a number; R1 (Bulk fill RC), R2 (Snow plow tech) and R3 (Oscillating tech). Restoration numbers will be concealed in an opaque sealed envelope that will be held by a facilitator who will not involve in any of the phases of the clinical trial. Every patient will choose an envelope for each tooth. Patients and examiners will be blinded to the material assignment; the operator also will be blinded for the type of restoration during tooth preparation and will be informed only at the time of restoration placement.
Each case will be evaluated according to FDI criteria, based on both functional (Fracture of material and retention, Marginal adaptation, Occlusal contour and wear, Proximal contact point and food impaction, and Radiographic examination) and biological (Postoperative sensitivity, Recurrence of caries and Tooth integrity) properties. Bitewing radiographs and intra-oral photographs will be also used for assessment of all restorations.
Read more
Assessment of postoperative sensitivity and tooth vitality will be carried out on the patient by application of a cold stimulus (e.g. a blast of cold air). Postoperative sensitivity will be recorded at the time of restoration placement, and throughout all follow-up appointments, and include type of pain, discomfort and duration, and/or on stimulus at clinical assessment and should always be compared with the response of adjacent vital teeth. Intensity will be assessed also with a visual analogue scale (VAS) which is a commonly used tool for measuring pain.
On a scale of 1 to 5, restorations will be rated as follows; score 1: clinically excellent/very good, 2: clinically good, 3: clinically satisfactory, 4: clinically unsatisfactory but repairable and 5: clinically poor/irrepairable and in need of replacement. So the scores 1, 2 and 3 considered clinically successful while scores 4 and 5 considered clinically not successful.
Read the detailed description
This is a randomized, controlled, double-blinded clinical trial (the patient and the examiners are blind to the group assignment). The approval of Ethical committee of the Faculty of Dentistry, Suez Canal University, will be taken. This study will be carried on apparently healthy patients of age group 21-50 years, with at least three occluso-proximal cavitated dentinal lesion on the posterior molars, the patients who will agree to participate in this study will sign an informed consent. Also it will be reported according to the protocol established by CONSORT guidelines to ensure transparent and complete reporting.
Patients will be recruited from outpatient clinic of Operative Dentistry Department in Faculty of Dentistry, Suez Canal University. Eligible patients will be examined clinically and radiographically using bite-wing radiography, and recruited according to the previously mentioned inclusion and exclusion criteria. All participants will sign written informed consents after being completely aware of the aim, settings, procedures, benefits and potential side effects of the study. The data from the study and consent forms will be written in Arabic so that every patient could understand them. Patients will be only admitted to the study after signing the informed consent.
Simple randomization will be assigned for 29 participants. Every patient will be diagnosed by examiners for three posterior class II carious lesions. Each tooth will be assigned by a number; R1 (Bulk fill RC), R2 (Snow plow tech) and R3 (Oscillating tech). Restoration numbers will be concealed in an opaque sealed envelope that will be held by a facilitator who will not involve in any of the phases of the clinical trial. Every patient will choose an envelope for each tooth. Patients and examiners will be blinded to the material assignment; the operator also will be blinded for the type of restoration during tooth preparation and will be informed only at the time of restoration placement.
Each case will be evaluated according to FDI criteria, based on both functional (Fracture of material and retention, Marginal adaptation, Occlusal contour and wear, Proximal contact point and food impaction, and Radiographic examination) and biological (Postoperative sensitivity, Recurrence of caries and Tooth integrity) properties. Assessment of restorations will be performed clinically by visual inspection using magnification loupes (4.5x; Carl Zeiss GmbH, Jena, Germany), dental mirrors, a light source and FDI recommended probes with different tip diameters of 150 and 250 micrometer diameter (150x and 250x, Deppeler, Switzerland) . These probes will be used specially for evaluation of both marginal adaptation (functional property) and tooth integrity of enamel cracks and tooth fractures (biological property). Bitewing radiographs and intra-oral photographs will be also used for assessment of all restorations.
Assessment of postoperative sensitivity and tooth vitality will be carried out on the patient by application of a cold stimulus (e.g. a blast of cold air). Postoperative sensitivity will be recorded at the time of restoration placement, and throughout all follow-up appointments, and include type of pain, discomfort and duration, and/or on stimulus at clinical assessment and should always be compared with the response of adjacent vital teeth. Transient pain brought on by stimulation will be acceptable, while persistent pain renders the restoration unacceptable and necessitates intervention to resolve the problem. Intensity will be assessed also with a visual analogue scale (VAS) which is a commonly used tool for measuring pain.
On a scale of 1 to 5, restorations will be rated as follows; score 1: clinically excellent/very good, 2: clinically good, 3: clinically satisfactory, 4: clinically unsatisfactory but repairable and 5: clinically poor/irrepairable and in need of replacement. So the scores 1, 2 and 3 considered clinically successful while scores 4 and 5 considered clinically not successful.
- Conditions
- Caries Class Ii
- Being tested
- Bulk-fill composite (X-tra Fil), flowable Bulk-fill composite (X-tra Base), compothixo oscillating packing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk-fill composite (X-tra Fil)Other
Bulk fill resin composite
flowable Bulk-fill composite (X-tra Base)Other
flowable resin composite
compothixo oscillating packingDevice
oscillating packing device
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | teeth will be restored with the packable Bulk-fill composite (X-tra Fil) with a single increment of 4 mm starting with the proximal boxes and cured for 10 s Receives: Other: Bulk-fill composite (X-tra Fil) |
| Snowplow" technique | Experimental | teeth will be restored using Snowplow technique where a 1 mm layer of flowable Bulk-fill composite (X-tra Base) will be deposited at the gingival margin of the prepared teeth and kept uncured. Then pushing a heavily filled packable nanohybrid resin composite (X-tra Fil) into the uncured flowable composite.
The combined layer of flowable and restorative composites will be then cured using LED curing unit for 10 s Receives: Other: Bulk-fill composite (X-tra Fil); Other: flowable Bulk-fill composite (X-tra Base) |
| Oscillating technique | Experimental | teeth will be restored using oscillating technique where the packable Bulk-fill composite material will be placed in bulk to fill the prepared cavity using a plastic filling instrument then the compothixo oscillating packing instrument will be used The oscillation energy (140 Hz) will be applied for 30 s, during which the composite will be adapted to all the cavity walls, and then light cured for 10 s. Receives: Other: Bulk-fill composite (X-tra Fil); Device: compothixo oscillating packing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation of restorations
magnifying loupes (4.5x; Carl Zeiss GmbH, Jena, Germany) will be recommended for evaluation. In addition, a set of blunt explorers, straight and double angled for proximal sites, with different blunt tips of 50, 150, and 250 μm will be utilized to assess the gap size between tooth and restoration. The explorer was drawn across the restoration's surface toward the tooth to detect marginal ditching, irregularities or fracture. If the explorer catches, it means the restoration's edges haven't adapted closely to the tooth structure
Measured: at baseline (immediately after restoration), after 3 months, 6 months, and 12 months
Radiographic examination of the restorations
A scale of 5 pints 1-5 , where 1 consider no pathology with harmonious transition between tooth and restoration 2 mean small visible but acceptable excess or gap 3 means gaps or excess still within acceptable range 4 means gaps or marked excess material in inter radicular 5 means gaps or secondary caries or apical pathology or fracture
Measured: at baseline (immediately after restoration), after 3 months, 6 months, and 12 months
postoperative sensitivity and tooth vitality using VAS
Intensity will be assessed also with a visual analogue scale (VAS) which is a tool widely used to measure pain. The Visual Analogue Scale (VAS) consists of a 100 mm horizontal line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. Using a ruler, the score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Score less than 5 mm will be labeled as no pain, scores from 5 to 44 mm will be labeled as mild pain, scores from 45 to 74 mm will be labeled as moderate pain, and scores 75 mm and greater will be labeled as sever pain.
Measured: at baseline (immediately after restoration), after 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start25 Jan 2024
- Primary completion2 Feb 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries Class IiStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma hosny, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033650
- Sponsor's protocol ID
- 906/2024
- Acronym
- RCT
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 24 Jun 2025
- Results posted
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Performance of Bulk Fill Resin Composite Restorations Using Snow Plow Versus Oscillating Packing Technique: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07033650
- Acronym / sponsor ID
- RCT / 906/2024
- Conditions
- Caries Class Ii
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 24 Jun 2025 (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 is a randomized, controlled, double-blinded clinical trial (the patient and the examiners are blind to the group assignment). Eligible patients will be examined clinically and radiographically using bite-wing radiography, and recruited according to the previously mentioned inclusion and exclusion criteria. All participants will sign written informed consents after being completely aware of the aim, settings, procedures, benefits and potential side effects of the study. Each tooth will be assigned by a number; R1 (Bulk fill RC), R2 (Snow plow tech) and R3 (Oscillating tech). Restoration numbers will be concealed in an opaque sealed envelope that will be held by a facilitator who will not involve in any of the phases of the clinical trial. Every patient will choose an envelope for each tooth. Patients and examiners will be blinded to the material assignment; the operator also will be blinded for the type of restoration during tooth preparation and will be informed only at the time of restoration placement.
Each case will be evaluated according to FDI criteria, based on both functional (Fracture of material and retention, Marginal adaptation, Occlusal contour and wear, Proximal contact point and food impaction, and Radiographic examination) and biological (Postoperative sensitivity, Recurrence of caries and Tooth integrity) properties. Bitewing radiographs and intra-oral photographs will be also used for assessment of all restorations.
Assessment of postoperative sensitivity and tooth vitality will be carried out on the patient by application of a cold stimulus (e.g. a blast of cold air). Postoperative sensitivity will be recorded at the time of restoration placement, and throughout all follow-up appointments, and include type of pain, discomfort and duration, and/or on stimulus at clinical assessment and should always be compared with the response of adjacent vital teeth. Intensity will be assessed also with a visual analogue scale (VAS) which is a commonly used tool for measuring pain.
On a scale of 1 to 5, restorations will be rated as follows; score 1: clinically excellent/very good, 2: clinically good, 3: clinically satisfactory, 4: clinically unsatisfactory but repairable and 5: clinically poor/irrepairable and in need of replacement. So the scores 1, 2 and 3 considered clinically successful while scores 4 and 5 considered clinically not successful.
Detailed description
This is a randomized, controlled, double-blinded clinical trial (the patient and the examiners are blind to the group assignment). The approval of Ethical committee of the Faculty of Dentistry, Suez Canal University, will be taken. This study will be carried on apparently healthy patients of age group 21-50 years, with at least three occluso-proximal cavitated dentinal lesion on the posterior molars, the patients who will agree to participate in this study will sign an informed consent. Also it will be reported according to the protocol established by CONSORT guidelines to ensure transparent and complete reporting.
Patients will be recruited from outpatient clinic of Operative Dentistry Department in Faculty of Dentistry, Suez Canal University. Eligible patients will be examined clinically and radiographically using bite-wing radiography, and recruited according to the previously mentioned inclusion and exclusion criteria. All participants will sign written informed consents after being completely aware of the aim, settings, procedures, benefits and potential side effects of the study. The data from the study and consent forms will be written in Arabic so that every patient could understand them. Patients will be only admitted to the study after signing the informed consent.
Simple randomization will be assigned for 29 participants. Every patient will be diagnosed by examiners for three posterior class II carious lesions. Each tooth will be assigned by a number; R1 (Bulk fill RC), R2 (Snow plow tech) and R3 (Oscillating tech). Restoration numbers will be concealed in an opaque sealed envelope that will be held by a facilitator who will not involve in any of the phases of the clinical trial. Every patient will choose an envelope for each tooth. Patients and examiners will be blinded to the material assignment; the operator also will be blinded for the type of restoration during tooth preparation and will be informed only at the time of restoration placement.
Each case will be evaluated according to FDI criteria, based on both functional (Fracture of material and retention, Marginal adaptation, Occlusal contour and wear, Proximal contact point and food impaction, and Radiographic examination) and biological (Postoperative sensitivity, Recurrence of caries and Tooth integrity) properties. Assessment of restorations will be performed clinically by visual inspection using magnification loupes (4.5x; Carl Zeiss GmbH, Jena, Germany), dental mirrors, a light source and FDI recommended probes with different tip diameters of 150 and 250 micrometer diameter (150x and 250x, Deppeler, Switzerland) . These probes will be used specially for evaluation of both marginal adaptation (functional property) and tooth integrity of enamel cracks and tooth fractures (biological property). Bitewing radiographs and intra-oral photographs will be also used for assessment of all restorations.
Assessment of postoperative sensitivity and tooth vitality will be carried out on the patient by application of a cold stimulus (e.g. a blast of cold air). Postoperative sensitivity will be recorded at the time of restoration placement, and throughout all follow-up appointments, and include type of pain, discomfort and duration, and/or on stimulus at clinical assessment and should always be compared with the response of adjacent vital teeth. Transient pain brought on by stimulation will be acceptable, while persistent pain renders the restoration unacceptable and necessitates intervention to resolve the problem. Intensity will be assessed also with a visual analogue scale (VAS) which is a commonly used tool for measuring pain.
On a scale of 1 to 5, restorations will be rated as follows; score 1: clinically excellent/very good, 2: clinically good, 3: clinically satisfactory, 4: clinically unsatisfactory but repairable and 5: clinically poor/irrepairable and in need of replacement. So the scores 1, 2 and 3 considered clinically successful while scores 4 and 5 considered clinically not successful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Bulk-fill composite (X-tra Fil)teeth will be restored with the packable Bulk-fill composite (X-tra Fil) with a single increment of 4 mm starting with the proximal boxes and cured for 10 s |
| Snowplow" technique | Experimental | Other: Bulk-fill composite (X-tra Fil), Other: flowable Bulk-fill composite (X-tra Base)teeth will be restored using Snowplow technique where a 1 mm layer of flowable Bulk-fill composite (X-tra Base) will be deposited at the gingival margin of the prepared teeth and kept uncured. Then pushing a heavily filled packable nanohybrid resin composite (X-tra Fil) into the uncured flowable composite. The combined layer of flowable and restorative composites will be then cured using LED curing unit for 10 s |
| Oscillating technique | Experimental | Other: Bulk-fill composite (X-tra Fil), Device: compothixo oscillating packingteeth will be restored using oscillating technique where the packable Bulk-fill composite material will be placed in bulk to fill the prepared cavity using a plastic filling instrument then the compothixo oscillating packing instrument will be used The oscillation energy (140 Hz) will be applied for 30 s, during which the composite will be adapted to all the cavity walls, and then light cured for 10 s. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Each patient should have at least three occluso-proximal carious lesions in the posterior molars in three different quadrants (two upper and one lower)
- Only co-operative patients approving to participate in the trial.
Key exclusion criteria (3 listed)
- Patients with disabilities or severe medically compromised.
- Patients with severe bruxism, clenching or temporomandibular joint disorders.
- Patients with allergy to any components of the 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 |
|---|---|---|
| Bulk-fill composite (X-tra Fil)Bulk fill resin composite | Other | Control, Oscillating technique, Snowplow" technique |
| flowable Bulk-fill composite (X-tra Base)flowable resin composite | Other | Snowplow" technique |
| compothixo oscillating packingoscillating packing device | Device | Oscillating technique |
Primary outcome
Adaptation of restorations
Time frame: at baseline (immediately after restoration), after 3 months, 6 months, and 12 months
magnifying loupes (4.5x; Carl Zeiss GmbH, Jena, Germany) will be recommended for evaluation. In addition, a set of blunt explorers, straight and double angled for proximal sites, with different blunt tips of 50, 150, and 250 μm will be utilized to assess the gap size between tooth and restoration. The explorer was drawn across the restoration's surface toward the tooth to detect marginal ditching, irregularities or fracture. If the explorer catches, it means the restoration's edges haven't adapted closely to the tooth structure
Radiographic examination of the restorations
Time frame: at baseline (immediately after restoration), after 3 months, 6 months, and 12 months
A scale of 5 pints 1-5 , where 1 consider no pathology with harmonious transition between tooth and restoration 2 mean small visible but acceptable excess or gap 3 means gaps or excess still within acceptable range 4 means gaps or marked excess material in inter radicular 5 means gaps or secondary caries or apical pathology or fracture
postoperative sensitivity and tooth vitality using VAS
Time frame: at baseline (immediately after restoration), after 3 months, 6 months, and 12 months
Intensity will be assessed also with a visual analogue scale (VAS) which is a tool widely used to measure pain. The Visual Analogue Scale (VAS) consists of a 100 mm horizontal line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. Using a ruler, the score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Score less than 5 mm will be labeled as no pain, scores from 5 to 44 mm will be labeled as mild pain, scores from 45 to 74 mm will be labeled as moderate pain, and scores 75 mm and greater will be labeled as sever pain.
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 24 Jun 2025.
- 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 Bulk-fill composite (X-tra Fil), flowable Bulk-fill composite (X-tra Base) and compothixo oscillating packing in people with Caries Class Ii, run by Suez Canal 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 2 inclusion and 3 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 24 Jun 2025. 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?
Adaptation of restorations (time frame: at baseline (immediately after restoration), after 3 months, 6 months, and 12 months). The study lists 3 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 24 Jun 2025.