Occlual CariesNCT06724939
Clinical Evaluation of Self-Adhesive Bulk-Fil Hybrid Composite in Primary Molars
A study testing self-adhesive bulk-fill resin composite in people with Occlual Caries and Proximal Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will evaluate the clinical performance of self-adhesive bulk-fill composite resin in the restoration of occlusal and occluso-proximal lesions in primary molars with hypothesis that there is no difference in the clinical performance of self-adhesive bulk-fill composite and traditional bulk-fill composite… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Occlual Caries, Proximal Caries
- What is being tested?
- self-adhesive bulk-fill resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2022to 19 Jan 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Children with bilateral simple occlusal or occluso-proximal caries in the lower second primary molars.
- Generally healthy children with no systemic disease.
- Cooperative children with a behavior rating of 3 or 4 according to the Frankl Behavior Rating Scale.
Who cannot join
- Pulp exposure or indication for endodontic treatment or extraction.
- Teeth with symptoms such as spontaneous pain, swelling, infection, fistulae, abscesses or tenderness on percussion.
- Parents who weren't available for periodic follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Self-Adhesive Bulk-Fil Hybrid Composite Restoration in Primary Molars
This study will evaluate the clinical performance of self-adhesive bulk-fill composite resin in the restoration of occlusal and occluso-proximal lesions in primary molars with hypothesis that there is no difference in the clinical performance of self-adhesive bulk-fill composite and traditional bulk-fill composite with adhesive over one year observation period
Read the detailed description
Protocol of clinical procedure:After psychological management and preparation of the child, local anesthesia was administered in order to prevent pain upon cavity preparation and maintain the child's cooperation. Involved teeth were isolated using a rubber dam (DuraDam, Klang, Selangor D.E.,Malaysia). All cavities were cleaned and prepared using a high speed carbide bur (#330, MANI Inc, Tokyo, Japan) under a constant copious water-cooling system using a high-speed contra-angled hand piece (Dentsply Sirona, York, PA, USA). All occlusal pits and fissures were included in the cavity design to standardize the preparations. A small sectional contoured metal matrix (TOR VM, Russia) was placed interproximally and fixed with a wedge.
At this point, the operator defined the restorative material to be used by opening the allocation envelope.The cavities were restored in each subgroup with restorative material according to the manufacture instructions as follow:
In subgroup IA and IIA(cotrol groups), a 37% phosphoric acid etchant (Scotchbond Universal Etchant, 3M, ESP) was applied for 15 seconds on the dentine and 30 seconds on the enamel ,followed by washing for 40 seconds with water and gently air dried. The adhesive system (Scotchbond Universal Adhesive, 3M, ESPE, St. Paul, MN, USA) was applied actively to the entire surface using a disposable bond brush, for 20 seconds. The adhesive was dispersed into a thin layer with a gentle stream of air for 5 seconds, followed by light curing for 10 seconds using an LED light-curing unit (BluePhase N, Ivoclar Vivadent AG) with an intensity of 1200 mW/cm². Cavities were filled with FiltekTM Bulk Fill (St. Paul, MN, USA), in one increment and light cured for 20 seconds on each surface of the tooth with the same curing unit.
In subgroup IB and IIB (study groups), The cavities were cleaned using an air-water spray, leaving a moist cavity surface. Surefil one activated capsules (Dentsply Sirona, Konstanz, Germany) were mixed for 10 seconds using a capsule mixer (4200-5000 rpm) following the manufacturer's instructions. The restorative material was promptly dispensed into the prepared cavity using a capsule extruder. The dispensing process began at the cavity's deepest area, with the tip kept close to the bottom. The tip was gradually withdrawn as the cavity was filled in bulk and contoured with a hand instrument.(Following this, the restoration was cured for 20 seconds on each surface of the tooth with the same curing unit.
After that ,the occlusion was checked using articulating paper (Bausch, Nashua, NH, USA). The restorations were finished using a yellow-coded finishing flame stone (MANI Inc., Tokyo, Japan).Final polishing was performed using polishing disks (Soflex, 3M ESPE, MN, USA) while keeping the restoration moist with water spray.
Clinical evaluation: The restorations were evaluated clinically and radiographically according to Modified United States Public Health Organization (USHPS) criteria measuring marginal adaption, surface roughness, anatomic form, postoperative sensitivity, recurrent caries, retention, color match and proximal contact. These items were ranked according to the scores: Alpha -ideal clinical situation; Bravo-clinically acceptable; Charlie-clinically unacceptable situation. The evaluation was done post restoration(baseline) and at follow-up periods of 3, 6, and 12 months
- Conditions
- Occlual Caries, Proximal Caries
- Being tested
- self-adhesive bulk-fill resin composite
- Keywords
- Bulk-fill composite, self-adhesive bulk-fill composite, primary molars, restorative treatment, occlusal lesions, occluso-proximal lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-adhesive bulk-fill resin compositeOther
surefil one self-adhesive bulk-fill composite
| Study group | Role | What they receive |
|---|---|---|
| 3M bulk-fill composite resin class I | Active comparator | class I bulk-fill composite Receives: Other: self-adhesive bulk-fill resin composite |
| 3M bulk-fill compsite resin class II | Active comparator | class I bulk-fill Receives: Other: self-adhesive bulk-fill resin composite |
| surefil one class I | Experimental | class I surefil one Receives: Other: self-adhesive bulk-fill resin composite |
| surefil one class II | Experimental | class II surefil one Receives: Other: self-adhesive bulk-fill resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified United States Public Health Organization (USPHS) criteria for evaluation
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 posted9 Dec 2024
- Study start12 Sep 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion19 Jan 2025 (estimated)
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 Occlual CariesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- The children will be randomly divided into 2 main groups according to the type of carious lesion:Group I occlusal lesions.Group II occluso-proximal lesions. Then the children will be randomly sub grouped according to the type of restorative materials that will be used:Group IA and group IIA with filtek 3M bulk-fill resin composite .Group IB and IIB with surefil one restorative materials
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724939
- Sponsor's protocol ID
- A06020822
- Status last verified
- Oct 2024
- First submitted
- 29 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rathke A, Pfefferkorn F, McGuire MK, Heard RH, Seemann R. One-year clinical results of restorations using a novel self-adhesive resin-based bulk-fill restorative. Sci Rep. 2022 Mar 10;12(1):3934. doi: 10.1038/s41598-022-07965-z.
PubMed 35273277
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Self-Adhesive Bulk-Fil Hybrid Composite Restoration in Primary Molars
- ClinicalTrials.gov ID
- NCT06724939
- Acronym / sponsor ID
- A06020822
- Conditions
- Occlual Caries, Proximal Caries
- Keywords
- Bulk-fill composite, self-adhesive bulk-fill composite, primary molars, restorative treatment, occlusal lesions, occluso-proximal lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 19 Jan 2025 (estimated)
- First posted
- 9 Dec 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.
This study will evaluate the clinical performance of self-adhesive bulk-fill composite resin in the restoration of occlusal and occluso-proximal lesions in primary molars with hypothesis that there is no difference in the clinical performance of self-adhesive bulk-fill composite and traditional bulk-fill composite with adhesive over one year observation period
Detailed description
Protocol of clinical procedure:After psychological management and preparation of the child, local anesthesia was administered in order to prevent pain upon cavity preparation and maintain the child's cooperation. Involved teeth were isolated using a rubber dam (DuraDam, Klang, Selangor D.E.,Malaysia). All cavities were cleaned and prepared using a high speed carbide bur (#330, MANI Inc, Tokyo, Japan) under a constant copious water-cooling system using a high-speed contra-angled hand piece (Dentsply Sirona, York, PA, USA). All occlusal pits and fissures were included in the cavity design to standardize the preparations. A small sectional contoured metal matrix (TOR VM, Russia) was placed interproximally and fixed with a wedge.
At this point, the operator defined the restorative material to be used by opening the allocation envelope.The cavities were restored in each subgroup with restorative material according to the manufacture instructions as follow:
In subgroup IA and IIA(cotrol groups), a 37% phosphoric acid etchant (Scotchbond Universal Etchant, 3M, ESP) was applied for 15 seconds on the dentine and 30 seconds on the enamel ,followed by washing for 40 seconds with water and gently air dried. The adhesive system (Scotchbond Universal Adhesive, 3M, ESPE, St. Paul, MN, USA) was applied actively to the entire surface using a disposable bond brush, for 20 seconds. The adhesive was dispersed into a thin layer with a gentle stream of air for 5 seconds, followed by light curing for 10 seconds using an LED light-curing unit (BluePhase N, Ivoclar Vivadent AG) with an intensity of 1200 mW/cm². Cavities were filled with FiltekTM Bulk Fill (St. Paul, MN, USA), in one increment and light cured for 20 seconds on each surface of the tooth with the same curing unit.
In subgroup IB and IIB (study groups), The cavities were cleaned using an air-water spray, leaving a moist cavity surface. Surefil one activated capsules (Dentsply Sirona, Konstanz, Germany) were mixed for 10 seconds using a capsule mixer (4200-5000 rpm) following the manufacturer's instructions. The restorative material was promptly dispensed into the prepared cavity using a capsule extruder. The dispensing process began at the cavity's deepest area, with the tip kept close to the bottom. The tip was gradually withdrawn as the cavity was filled in bulk and contoured with a hand instrument.(Following this, the restoration was cured for 20 seconds on each surface of the tooth with the same curing unit.
After that ,the occlusion was checked using articulating paper (Bausch, Nashua, NH, USA). The restorations were finished using a yellow-coded finishing flame stone (MANI Inc., Tokyo, Japan).Final polishing was performed using polishing disks (Soflex, 3M ESPE, MN, USA) while keeping the restoration moist with water spray.
Clinical evaluation: The restorations were evaluated clinically and radiographically according to Modified United States Public Health Organization (USHPS) criteria measuring marginal adaption, surface roughness, anatomic form, postoperative sensitivity, recurrent caries, retention, color match and proximal contact. These items were ranked according to the scores: Alpha -ideal clinical situation; Bravo-clinically acceptable; Charlie-clinically unacceptable situation. The evaluation was done post restoration(baseline) and at follow-up periods of 3, 6, and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The children will be randomly divided into 2 main groups according to the type of carious lesion:Group I occlusal lesions.Group II occluso-proximal lesions. Then the children will be randomly sub grouped according to the type of restorative materials that will be used:Group IA and group IIA with filtek 3M bulk-fill resin composite .Group IB and IIB with surefil one restorative materials
| Arm | Type | Receives |
|---|---|---|
| 3M bulk-fill composite resin class I | Active comparator | Other: self-adhesive bulk-fill resin compositeclass I bulk-fill composite |
| 3M bulk-fill compsite resin class II | Active comparator | Other: self-adhesive bulk-fill resin compositeclass I bulk-fill |
| surefil one class I | Experimental | Other: self-adhesive bulk-fill resin compositeclass I surefil one |
| surefil one class II | Experimental | Other: self-adhesive bulk-fill resin compositeclass II surefil one |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Children with bilateral simple occlusal or occluso-proximal caries in the lower second primary molars.
Key exclusion criteria (3 listed)
- Pulp exposure or indication for endodontic treatment or extraction.
- Teeth with symptoms such as spontaneous pain, swelling, infection, fistulae, abscesses or tenderness on percussion.
- Parents who weren't available for periodic follow up.
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 |
|---|---|---|
| self-adhesive bulk-fill resin compositesurefil one self-adhesive bulk-fill composite | Other | 3M bulk-fill composite resin class I, 3M bulk-fill compsite resin class II, surefil one class I, surefil one class II |
Primary outcome
Modified United States Public Health Organization (USPHS) criteria for evaluation
Time frame: one year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 35273277Rathke A, Pfefferkorn F, McGuire MK, Heard RH, Seemann R. One-year clinical results of restorations using a novel self-adhesive resin-based bulk-fill restorative. Sci Rep. 2022 Mar 10;12(1):3934. doi: 10.1038/s41598-022-07965-z.
- 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.
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 self-adhesive bulk-fill resin composite in people with Occlual Caries and Proximal Caries, run by Mansoura 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 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: status not confirmed, as of the sponsor's last update on 9 Dec 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?
Modified United States Public Health Organization (USPHS) criteria for evaluation (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?
On the ClinicalTrials.gov record for NCT06724939, 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 9 Dec 2024.