Dental CariesNCT05149209
Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions
A study testing cervical restoration in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- cervical restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 30 Dec 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- a)Inclusion Criteria of participants:
- Male or female gender.
- Only co-operative patients will be approved to participate in the trial.
- Medically free adult patients.
- The age range of the patients is 18-40 years. b)Inclusion Criteria of teeth:
- Small to moderate cervical lesion.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Caries extension shouldn't exceed mesiodistal width and inciso(occluso)-gingival length not exceed incisal (occlusal) one third.
Who cannot join
- a)Exclusion criteria of participants:
- Allergic history concerning methacrylates
- Pregnancy
- Heavy smoking; xerostomia
- Lack of compliance
- Patients with disabilities.
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- Patients having systemic diseases or severe medically compromised.
- Patients with severe bruxism, clenching, or temporomandibular joint disorders.
- b)Exclusion criteria of the teeth:
- Deep defects (close to the pulp, less than 1 mm distance).
- 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.
Egypt1 site
Nourhan Khaled Mohamed Samir
Cairo, Maadi, 11728
Nourhan K Mohamed, B.D.S., 01003787886 ext. 002, Nourhankhaled@dentistry.cu.edu.eg
Nourhan K Mohamed, B.D.S
About this study
Official title: One-Year Clinical Evaluation of a Fluoride, Calcium and Phosphate-Releasing New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions: A Randomized Clinical Trial.
- This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up.
- The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.
Read the detailed description
two groups of 30 patients will receive cervical restorations by using calcium and phosphate releasing hybrid restorative material (Activa™ Presto, Pulpdent®, USA), or a fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). Then these restorations will be evaluated at baseline, 3 months, 6 months, 9 months, and 12 months according to modified USPHS criteria in terms of marginal adaptation, Marginal discoloration, recurrent caries, retention, surface texture, and Post-operative sensitivity.
- Examination and selection of all patients will be done according to inclusion and exclusion criteria.
- A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation followed by the placement of restorative material according to the randomization sequence.
- For the intervention: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride, calcium, and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA) using a 19-gauge applicator tip on the syringe and light-curing for 20 seconds between each 2mm layer.
- For the control group: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan) and will be light polymerized using a light-emitting diode (LED) light-curing unit for 10 seconds between each 2mm layer.
- Conditions
- Dental Caries
- Being tested
- cervical restoration
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical restorationProcedure or surgery
A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation will be done. Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces. Followed by, placement of restorative material according to the randomization sequence. Finally, restoration finishing and polishing will be done.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA). | Experimental | ACTIVA Presto is a novel bioactive material with a mineral-enriched hydrophilic resin base and a patented rubberized component that resists abrasion and wear with high release and recharge of not only fluoride but also calcium and phosphate ions. It doesn't contain BIS-GMA, Bisphenol A, or BPA derivatives. Receives: Procedure: cervical restoration |
| Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). | Active comparator | Giomer is a hybrid restorative material that contains a resin base and pre-reacted glass ionomer. S-PRG (surface reaction type) technology provides some properties of GI such as fluoride release and recharge which helps prevent recurrent caries. Receives: Procedure: cervical restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
The restoration will be clinically assessed by visual inspection and explorer. Restorations will be given a score using modified USPHS criteria:
Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, the explorer will penetrate Charlie: Crevice in which dentin is exposed
Measured: one year
Secondary outcomes (5)
Marginal Discoloration
Clinical evaluation by visual inspection and mirror if needed using modified USPHS criteria. Restorations will be given the score:
Alfa if No discoloration Bravo if Non penetrating marginal discoloration which can be polished away Charlie if Discoloration with penetration in pulpal direction.
Measured: one year
Retention
Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria :
Alfa if restoration is retained and there is no loss of restoration. Charlie if loss of restoration.
Measured: one year
Secondary caries
Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria:
Alfa if no recurrent caries is detected, charlie if recurrent caries is detected.
.
Measured: one year
surface texture
Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria:
Alfa if restoration is enamel-like surface Bravo if Surface rougher than enamel, clinically acceptable Charlie if Surface is unacceptably rough.
Measured: one year
postoperative sensitivity
Verbal evaluation by asking the patient. Restorations will be given a score according to modified USPHS criteria:
Alfa if not present Bravo if sensitive but diminishing in intensity Charlie if constant sensitivity not diminishing.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start15 Dec 2021 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Khaled Mohamed Samir, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149209
- Sponsor's protocol ID
- cons2021
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * Full protocol will be published online in Clinicaltrials.gov to avoid repetition, and keep the integrity of the research work. * Thesis will be discussed and defended in front of a judging committee. * The study will be published to report the results of this clinical trial.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Year Clinical Evaluation of a Fluoride, Calcium and Phosphate-Releasing New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05149209
- Acronym / sponsor ID
- cons2021
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 Dec 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.
- This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up.
- The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.
Detailed description
two groups of 30 patients will receive cervical restorations by using calcium and phosphate releasing hybrid restorative material (Activa™ Presto, Pulpdent®, USA), or a fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). Then these restorations will be evaluated at baseline, 3 months, 6 months, 9 months, and 12 months according to modified USPHS criteria in terms of marginal adaptation, Marginal discoloration, recurrent caries, retention, surface texture, and Post-operative sensitivity.
- Examination and selection of all patients will be done according to inclusion and exclusion criteria.
- A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation followed by the placement of restorative material according to the randomization sequence.
- For the intervention: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride, calcium, and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA) using a 19-gauge applicator tip on the syringe and light-curing for 20 seconds between each 2mm layer.
- For the control group: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan) and will be light polymerized using a light-emitting diode (LED) light-curing unit for 10 seconds between each 2mm layer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.
| Arm | Type | Receives |
|---|---|---|
| Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA). | Experimental | Procedure: cervical restorationACTIVA Presto is a novel bioactive material with a mineral-enriched hydrophilic resin base and a patented rubberized component that resists abrasion and wear with high release and recharge of not only fluoride but also calcium and phosphate ions. It doesn't contain BIS-GMA, Bisphenol A, or BPA derivatives. |
| Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). | Active comparator | Procedure: cervical restorationGiomer is a hybrid restorative material that contains a resin base and pre-reacted glass ionomer. S-PRG (surface reaction type) technology provides some properties of GI such as fluoride release and recharge which helps prevent recurrent caries. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- a)Inclusion Criteria of participants:
Key exclusion criteria (15 listed)
- a)Exclusion criteria of participants:
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 |
|---|---|---|
| cervical restorationA class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation will be done. Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces. Followed by, placement of restorative material according to the randomization sequence. Finally, restoration finishing and polishing will be done. | Procedure or surgery | Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA)., Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). |
Primary outcome
Marginal adaptation
Time frame: one year
The restoration will be clinically assessed by visual inspection and explorer. Restorations will be given a score using modified USPHS criteria: Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, the explorer will penetrate Charlie: Crevice in which dentin is exposed
5 secondary outcomes
Marginal Discoloration
Time frame: one year
Retention
Time frame: one year
Secondary caries
Time frame: one year
surface texture
Time frame: one year
postoperative sensitivity
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: Yes. * Full protocol will be published online in Clinicaltrials.gov to avoid repetition, and keep the integrity of the research work. * Thesis will be discussed and defended in front of a judging committee. * The study will be published to report the results of this clinical trial.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical restoration in people with 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 8 inclusion and 15 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 8 Dec 2021. 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 Nourhan K Mohamed, B.D.S (01003787886, nourhankhaled@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal adaptation (time frame: one year). 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 8 Dec 2021.