Cervical LesionNCT04716517
Clinical Evaluation of Bulk-fill Alkasite Restoration Versus Resin Modified Glass Ionomer in Adult With Class V Carious
A study testing Alkasite bioactive restorative material. and Resin Modified Glass Ionomer in people with Cervical Lesion, run by Cairo University.
Trial summary
Cention N will have the same clinical performance as resin-modified glass ionomer in cervical carious lesions. Evaluation of restorations will be done at baseline, six months, and one year according (USPHS) criteria. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Lesion
- What is being tested?
- Alkasite bioactive restorative material. and Resin Modified Glass Ionomer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with High caries risk.
- Patients with poor oral hygiene.
- Patients with untreated cervical caries lesion.
- patient aging ≥18 years.
- Absence of tooth mobility
- Absence of abnormal occlusion.
- Patients with good likelihood of recall availability.
Who cannot join
- Patients with cervical caries lesions need crown restoration.
- Non-vital teeth.
- Evidence of parafunctional habits.
- Teeth supporting removable prosthesis.
- Periapical Abscess or Fistula.
- Patients with systemic disease.
- Patients with xerostomia.
- Participants with a history of allergy to any component of restorations will be used in the study.
About this study
Official title: Clinical Evaluation of Bulk-fill Alkasite Restoration Versus Resin Modified Glass Ionomer in Adult Patients With Class V Carious Lesions Over One Year Period: Randomized Clinical Trial
Cention N will have the same clinical performance as resin-modified glass ionomer in cervical carious lesions. Evaluation of restorations will be done at baseline, six months, and one year according (USPHS) criteria.
Read the detailed description
In this study, Class V carious lesions were restored using two different restorative materials either resin modified glass ionomer or Cention N restorative materials. This study will be held in the restorative clinic at Future University in Egypt. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, 12 their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received. The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received Cention N restorative materials. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year.
The restorations will be clinically examined according to modified USPHS criteria in terms of marginal adaptation, anatomic form, color match, marginal discoloration, secondary caries, postoperative sensitivity and retention. The information that will be obtained will be collected and statistically analyzed
- Conditions
- Cervical Lesion
- Being tested
- Alkasite bioactive restorative material., Resin Modified Glass Ionomer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkasite bioactive restorative material.Other
Also called (Cention N).
Alkasite restorative is a category of filling material, like compomer, and is essentially a subgroup
of the composite resin. Cention N is a urethane dimethacrylate (UDMA)-based, self-curing powder/liquid restorative with optional additional light curing. The liquid comprises of dimethacrylates and initiators, while the powder contains various glass fillers, initiators, and pigments. It is radio opaque and contains alkaline glass fillers capable of releasing fluoride, calcium, and hydroxide ions. Due to the sole use of cross-linking methacrylate monomers in combination with a stable, efficient self-cure initiator, Cention N displays a high polymer network density and degree of polymerization over the complete depth of the restoration.
Resin Modified Glass IonomerOther
The resin-modified glass ionomer materials are hybrid materials of traditional glass ionomer cement with a small addition of light-curing resin, and hence exhibit properties intermediate to the two, with some characteristics superior to conventional glass ionomer materials
| Study group | Role | What they receive |
|---|---|---|
| Cention N | Experimental | Intervention Alkasite Restoration will be used to restore cervical carious in adult patients. Receives: Other: Alkasite bioactive restorative material. |
| Resin Modified Glass Ionomer | Active comparator | Comparator Resin-modified glass ionomer material will be used to restore cervical carious in adult patients. Receives: Other: Resin Modified Glass Ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Marginal adaptation)
(USPHS) criteria
Measured: 12 months
Secondary outcomes (1)
Clinical performance (Anatomical form, Secondary caries, marginal discoloration, Postoperative sensitivity, Color match, Retention)
(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 posted20 Jan 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (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 Cervical LesionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hadeel alsalamony, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716517
- Sponsor's protocol ID
- 381020
- Status last verified
- Jul 2021
- First submitted
- 11 Jan 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Al-Salamony H, Akah M, Naguib EA, Safwat OM. Clinical Evaluation of Bulk-fill Alkasite Restoration vs Resin-modified Glass Ionomer in Class V Carious Lesions: 1-year Randomized Clinical Trial. J Contemp Dent Pract. 2024 Dec 1;25(12):1127-1134. doi: 10.5005/jp-journals-10024-3787.
PubMed 40079991
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bulk-fill Alkasite Restoration Versus Resin Modified Glass Ionomer in Adult Patients With Class V Carious Lesions Over One Year Period: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04716517
- Acronym / sponsor ID
- 381020
- Conditions
- Cervical Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Jan 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.
Cention N will have the same clinical performance as resin-modified glass ionomer in cervical carious lesions. Evaluation of restorations will be done at baseline, six months, and one year according (USPHS) criteria.
Detailed description
In this study, Class V carious lesions were restored using two different restorative materials either resin modified glass ionomer or Cention N restorative materials. This study will be held in the restorative clinic at Future University in Egypt. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, 12 their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received. The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received Cention N restorative materials. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year.
The restorations will be clinically examined according to modified USPHS criteria in terms of marginal adaptation, anatomic form, color match, marginal discoloration, secondary caries, postoperative sensitivity and retention. The information that will be obtained will be collected and statistically analyzed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cention N | Experimental | Other: Alkasite bioactive restorative material.Intervention Alkasite Restoration will be used to restore cervical carious in adult patients. |
| Resin Modified Glass Ionomer | Active comparator | Other: Resin Modified Glass IonomerComparator Resin-modified glass ionomer material will be used to restore cervical carious in adult patients. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with High caries risk.
- Patients with poor oral hygiene.
- Patients with untreated cervical caries lesion.
- patient aging ≥18 years.
- Absence of tooth mobility
Key exclusion criteria (8 listed)
- Patients with cervical caries lesions need crown restoration.
- Non-vital teeth.
- Evidence of parafunctional habits.
- Teeth supporting removable prosthesis.
- Periapical Abscess or Fistula.
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 |
|---|---|---|
| Alkasite bioactive restorative material.Also: (Cention N).Alkasite restorative is a category of filling material, like compomer, and is essentially a subgroup of the composite resin. Cention N is a urethane dimethacrylate (UDMA)-based, self-curing powder/liquid restorative with optional additional light curing. The liquid comprises of dimethacrylates and initiators, while the powder contains various glass fillers, initiators, and pigments. It is radio opaque and contains alkaline glass fillers capable of releasing fluoride, calcium, and hydroxide ions. Due to the sole use of cross-linking methacrylate monomers in combination with a stable, efficient self-cure initiator, Cention N displays a high polymer network density and degree of polymerization over the complete depth of the restoration. | Other | Cention N |
| Resin Modified Glass IonomerThe resin-modified glass ionomer materials are hybrid materials of traditional glass ionomer cement with a small addition of light-curing resin, and hence exhibit properties intermediate to the two, with some characteristics superior to conventional glass ionomer materials | Other | Resin Modified Glass Ionomer |
Primary outcome
(Marginal adaptation)
Time frame: 12 months
(USPHS) criteria
1 secondary outcome
Clinical performance (Anatomical form, Secondary caries, marginal discoloration, Postoperative sensitivity, Color match, Retention)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 40079991Al-Salamony H, Akah M, Naguib EA, Safwat OM. Clinical Evaluation of Bulk-fill Alkasite Restoration vs Resin-modified Glass Ionomer in Class V Carious Lesions: 1-year Randomized Clinical Trial. J Contemp Dent Pract. 2024 Dec 1;25(12):1127-1134. doi: 10.5005/jp-journals-10024-3787.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Alkasite bioactive restorative material. and Resin Modified Glass Ionomer in people with Cervical Lesion, run by Cairo University.
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 7 inclusion and 8 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
(Marginal adaptation) (time frame: 12 months). 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 NCT04716517, 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 28 Jul 2021.