Alkasite-based RestorationsRestorationsNCT07263555
Clinical Performance of Alkasite-based Restorations in Children
A study testing Alkasite-based composite restorations and Nano-hybrid resin composite in people with Alkasite-based Restorations and Nano-hybrid Resin Composite, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate and compare the clinical performance of alkasite-based resin and nanohybrid composite resin materials in the restoration of occlusal carious lesions in primary molars of children. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Alkasite-based Restorations, Nano-hybrid Resin Composite
- What is being tested?
- Alkasite-based composite restorations and Nano-hybrid resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Who may be able to join
- • Children aged 4-6 years of both sexes.
- Cooperative children.
- Apparently medically fit children according to parental history.
- Children whose parents agree to sign the informed consent.
- Children whose parents will be able to attend the follow-up.
- Teeth:
- Primary molars with occlusal carious lesions (Class I), indicated for direct restorations.
- Teeth without signs of pulpal involvement, abscess, or fractures.
Who cannot join
- Children:
- Children with systemic or mental disorders.
- Children whose parents refused to sign the informed consent.
- Noncompliant parent.
- Uncooperative children.
- Teeth:
Show all 9Show fewer
- Teeth with deep caries involving the pulp or clinical signs of pulpal infection (e.g., swelling, sinus, fistula, pathological mobility).
- Teeth with periapical pathology, internal or external root resorption, or mobility.
- Non-restorable teeth or lacking sufficient structure for restoration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yusra Hashim Khogali, Bachelor's degree in dentistry contact
Egypt1 site
Cairo University
Cairo, Cairo Governorate
Manal Ahmed Elsayed, Dectorate degree
Rana Tarek Bartaw, Master's degree
About this study
Official title: Clinical Performance of Alkasite-Based Resin Versus Nanohybrid Composite Resin Restorations for Occlusal Carious Lesions in Primary Molars: A Randomized Clinical Trial
The aim of this study is to evaluate and compare the clinical performance of alkasite-based resin and nanohybrid composite resin materials in the restoration of occlusal carious lesions in primary molars of children.
Read the detailed description
This randomized clinical trial aims to evaluate and compare the clinical performance of an alkasite-based resin restorative material (Cention N®) and a nanohybrid composite resin (TPH Spectra ST Universal Composite) in restoring occlusal carious lesions (Class I) in primary molars among children aged 4-6 years. Participants will be randomly allocated in a 1:1 ratio into two parallel groups and followed for a period of 12 months. The primary outcome will be the incidence of secondary caries assessed at 3, 6, and 12 months using the United States Public Health Service (USPHS) criteria, which grades restorations from Alpha (ideal/excellent) to Delta (failure). Secondary outcomes will include the evaluation of restoration fracture, marginal adaptation, marginal discoloration, surface roughness, and retention, all assessed at the same intervals using the same USPHS criteria.
- Being tested
- Alkasite-based composite restorations, Nano-hybrid resin composite
- Keywords
- Alkasite-based Restorations, Cention N, Nano-hybrid resin composite, clinical performance, secordary caries, Children, Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkasite-based composite restorationsOther
Also called Cention N
Alkasite-based restorations will be used in the treatment of class I carious lesion in primary molars.
Nano-hybrid resin compositeOther
Nanohybrid composite will be used in the restoration of Class I carious lesions in primary molars.
| Study group | Role | What they receive |
|---|---|---|
| Alkasite-based Restorations (Cention N) | Experimental | The children assigned to this intervention group will have alkasite-based restorations for the treatment of Class I carious lesion in primary molars. Receives: Other: Alkasite-based composite restorations |
| Nano-hybrid composite resin restoration (TPH Spectra ST Universal Composite). | Active comparator | The children assigned to the comparator group will undergo class I cavity restorations using nano-hybrid resin composite Receives: Other: Nano-hybrid resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of secondary caries
The primary outcome of this study will be the evaluation of secondary caries incidence at 3, 6, and 12 months following restoration. Assessment will be carried out using the United States Public Health Service (USPHS) criteria, with restorations scored on a scale ranging from Alpha (clinically excellent) to Delta (clinically unacceptable.
Each restoration will be scored as Alpha (A) if there is no evidence of secondary caries and the tooth-restoration interface remains intact. A score of Bravo (B) will indicate a questionable or suspicious area, such as slight marginal staining without definite cavitation. Charlie (C) will be assigned when definite secondary caries are observed, including softness or cavitation at the restoration margin, necessitating replacement of the restoration. Delta (D) will be used for severe carious lesions extending beneath the restoration, requiring immediate intervention.
Measured: 12 months
Secondary outcomes (1)
clinical evaluation of restoration fracture
The secondary outcomes will include the clinical evaluation of restoration fracture at 3, 6, and 12 months. The occurrence of restoration fracture will be evaluated using the United States Public Health Service (USPHS) criteria. Each restoration will be scored as Alpha (A) if no fracture is present and the restoration remains intact. A score of Bravo (B) will indicate minor chipping or superficial fracture that does not compromise function. Charlie (C) will be assigned when a fracture is evident that affects the integrity or function of the restoration, necessitating repair or replacement. Delta (D) will be used for severe fracture resulting in complete loss of the restoration, requiring immediate replacement.
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 posted4 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alkasite-based RestorationsStudies 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
- The included children with class I cavity carious lesions will be assigned to either alkasite-based restoration (Intervention group) or Nano-hybrid resin composite (Comparison group)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusra hashim Mohamed kheir khogali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263555
- Sponsor's protocol ID
- Alkasite filling and caries
- Acronym
- Restorations
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not determined yet.
Publications
Attia, R., Sabry, R., Elafefy, A., & Essa, M. (2022). Clinical Performance of Alkasite Dental Material and High Viscosity Glass Ionomer Restorations in Class I Cavities. Comparative Study for One Year Follow Up. Egyptian Dental Journal, 68(4), 3881-3894.
Arora D, Jain M, Suma Sogi HP, Shahi P, Gupta I, Sandhu M. In vivo evaluation of clinical performance of Cention N and glass ionomer cement in proximal restorations of primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):23-29. doi: 10.4103/jisppd.jisppd_108_21.
PubMed 35439879
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Alkasite-Based Resin Versus Nanohybrid Composite Resin Restorations for Occlusal Carious Lesions in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07263555
- Acronym / sponsor ID
- Restorations / Alkasite filling and caries
- Keywords
- Alkasite-based Restorations, Cention N, Nano-hybrid resin composite, clinical performance, secordary caries, Children, Class I
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 4 Dec 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.
The aim of this study is to evaluate and compare the clinical performance of alkasite-based resin and nanohybrid composite resin materials in the restoration of occlusal carious lesions in primary molars of children.
Detailed description
This randomized clinical trial aims to evaluate and compare the clinical performance of an alkasite-based resin restorative material (Cention N®) and a nanohybrid composite resin (TPH Spectra ST Universal Composite) in restoring occlusal carious lesions (Class I) in primary molars among children aged 4-6 years. Participants will be randomly allocated in a 1:1 ratio into two parallel groups and followed for a period of 12 months. The primary outcome will be the incidence of secondary caries assessed at 3, 6, and 12 months using the United States Public Health Service (USPHS) criteria, which grades restorations from Alpha (ideal/excellent) to Delta (failure). Secondary outcomes will include the evaluation of restoration fracture, marginal adaptation, marginal discoloration, surface roughness, and retention, all assessed at the same intervals using the same USPHS criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The included children with class I cavity carious lesions will be assigned to either alkasite-based restoration (Intervention group) or Nano-hybrid resin composite (Comparison group)
| Arm | Type | Receives |
|---|---|---|
| Alkasite-based Restorations (Cention N) | Experimental | Other: Alkasite-based composite restorationsThe children assigned to this intervention group will have alkasite-based restorations for the treatment of Class I carious lesion in primary molars. |
| Nano-hybrid composite resin restoration (TPH Spectra ST Universal Composite). | Active comparator | Other: Nano-hybrid resin compositeThe children assigned to the comparator group will undergo class I cavity restorations using nano-hybrid resin composite |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- • Children aged 4-6 years of both sexes.
- Primary molars with occlusal carious lesions (Class I), indicated for direct restorations.
- Teeth without signs of pulpal involvement, abscess, or fractures.
Key exclusion criteria (9 listed)
- Children with systemic or mental disorders.
- Children whose parents refused to sign the informed consent.
- Noncompliant parent.
- Uncooperative children.
- Teeth with deep caries involving the pulp or clinical signs of pulpal infection (e.g., swelling, sinus, fistula, pathological mobility).
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-based composite restorationsAlso: Cention NAlkasite-based restorations will be used in the treatment of class I carious lesion in primary molars. | Other | Alkasite-based Restorations (Cention N) |
| Nano-hybrid resin compositeNanohybrid composite will be used in the restoration of Class I carious lesions in primary molars. | Other | Nano-hybrid composite resin restoration (TPH Spectra ST Universal Composite). |
Primary outcome
Incidence of secondary caries
Time frame: 12 months
The primary outcome of this study will be the evaluation of secondary caries incidence at 3, 6, and 12 months following restoration. Assessment will be carried out using the United States Public Health Service (USPHS) criteria, with restorations scored on a scale ranging from Alpha (clinically excellent) to Delta (clinically unacceptable. Each restoration will be scored as Alpha (A) if there is no evidence of secondary caries and the tooth-restoration interface remains intact. A score of Bravo (B) will indicate a questionable or suspicious area, such as slight marginal staining without definite cavitation. Charlie (C) will be assigned when definite secondary caries are observed, including softness or cavitation at the restoration margin, necessitating replacement of the restoration. Delta (D) will be used for severe carious lesions extending beneath the restoration, requiring immediate intervention.
1 secondary outcome
clinical evaluation of restoration fracture
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- BackgroundAttia, R., Sabry, R., Elafefy, A., & Essa, M. (2022). Clinical Performance of Alkasite Dental Material and High Viscosity Glass Ionomer Restorations in Class I Cavities. Comparative Study for One Year Follow Up. Egyptian Dental Journal, 68(4), 3881-3894.
- Results publication: PubMed 35439879Arora D, Jain M, Suma Sogi HP, Shahi P, Gupta I, Sandhu M. In vivo evaluation of clinical performance of Cention N and glass ionomer cement in proximal restorations of primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):23-29. doi: 10.4103/jisppd.jisppd_108_21.
- Individual participant dataSharing planned: No. Not determined yet.
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.
Yusra Hashim Khogali, Bachelor's degree in dentistry contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alkasite-based composite restorations and Nano-hybrid resin composite in people with Alkasite-based Restorations and Nano-hybrid Resin Composite, 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 9 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: opening soon, as of the sponsor's last update on 4 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusra Hashim Khogali, Bachelor's degree in dentistry (+1(438)8766528, Yusra.kheir@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of secondary caries (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 NCT07263555, which also lists 2 linked publications.
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 4 Dec 2025.