Dental CariesNCT06990945
The Study Aims to Compare the Effectiveness of Mesoporous Bioactive Glass-containing Adhesives vs Conventional Universal Adhesives on the Clinical Performance Composite Restorations Through Promoting Dentin Remineralization After Selective Caries Removal Over a Two-year Follow-up
A study testing Hi-Bond Universal Adhesive and OptiBond Universal Adhesive in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
a two-year, double-blind, randomized controlled trial evaluates the effectiveness of a bioactive glass adhesive (Hi-Bond Universal) versus a conventional adhesive (OptiBond Universal) in Class II carious lesions. Read more about this study
- Who is it for?
- Ages 22 to 42 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Hi-Bond Universal Adhesive and OptiBond Universal Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2025to Dec 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 22 to 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 22 to 42 years.
- Presence of Class II carious lesions in posterior permanent teeth (ICDAS 5 \& 6).
- Radiographic evidence of caries extending to 50% of dentin with a radiopaque layer between the lesion and pulp chamber.
- Teeth with normal pulp vitality confirmed through cold pulp sensibility test.
- Teeth with no periapical pathosis on radiographic examination.
- Good oral hygiene as determined by the attending clinician.
- Willingness to sign the informed consent and comply with the 2-year follow-up protocol.
- Cooperative patients who can attend all follow-up visits.
Who cannot join
- Allergy to any of the restorative materials (OptiBond Universal or Hi-Bond Universal).
- Patients currently undergoing orthodontic treatment with fixed appliances.
- Pregnant women or those planning pregnancy during the study period.
- Patients with systemic diseases that could interfere with dental treatment (e.g., uncontrolled diabetes, cardiovascular diseases).
- Use of analgesics or medications that could mask postoperative sensitivity.
- Teeth with previous restorations or treatment in the target area.
Show all 12Show fewer
- Teeth exhibiting spontaneous pain or lingering pain after sensitivity testing, indicating irreversible pulpitis.
- Negative response in cold pulp sensibility test, indicating pulp necrosis.
- Teeth with periapical radiolucencies or signs of infection.
- Mobile teeth due to periodontal disease or trauma.
- Teeth with extensive structural damage, such as cusp fractures or deep cracks.
- Patients unable to comply with the follow-up schedule.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed Hesham Samaha, PhD candidate Conservative Dep contact
Prof. Dr. Rasha Raafat Main Supervisor / Data Monitoring, professor conservative depar. contact
About this study
Official title: Clinical Performance And Radiographic Assessment Of Mesoporous Bioactive Glass Adhesive Vs. Universal Adhesive In Class II Carious Lesions
a two-year, double-blind, randomized controlled trial evaluates the effectiveness of a bioactive glass adhesive (Hi-Bond Universal) versus a conventional adhesive (OptiBond Universal) in Class II carious lesions. The study will assess clinical outcomes such as fracture resistance and marginal adaptation and radiographic evidence of dentin remineralization in 80 adult participants. Hypersensitivity and secondary caries development will also be monitored at multiple time points to determine comparative efficacy.
Read the detailed description
This study is a two-year, double-blind, randomized controlled clinical trial designed to compare the clinical performance and radiographic outcomes of a mesoporous bioactive glass adhesive (Hi-Bond Universal) with a conventional universal adhesive (OptiBond Universal) in Class II carious lesions. The trial will enroll 80 participants aged 22 to 42 years, recruited from the Outpatient Clinic of the Conservative Dentistry Department at Cairo University.
Eligible participants presenting with ICDAS 5 and 6 carious lesions in posterior permanent teeth will be randomly assigned to one of two treatment groups. The intervention group will receive the Hi-Bond Universal adhesive, a bioactive glass-modified adhesive intended to promote dentin remineralization and reduce postoperative hypersensitivity through calcium and phosphate ion release. The control group will be treated with OptiBond Universal, a conventional adhesive providing mechanical bonding without bioactive properties.
Clinical outcomes will be evaluated using the FDI World Dental Federation criteria, focusing on functional properties such as fracture resistance, marginal adaptation, and retention. Radiographic assessments will quantify dentin remineralization using digital grayscale analysis. Hypersensitivity will be recorded using a patient-reported Likert scale at baseline, 6, 12, 18, and 24 months.
The primary outcome is the functional integrity of the restorative material, assessed at 24 months. Secondary outcomes include the presence of marginal caries, postoperative hypersensitivity, and radiographic evidence of dentin remineralization. Data will be analyzed using appropriate statistical methods to determine differences between the two adhesive systems.
- Conditions
- Dental Caries
- Being tested
- Hi-Bond Universal Adhesive, OptiBond Universal Adhesive
- Keywords
- Class II Carious Lesions, Dentin Remineralization, Dental Adhesives, Bioactive Glass, Restorative Dentistry, Hypersensitivity
- Medical subject headings
- Dental Caries, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hi-Bond Universal AdhesiveDevice
A bioactive glass adhesive containing mesoporous bioactive glass designed to promote dentin remineralization, manufactured by Mediclus, Korea. It releases calcium and phosphate ions to enhance dentin sealing and reduce hypersensitivity
The adhesive will be applied after selective caries removal following a standardized protocol:
Selective enamel etching with 37% phosphoric acid for 15 seconds.
Application of HI Bond Universal adhesive with agitation for 20 seconds.
Light curing for 20 seconds using a LED curing device.
Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA).
Occlusal adjustment, finishing, and polishing.
OptiBond Universal AdhesiveDevice
conventional universal adhesive designed for bonding composite restorations to enamel and dentin.
The adhesive will be applied after selective caries removal following a standardized protocol:
Selective enamel etching with 37% phosphoric acid for 15 seconds.
Application of OptiBond Universal adhesive with agitation for 20 seconds.
Light curing for 20 seconds using a LED curing device.
Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA).
Occlusal adjustment, finishing, and polishing.
| Study group | Role | What they receive |
|---|---|---|
| Optibond Universal adhesive | Active comparator | Participants in the control group will receive a conventional universal adhesive (OptiBond Universal) applied after selective caries removal. The adhesive will be applied according to the manufacturer's instructions, followed by placement of a nano-hybrid composite (Optishade Universal Kerr Dental). Receives: Device: OptiBond Universal Adhesive |
| Intervention - Hi-Bond Universal Adhesive | Experimental | Participants in this group will receive a bioactive glass-modified adhesive, Hi-Bond Universal (Mediclus, Korea). This adhesive releases calcium and phosphate ions to enhance dentin remineralization and reduce hypersensitivity, applied after selective caries removal and followed by composite restoration. Receives: Device: Hi-Bond Universal Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance - Functional Properties (Retention loss)
The clinical performance of the adhesive systems will be assessed based on the functional properties, specifically focusing on the retention of the composite Restoration Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)
Measured: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Secondary outcomes (8)
Clinical Performance - Functional Properties (fracture of the material)
Assessment of fracture resistance of the restorative materials (Hi-Bond Universal vs. OptiBond Universal) using the FDI Criteria. This includes the evaluation of material integrity, chipping, fractures, and overall structural durability of the restorations.Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)
Measured: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Approximal Anatomical Form
Assessment of contact points and contours of the restoration, focusing on anatomical integrity and function.
Assessment Method: FDI Criteria Scores (1-5)
Measured: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Marginal Adaptation
Evaluation of the marginal adaptation of the adhesive systems using clinical criteria. This outcome assesses the adhesive's ability to seal restoration margins effectively.Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)
Measured: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Clinical Performance - Biological Properties (Caries at Restoration Margins)
The presence of caries at restoration margins will be assessed using clinical examinations. The objective is to evaluate the adhesive's ability to prevent secondary caries development at the margins of the restorations.Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)
Measured: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Postoperative Hypersensitivity
Assessment of patient-reported tooth hypersensitivity following adhesive application and composite restoration.Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)
Measured: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Adjacent Mucosa Condition
Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)
Measured: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Esthetic Properties - Staining (Surface and Margin)
Clinical evaluation of staining at the surface and margins of the restoration to assess esthetic integrity.
Assessment Method: FDI Criteria Scores (1-5)
Measured: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Remaining Dentin Bridge - Remineralization
Evaluation of remineralization at the remaining dentin bridge using digital radiography and grayscale analysis.
Assessment Method: Digital Radiography (Grayscale values 0-255)
Measured: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (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
- the study is a 2-year, double-blind, randomized controlled trial with two parallel arms. Participants with Class II carious lesions will be randomly assigned to receive either a mesoporous bioactive glass adhesive (Hi-Bond Universal) or a conventional universal adhesive (OptiBond Universal). Clinical and radiographic assessments will be conducted at baseline, 6 months, 12 months, 18 months, and 24 months to evaluate the adhesive's performance in terms of fracture resistance, retention, marginal adaptation, dentin remineralization, and hypersensitivity.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- providing support: Equipment and some consumables by Department of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Cairo University
- Responsible party
- Principal investigator, Ahmed Hesham samaha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990945
- Sponsor's protocol ID
- CU-2025-05
- Other IDs
- cu-fund-202505
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance And Radiographic Assessment Of Mesoporous Bioactive Glass Adhesive Vs. Universal Adhesive In Class II Carious Lesions
- ClinicalTrials.gov ID
- NCT06990945
- Acronym / sponsor ID
- CU-2025-05
- Conditions
- Dental Caries
- Keywords
- Class II Carious Lesions, Dentin Remineralization, Dental Adhesives, Bioactive Glass, Restorative Dentistry, Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- providing support: Equipment and some consumables by Department of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Cairo University
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 May 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.
a two-year, double-blind, randomized controlled trial evaluates the effectiveness of a bioactive glass adhesive (Hi-Bond Universal) versus a conventional adhesive (OptiBond Universal) in Class II carious lesions. The study will assess clinical outcomes such as fracture resistance and marginal adaptation and radiographic evidence of dentin remineralization in 80 adult participants. Hypersensitivity and secondary caries development will also be monitored at multiple time points to determine comparative efficacy.
Detailed description
This study is a two-year, double-blind, randomized controlled clinical trial designed to compare the clinical performance and radiographic outcomes of a mesoporous bioactive glass adhesive (Hi-Bond Universal) with a conventional universal adhesive (OptiBond Universal) in Class II carious lesions. The trial will enroll 80 participants aged 22 to 42 years, recruited from the Outpatient Clinic of the Conservative Dentistry Department at Cairo University.
Eligible participants presenting with ICDAS 5 and 6 carious lesions in posterior permanent teeth will be randomly assigned to one of two treatment groups. The intervention group will receive the Hi-Bond Universal adhesive, a bioactive glass-modified adhesive intended to promote dentin remineralization and reduce postoperative hypersensitivity through calcium and phosphate ion release. The control group will be treated with OptiBond Universal, a conventional adhesive providing mechanical bonding without bioactive properties.
Clinical outcomes will be evaluated using the FDI World Dental Federation criteria, focusing on functional properties such as fracture resistance, marginal adaptation, and retention. Radiographic assessments will quantify dentin remineralization using digital grayscale analysis. Hypersensitivity will be recorded using a patient-reported Likert scale at baseline, 6, 12, 18, and 24 months.
The primary outcome is the functional integrity of the restorative material, assessed at 24 months. Secondary outcomes include the presence of marginal caries, postoperative hypersensitivity, and radiographic evidence of dentin remineralization. Data will be analyzed using appropriate statistical methods to determine differences between the two adhesive systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- the study is a 2-year, double-blind, randomized controlled trial with two parallel arms. Participants with Class II carious lesions will be randomly assigned to receive either a mesoporous bioactive glass adhesive (Hi-Bond Universal) or a conventional universal adhesive (OptiBond Universal). Clinical and radiographic assessments will be conducted at baseline, 6 months, 12 months, 18 months, and 24 months to evaluate the adhesive's performance in terms of fracture resistance, retention, marginal adaptation, dentin remineralization, and hypersensitivity.
| Arm | Type | Receives |
|---|---|---|
| Optibond Universal adhesive | Active comparator | Device: OptiBond Universal AdhesiveParticipants in the control group will receive a conventional universal adhesive (OptiBond Universal) applied after selective caries removal. The adhesive will be applied according to the manufacturer's instructions, followed by placement of a nano-hybrid composite (Optishade Universal Kerr Dental). |
| Intervention - Hi-Bond Universal Adhesive | Experimental | Device: Hi-Bond Universal AdhesiveParticipants in this group will receive a bioactive glass-modified adhesive, Hi-Bond Universal (Mediclus, Korea). This adhesive releases calcium and phosphate ions to enhance dentin remineralization and reduce hypersensitivity, applied after selective caries removal and followed by composite restoration. |
Who may qualify
- Ages
- 22 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult patients aged 22 to 42 years.
- Presence of Class II carious lesions in posterior permanent teeth (ICDAS 5 \& 6).
- Radiographic evidence of caries extending to 50% of dentin with a radiopaque layer between the lesion and pulp chamber.
- Teeth with normal pulp vitality confirmed through cold pulp sensibility test.
- Teeth with no periapical pathosis on radiographic examination.
Key exclusion criteria (12 listed)
- Allergy to any of the restorative materials (OptiBond Universal or Hi-Bond Universal).
- Patients currently undergoing orthodontic treatment with fixed appliances.
- Pregnant women or those planning pregnancy during the study period.
- Patients with systemic diseases that could interfere with dental treatment (e.g., uncontrolled diabetes, cardiovascular diseases).
- Use of analgesics or medications that could mask postoperative sensitivity.
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 |
|---|---|---|
| Hi-Bond Universal AdhesiveA bioactive glass adhesive containing mesoporous bioactive glass designed to promote dentin remineralization, manufactured by Mediclus, Korea. It releases calcium and phosphate ions to enhance dentin sealing and reduce hypersensitivity The adhesive will be applied after selective caries removal following a standardized protocol: Selective enamel etching with 37% phosphoric acid for 15 seconds. Application of HI Bond Universal adhesive with agitation for 20 seconds. Light curing for 20 seconds using a LED curing device. Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA). Occlusal adjustment, finishing, and polishing. | Device | Intervention - Hi-Bond Universal Adhesive |
| OptiBond Universal Adhesiveconventional universal adhesive designed for bonding composite restorations to enamel and dentin. The adhesive will be applied after selective caries removal following a standardized protocol: Selective enamel etching with 37% phosphoric acid for 15 seconds. Application of OptiBond Universal adhesive with agitation for 20 seconds. Light curing for 20 seconds using a LED curing device. Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA). Occlusal adjustment, finishing, and polishing. | Device | Optibond Universal adhesive |
Primary outcome
Clinical Performance - Functional Properties (Retention loss)
Time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
The clinical performance of the adhesive systems will be assessed based on the functional properties, specifically focusing on the retention of the composite Restoration Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials. Assessment Method: FDI Criteria Scores (1-5)
8 secondary outcomes
Clinical Performance - Functional Properties (fracture of the material)
Time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Approximal Anatomical Form
Time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Marginal Adaptation
Time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Clinical Performance - Biological Properties (Caries at Restoration Margins)
Time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Postoperative Hypersensitivity
Time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Adjacent Mucosa Condition
Time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Esthetic Properties - Staining (Surface and Margin)
Time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Remaining Dentin Bridge - Remineralization
Time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 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 25 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Caries
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
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.
Ahmed Hesham Samaha, PhD candidate Conservative Dep contact
Prof. Dr. Rasha Raafat Main Supervisor / Data Monitoring, professor conservative depar. 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 Hi-Bond Universal Adhesive and OptiBond Universal Adhesive 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 12 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 25 May 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 Ahmed Hesham Samaha, PhD candidate Conservative Dep ((+2) 01007484138, ahmed.hesham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance - Functional Properties (Retention loss) (time frame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)). 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 25 May 2025.