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

NCT06990945 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: CU-2025-05cu-fund-202505
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Caries

Keywords

Class II Carious Lesions; Dentin Remineralization; Dental Adhesives; Bioactive Glass; Restorative Dentistry; Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• 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)

  24 months (Baseline, 6 months, 12 months, 18 months, 24 months)

Secondary Outcomes (8)

• Clinical Performance - Functional Properties (fracture of the material)

  24 months (Baseline, 6 months, 12 months, 18 months, 24 months)

• Approximal Anatomical Form

  24 months (Baseline, 6 months, 12 months, 18 months, 24 months)

• Marginal Adaptation

  24 months (Baseline, 6 months, 12 months, 18 months, 24 months)

• Clinical Performance - Biological Properties (Caries at Restoration Margins)

  24 months (Baseline, 6 months, 12 months, 18 months, 24 months)

• Postoperative Hypersensitivity

  24 months (Baseline, 6 months, 12 months, 18 months, 24 months)

Study Arms (2)

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).

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.

Device: Hi-Bond Universal Adhesive

Interventions

Hi-Bond Universal Adhesive DEVICE

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.

Intervention - Hi-Bond Universal Adhesive

OptiBond Universal Adhesive DEVICE

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.

Optibond Universal adhesive

Eligibility Criteria

• Age: 22 Years - 42 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cairo University: lead
• providing support: Equipment and some consumables by Department of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Cairo University: collaborator

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

Dental Caries; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Central Study Contacts

Ahmed Hesham Samaha, PhD candidate Conservative Dep

CONTACT

(+2) 01007484138; ahmed.hesham@dentistry.cu.edu.eg

Prof. Dr. Rasha Raafat Main Supervisor / Data Monitoring, professor conservative depar.

CONTACT

rasha.raafat@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study employs a double-blinded design to minimize potential biases in outcome assessment and data analysis. The following masking strategy will be implemented: Participant Blinding: Participants will be unaware of the type of adhesive used during the restorative procedure. Both adhesives (Hi-Bond Universal and OptiBond Universal) will be applied using identical clinical procedures to maintain blinding. Outcomes Assessor Blinding: The outcomes assessors (N.S. and R.A.), responsible for evaluating clinical performance (fracture resistance, marginal adaptation, hypersensitivity) and radiographic assessments, will be blinded to the group assignment. They will not have access to information regarding the type of adhesive used for each patient. Operator (A.H.) Not Blinded: The operator performing the restorative procedures cannot be blinded due to the nature of the intervention. The operator will be aware of the adhesive used but will not participate in the outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate Conservative Department Cairo University

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

EG (1)