NCT07407855

Brief Summary

Diabetes mellitus is associated with structural and biochemical alterations in dentin that may negatively affect the clinical performance and longevity of adhesive dental restorations, particularly in cervical carious lesions. Giomer-based composite resins, containing pre-reacted glass ionomer fillers, release fluoride and other beneficial ions that may enhance remineralization and reduce the risk of secondary caries. This prospective, parallel-group, non-randomized clinical trial aims to evaluate the clinical performance of Giomer-based composite restorations in Class V carious lesions in controlled diabetic and non-diabetic patients. Restorations will be assessed using Modified USPHS criteria at baseline, 6, 12, and 18 months, with retention as the primary outcome and marginal adaptation, secondary caries, marginal discoloration, and post-operative sensitivity as secondary outcomes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
24mo left

Started Aug 2026

Typical duration for not_applicable diabetes-mellitus

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

January 25, 2026

Last Update Submit

February 10, 2026

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Restoration Retention Score Assessed Using Modified USPHS Criteria

    Retention of Class V Giomer-based composite restorations will be evaluated using Modified United States Public Health Service (USPHS) criteria. Each restoration will be assigned an ordinal score (Alpha, Bravo, Charlie) based on the presence or loss of restoration. Data will be reported as distribution of USPHS scores and frequency of restoration loss over time.

    Baseline, 6 months, 12 months, and 18 months

Secondary Outcomes (4)

  • Marginal Adaptation Score Assessed Using Modified USPHS Criteria

    Baseline, 6 months, 12 months, and 18 months

  • Secondary Caries Score Assessed Using Modified USPHS Criteria

    Baseline, 6 months, 12 months, 18 months

  • Marginal Discoloration Score Assessed Using Modified USPHS Criteria

    Baseline, 6 months, 12 months, 18 months

  • Post-Operative Sensitivity Score Assessed Using Modified USPHS Criteria

    Baseline, 6 months, 12 months, 18 months

Study Arms (2)

Diabetic Patients

EXPERIMENTAL

Controlled diabetic patients with Class V carious lesions restored using Giomer-based composite resin

Device: Giomer-based composite restoration

Non-Diabetic Patients

ACTIVE COMPARATOR

Non-diabetic patients with Class V carious lesions restored using the same Giomer-based composite and adhesive protocol.

Device: Giomer-based composite restoration

Interventions

Giomer-based composite restorationDEVICE

Giomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA).

Diabetic PatientsNon-Diabetic Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with Class V carious lesions (ICDAS scores 3 or 4).
  • Controlled diabetic patients diagnosed with diabetes mellitus (for diabetic group).
  • Non-diabetic patients with no systemic diseases (for control group).
  • Teeth indicated for Class V composite restoration.

You may not qualify if:

  • Uncontrolled diabetes mellitus.
  • Patients with other systemic diseases affecting oral health.
  • Teeth with pulpal involvement or requiring endodontic treatment.
  • Patients with parafunctional habits. Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Radwa Wael Ellahouny

CONTACT

01274268817radwa.wael@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Assistant

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 12, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

February 12, 2026

Record last verified: 2026-02