NCT07731308

Brief Summary

This randomized controlled clinical trial aims to compare the clinical performance of zirconia-reinforced glass ionomer and injectable giomer restorations in Class V carious lesions among controlled type II diabetic against non-diabetics. One hundred Class V restorations will be allocated equally into four parallel groups according to restorative material and diabetic status. Clinical performance will be evaluated at baseline, 6, 12, and 18 months using the modified United States Public Health Service (USPHS) criteria. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, secondary caries, and postoperative sensitivity.

Trial Health

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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jan 2027

Typical duration for not_applicable

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

July 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

July 21, 2026

Last Update Submit

July 24, 2026

Conditions

Class V Dental Caries, Type 2 Diabetes MellitusGiomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer

Outcome Measures

Primary Outcomes (1)

  • Restoration Retention

    Restoration retention assessed using the modified USPHS criteria

    Baseline, 6 months, 12 months, and 18 months

Secondary Outcomes (4)

  • Marginal adaptation

    Baseline, 6 months, 12 months, and 18 months

  • Marginal discoloration

    Baseline, 6 months, 12 months and 18 months

  • Secondary caries

    Baseline, 6 months, 12 months and 18 months.

  • Postoperative sensitivity

    Baseline, 6 months, 12 months and 18 months.

Study Arms (2)

Diabetic

EXPERIMENTAL
Other: ZirconomerOther: Beautifil Flow Plus X

Non-diabetic

EXPERIMENTAL
Other: ZirconomerOther: Beautifil Flow Plus X

Interventions

ZirconomerOTHER

Zirconia-reinforced glass ionomer restorative material (SHOFU)

DiabeticNon-diabetic
Beautifil Flow Plus XOTHER

Injectable giomer restorative material incorporating S-PRG technology (SHOFU)

DiabeticNon-diabetic

Eligibility Criteria

Age22 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or Female participants from 22 to 55 years
  • Controlled diabetic and non-diabetic patients consulting the outpatient clinic
  • Patients categorized as moderate or high caries risk
  • Patients willing to provide informed consent
  • Teeth with class V carious lesion classified according to the International Caries Detection and Assessment System (ICDAS II) as ICDAS code (4) or ICDAS code (5)
  • Teeth with normal pulp vitality testing; no signs of inflammation or spontaneous pain before treatment

You may not qualify if:

  • Patients with spontaneous or elicited pain from caries.
  • Systemic illnesses other than diabetes.
  • Severe bruxism/clenching.
  • Temporomandibular joint disorders.
  • Inability to return for recall visits/ Refusal to participate in the study.
  • Pregnancy.
  • heavy smoking.
  • Lack of compliance.
  • Teeth presenting with spontaneous or elicited pain
  • A lack of normal pulp vitality testing
  • Visible or clinical signs of pulpal/periapical inflammation before treatment.
  • Class V carious lesions that are not classified as ICDAS code (4) or ICDAS code (5).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Mohamed Ayman Hamdy Ayman

CONTACT

+201127669997mohamed.ayman@dentistry.cu.edu.eg

Study Design

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

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 28, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

July 28, 2026

Record last verified: 2026-07