Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial

NCT ID: NCT05470959

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2021-12-20

Brief Summary

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compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.

Detailed Description

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patients were enrolled in the clinical trial. Each patient had two deep carious lesions, one on each side of the mouth. After selective caries removal, cavities were lined with bioactive ionic resin composite (Activa Bioactive Liner/Base) or resin-modified glass ionomer liner (Riva Light Cure RMGI). All cavities were then restored with nanofilled resin composite (Filtek Z350xt). All materials were placed according to the manufacturers' instructions. Clinical evaluation was accomplished using World Dental Federation (FDI) criteria at baseline and after 6 months, one year, one and half years, and two years.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ACTIVA bioactive

bioactive ionic resin composite

Group Type OTHER

ACTIVA bioactive

Intervention Type OTHER

bioactive ionic resin composite

Riva LC

Resin-modifed glass ionomer

Group Type OTHER

Riva LC

Intervention Type OTHER

resin-modified glass ionomer

Interventions

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ACTIVA bioactive

bioactive ionic resin composite

Intervention Type OTHER

Riva LC

resin-modified glass ionomer

Intervention Type OTHER

Other Intervention Names

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Riva light cure

Eligibility Criteria

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Inclusion Criteria

* presence of two deep carious lesions, one on each side of the mouth (ICDAS 5 or 6)
* vital teeth
* no sensitivity to teeth percussion
* no spontaneous pain
* no radiolucency in the periapical or furcation area of teeth
* complete and normal occlusion
* good oral hygiene

Exclusion Criteria

* poor oral hygiene
* severe or chronic periodontal problems
* periapical lesions
* heavy bruxism
* non-vital teeth
* visibly cracked teeth
* spontaneous dental pain
* sensitivity to teeth percussion
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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salah mahmoud, professor

Role: STUDY_DIRECTOR

faculty of dentistry, mansoura university

Locations

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Faculty of Dentistry

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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Ahmed B, Wafaie RA, Hamama HH, Mahmoud SH. 3-year randomized clinical trial to evaluate the performance of posterior composite restorations lined with ion-releasing materials. Sci Rep. 2024 Feb 28;14(1):4942. doi: 10.1038/s41598-024-55329-6.

Reference Type DERIVED
PMID: 38418863 (View on PubMed)

Other Identifiers

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M19091019

Identifier Type: -

Identifier Source: org_study_id

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