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36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions

Clinical Performance of a Micro-hybride Resin Based Composite in the Treatment of Cervical Caries Lesions: 36-month, Split-mouth, Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03722758
Enrollment
33
Registered
2018-10-29
Start date
2016-07-15
Completion date
2019-11-15
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root Caries

Keywords

micro hybrid resin composite, resin-modified glass ionomer, split-mouth randomized clinical trial

Brief summary

This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18,24 and 36 months according to the USPHS criteria.

Detailed description

The aim of the study was to comparatively assess the 36-month clinical performance of a micro hybrid resin composite and resin-modified glass ionomer cement in root caries lesions. Thirty-three patients with at least two root caries lesions participated in this study. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18, 24 and 36 months. The data were analyzed with Pearson's Chi-square, Cochran's Q, Friedman tests and Logistic Regression Analysis (p=0.05).

Interventions

DEVICESpectrum TPH3

tooth restoration with two different restorative materials

DEVICERiva LC

tooth restoration with two different restorative materials

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Root caries lesions (at least 1mm depth)

Exclusion criteria

* Complex medical history * Poor dental hygiene/infrequent practise of oral hygiene habits * Severe or chronic periodontitis * Extreme carious activity * Heavy bruxism * Very deep (closer than 0.5 mm to the pulp) or superficial lesions (shallower than 1mm) * Previously restored and abutment teeth for bridge or removable dental prostheses

Design outcomes

Primary

MeasureTime frameDescription
Marginal adaptation 0 for at least 90% restorations (marginal adaption score)24 monthsThe primary factor for determining the clinical performance of a restorative material is the marginal adaption score. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at least 90% survival rate after 18. The retention scored as 0 (restoration appears to adapt closely to the surface of the tooth with no crevice formation), 1 (an explorer caught lightly when run in both directions, and there was visible evidence of early crevice formation), 2 (an explorer got caught in both directions and penetrated a marginal crevice), 3 (the crevice had sufficient depth to expose the dentin, required replacement) or 4 (The restoration was fractured or lost). Clinical evaluation is performed to examine if the restorations are in place or fallen.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026