CClinicalTrials.gg
Status unknownNCT03722758Updated Jul 15, 2019

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

An interventional study of Spectrum TPH3 and Riva LC in Root Caries, sponsored by Hacettepe University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-15.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Root Caries

Browse trials for

Keywords

  • micro hybrid resin composite
  • resin-modified glass ionomer
  • split-mouth randomized clinical trial
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Root caries lesions (at least 1mm depth)

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Active comparator
    Spectrum TPH3, tooth restoration

    Restoration with micro hybrid resin composite

    Device: Spectrum TPH3 · Device: Riva LC

  • Active comparator
    Riva LC, restorative material

    Restoration with resin-modified glass ionomer cement

    Device: Spectrum TPH3 · Device: Riva LC

Interventions

  • DeviceSpectrum TPH3

    tooth restoration with two different restorative materials

    Also known as: resin composite

  • DeviceRiva LC

    tooth restoration with two different restorative materials

    Also known as: RMGİC

05

What researchers measure

Primary outcomes

  1. Marginal adaptation 0 for at least 90% restorations (marginal adaption score)

    The 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.

    Time frame: 24 months

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03722758
Lead sponsor
Hacettepe University
Responsible party
Uzay Koc (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Oct 29, 2018
Start date
Jul 15, 2016
Primary completion
Jul 15, 2018
Completion
Nov 15, 2019 (estimated)
Last update
Jul 15, 2019

Study contacts

Uzay Koc-Vural
principal investigator · Hacettepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion