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

NCT03722758 | Unknown

• 1 other identifier: 2016/03-23 (KA-16003)
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Root Caries

Keywords

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

Outcome Measures

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.

  24 months

Study Arms (2)

Spectrum TPH3, tooth restoration

ACTIVE COMPARATOR

Restoration with micro hybrid resin composite

Device: Spectrum TPH3; Device: Riva LC

Riva LC, restorative material

ACTIVE COMPARATOR

Restoration with resin-modified glass ionomer cement

Device: Spectrum TPH3; Device: Riva LC

Interventions

Spectrum TPH3 DEVICE

tooth restoration with two different restorative materials

Also known as: resin composite

Riva LC, restorative material; Spectrum TPH3, tooth restoration

Riva LC DEVICE

tooth restoration with two different restorative materials

Also known as: RMGİC

Riva LC, restorative material; Spectrum TPH3, tooth restoration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Root caries lesions (at least 1mm depth)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Uzay Koc-Vural

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 29, 2018
• Study Start: July 15, 2016
• Primary Completion: July 15, 2018
• Study Completion: November 15, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07