Evaluation of Bioactive Giomer Material Versus Nanohybrid Resin Composite in Deep Marginal Elevation

November 24, 2024 updated by: Samir Ashraf Fayez Rostom, Cairo University

Clinical and Periodontal Evaluation of Deep Marginal Elevation for Proximal Carious Lesions Restored with Bioactive Giomer Versus Nanohybrid Resin Composite: Two Years Randomized Trial

This study will be conducted to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer compared to nanohybrid resin composite restoration in deep subgingival proximal cavities extending below the CEJ over a period of 24 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and rationale:

Recent development in different adhesive techniques and materials has led clinicians to attempt restoring teeth with subgingival defects below the cemento-enamel junction (CEJ). Deep marginal elevation (DME) or cervical margin relocation (CMR) is a procedure that involves raising the proximal margin of the tooth defect with direct composite to promote isolation and restoration using direct, semi-direct or indirect techniques. A high level of knowledge and clinical expertise are necessary to perform such procedure in a predictable way in addition to meticulous attention to the supracrestal tissue attachment or the biological width which consists of junctional epithelium and supracrestal connective tissue attachment.

Research question:

In young and middle-aged patients having deep subgingival proximal cavities extending below CEJ, will the bioactive Giomer show similar clinical, radiographic and periodontal performance compared to nanohybrid resin composite over 2 years follow up?

Statement of the problem:

Carious lesions that extend in subgingival areas present several difficulties for the clinician. Firstly, applying rubber dam in deep cavities and the process of trying to obtain a gingival margin free of caries are very challenging. Secondly, there is a great biological concern to master the subgingival restoration reaction with the adjacent periodontal tissues. Obtaining a healthy periodontal status after treatment has long been a challenging endeavor in the restorative dentistry. Lastly, bonding to deep, carious, and moist dentin surrounded by cementum is inherently suboptimal. To overcome these problems, many techniques and materials were presented to deal with such complex restorative situations. Because of their chemical adherence to the tooth structure, fluoride release and hydrophilicity glass ionomer cements are a reliable option for cementum margins and deep dentin bonding. Marginal defects appearing at the cervical margins due to the solubility property of the material was the main problem the dentist faced in these situations. On the other hand, resin composites are a dependable choice in these circumstances due to their higher mechanical qualities and the way their composition has improved, however, poor material bonding in subgingival margins along with high polymerization stresses associated with them have made it a very complicated procedure.

Rationale for conducting the research:

The use of fluoride releasing dental materials in deep carious lesions was explored before to remineralize the surrounding tooth structure and allow for a more durable restoration with increased resistance to the development of secondary caries. The introduction of Giomers, which combines resin composite and glass ionomer modes of action by Shofu, (Inc.) in the early 2000s was due to the revolutionary surface prereacted glass-ionomer (S-PRG) filler technology that allowed for improved resistance to recurrent caries development. Therefore, this type of bioactive system, adhesive and restoring materials, was claimed to enhance the outcome of deep subgingival restoration clinically, periodontally, and radiographically.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Young and middle aged patients (20-50)
  2. Good or moderate oral hygiene (plaque index 0 or 1 )
  3. Patient approval
  4. Absence of parafunctional habits and/or bruxism

Exclusion Criteria:

  1. Patients with known allergic or adverse reaction to the tested materials.
  2. Systematic disease that may affect participation.
  3. Xerostomic patients.
  4. Patients with active periodontal disease.
  5. Heavy smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bioactive Giomer Material
Deep margin elevation and subsequent restoration will be done using bioactive giomer material
Other: Beautifil II LS
Beautifil II LS is a low shrinkage bioactive giomer resin composite.
Active Comparator: Nanohybrid resin composite
Deep margin elevation and subsequent restoration will be done using nanohybrid resin composite
Other: Nanohybrid resin composite material
Nanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative sensitivity
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Restorations will be assessed by testing of irritability of the pulpal nerve on cold, e.g., with dry ice or cold spray, in comparison to the reaction of a contralateral, sound, and unrestored tooth.
Baseline (1 week after intervention), 6 months, 12 months and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal adaptation
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Baseline (1 week after intervention), 6 months, 12 months and 24 months
Occurrence of caries
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Baseline (1 week after intervention), 6 months, 12 months and 24 months
Proximal Contact
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Method of restorations assessment will be tactile using unwaxed dental floss to evaluate proximal contact tightness. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Baseline (1 week after intervention), 6 months, 12 months and 24 months
Probing Depth
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Baseline (1 week after intervention), 6 months, 12 months and 24 months
Radiographic examination
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Baseline (1 week after intervention), 6 months, 12 months and 24 months
Plaque Index
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months

The Plaque Index (PI) is a clinical tool used by dentists to assess the presence and severity of dental plaque accumulation on the teeth. It is scored on a scale of 0 to 3:

0: No plaque present.

  1. A thin film of plaque visible only with a probe or at the gingival margin.
  2. Moderate plaque accumulation visible to the naked eye.
  3. Heavy plaque accumulation visible on the tooth surface.
Baseline (1 week after intervention), 6 months, 12 months and 24 months
Gingival Index
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months

The Gingival Index (GI) is a clinical tool used to assess the health of the gums by evaluating the presence and severity of gingival inflammation.

Gingival Index Scoring (0 to 3):

The Gingival Index evaluates the gingiva (gums) at four sites per tooth (mesial, distal, buccal, and lingual). Each site is scored on a scale from 0 to 3:

0: Normal gingiva - No inflammation, healthy gums.

  1. Mild inflammation - Slight redness, no bleeding on probing, no swelling.
  2. Moderate inflammation - Redness, slight swelling, and bleeding on probing.
  3. Severe inflammation - Redness, swelling, and bleeding even without probing; possibly ulcerated or visibly infected gums.
Baseline (1 week after intervention), 6 months, 12 months and 24 months
Interdental Pressure Index
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months

Apical pressure of a horizontally placed periodontal probe is applied to evaluate periodontal tissue response. It is negative when gingival tissues are firm, bleeding-free, and slightly ischemic by the stimulation; otherwise it is positive.

It follows a negative or positive binary score.
Baseline (1 week after intervention), 6 months, 12 months and 24 months
Papillary bleeding on probing Index
Time Frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months

The Papillary Bleeding on Probing (PBI) Index is a clinical tool used to assess the presence of bleeding from the papillary gingiva (the area of gum tissue between the teeth) when a periodontal probe is gently inserted. This index helps evaluate the level of gingival inflammation and is commonly used in diagnosing gingivitis or early stages of periodontal disease.

Scoring System: The PBI uses a simple scale to score bleeding, often as follows:

0: No bleeding on probing - Healthy gingiva with no signs of inflammation.

  1. Bleeding on probing - A slight amount of bleeding from the papillary gingiva occurs within 15 seconds after probing.
  2. Bleeding on probing with immediate response - Bleeding is visible immediately after probing, indicating more significant inflammation.
  3. Spontaneous bleeding - Bleeding occurs without probing, indicating advanced gingival inflammation or active gum disease.
Baseline (1 week after intervention), 6 months, 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Giomer in DME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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