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

Not Applicable

Not yet recruiting

• Conditions: Deep Caries; Dental Caries
• Interventions: Other: Nanohybrid resin composite material; Other: Beautifil II LS

• Registration Number: NCT06497231
• Lead Sponsor: Cairo University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-11
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-27
• Study Start: 2024-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanohybrid resin composite	Nanohybrid resin composite material	Deep margin elevation and subsequent restoration will be done using nanohybrid resin composite
Bioactive Giomer Material	Beautifil II LS	Deep margin elevation and subsequent restoration will be done using bioactive giomer material

Primary Outcome Measures

Name	Time	Method
Post-operative sensitivity	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.

Secondary Outcome Measures

Name	Time	Method
Marginal adaptation	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.
Occurrence of caries	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.
Proximal Contact	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.
Plaque Index	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.
Gingival Index	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.
Interdental Pressure Index	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.
Papillary bleeding on probing Index	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.
Probing Depth	Baseline (1 week after intervention), 6 months, 12 months and 24 months
Radiographic examination	Baseline (1 week after intervention), 6 months, 12 months and 24 months