Clinical Evaluation of Bioactive Resin Composites Versus Caries Control Technique in Management of Class I Carious Cavities in High Caries Risk Patients: a Randomized Clinical Trial

The aim of the study is to clinically evaluate the performance of S-PRG based & Alkasite based resin composite restorations versus conventional resin composite restorations after caries control in Class I carious cavities in posterior molar teeth over 1 year follow up.

Study Overview

• Status: Not yet recruiting
• Conditions: High Caries Risk Patients
• Intervention / Treatment: Other: "SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan).; Other: Alkasite based restoration : Cention N; Other: provisional Resin modified glass ionomer followed by Nanohybrid composite

Detailed Description

Traditionally, less conservative methods have been employed to treat tooth decay, which implied more loss of healthy dental tissue in order to increase the mechanical retention of the restorative material. Minimally invasive treatments have been proposed as an alternative therapy, which has evolved in with the development of new biomaterials.Bioactive restorative materials, as advocated by the FDI World Dental Federation, can promote mineralization/hard tissue creation, bacterial infection control, inflammation prevention, and tissue regeneration. In simpler terms : One efficient way to achieve bioactive functionalities in dental materials is to use particles that have the ability to release particular component.The development of "Giomer" based resin composites, which have the added benefit of prolonged fluoride and other ions release as well as rechargeability, is one of the key technological advances in resin composites to promote its usage as a bioactive material.In fact, Giomers with S-PRG fillers can release more fluoride than that of other fluoride-releasing restorations.Acid neutralization capacity by S-PRG fillers, one of many bioactive functions, is in which the pH of the surrounding environment became slightly alkaline upon contact with water or acidic solutions, exhibiting a modulation impact on acidic circumstances. Owing to the release of multiple ions, such modulation effect might be brought about by the release of Sr, B, Na, and F ions clarifying an acid buffering mechanism.A modification of GIC is Cention-N, which was introduced as a new resin-based material containing alkacid fillers, such as fluoride, calcium, and hydroxide ions, to neutralize acids. Owing to being tooth-colored, inexpensive, and having good flexural strength, It's considered as a subcategory of the composite material class.With properties similar to those of GICs and RBCs, Cention-N releases calcium, hydroxyl, and fluoride ions to prevent tooth demineralization. The presence of hydroxide ions on the material's surface may be crucial in neutralizing the acids that were produced by cariogenic bacteria Additionally, the filler's release of calcium and fluoride ions contributes in remineralization process.In Conclusion; S-PRG & Alkasite based composite restorative materials are able to release ions that contribute to tooth mineralization as well as have a modulation effect on the acidic conditions produced by oral cariogenic microorganisms.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara M Khalil, Bachelor Degree(BDS); Phone Number: +20-2(01008927568); Email: sara-mansour@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient inclusion:

  1. Adult Patients (Male or Females) aging ≥21-50 years.
  2. Patients with high level of caries risk.
  3. Patients with good likelihood of recall availability.

Tooth inclusion:

1- Permanent posterior molar teeth with primary simple occlusal Class I carious lesions (ICDAS 3 or 4 scores) 3- 2- Vital, periodontally sound and with positive reaction to cold stimulus. 4- 3-Well-formed and fully erupted in normal functional occlusion with natural antagonist and adjacent teeth

Exclusion Criteria:

- Participants with general/systemic illness. 2- Pregnant or lactating females. 3- Concomitant participation in another research study. 4- Inability to comply with study procedures. 5- Heavy bruxism habits. 6- Last experience with allergic reactions against any components of the used materials.

7- Patients receiving orthodontic treatment.

Tooth exclusion:

1. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
2. Non-vital teeth, Fractured or cracked teeth.
3. Secondary carious lesions.
4. Hypocalcified or hypoplastic teeth.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "SPRG-based" Resin Composite. (BEAUTIFIL II, Shofu Inc. Kyoto, Japan).; A fluoride releasing, highly aesthetic dental material for all classes of restorations with S-PRG (Surface Pre-reacted Glass Ionomer) technology in regards to it's ability to recharge fluoride and appropriate for patients with a high caries index.	Other: "SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan).; A fluoride releasing, highly aesthetic dental material that is S-PRG (Surface Pre-reacted Glass Ionomer) based , has the ability to recharge fluoride and appropriate for patients with a high caries index.
Experimental: "Alkasite-based" restoration. (Cention N); Cention N offers tooth-coloured esthetics together with high flexural strength. The new filling material belongs to the materials group of Alkasites. The patented alkaline filler increases the release of hydroxide ions to regulate the pH value during acid attacks. As a result, demineralization can be prevented. Moreover, the release of large numbers of fluoride and calcium ions forms a sound basis for the remineralization of dental enamel. The initiator system enables good chemical self-curing.	Other: Alkasite based restoration : Cention N; Cention N offers tooth-coloured esthetics together with high flexural strength. The new filling material belongs to the materials group of Alkasites. The patented alkaline filler increases the release of hydroxide ions to regulate the pH value during acid attacks. As a result, demineralization can be prevented. Moreover, the release of large numbers of fluoride and calcium ions forms a sound basis for the remineralization of dental enamel. The initiator system enables good chemical self-curing.
Active Comparator: Provisional RMGI(Fuji IX EXTRA),followed by nanohybrid resin composite(Neo Spectra® ST LV, Dentsply); Traditional caries control technique by provisional Resin Modified Glass ionomer for 3 months period and then followed by removal and application of conventional nano hybrid composites.	Other: provisional Resin modified glass ionomer followed by Nanohybrid composite; GC Fuji IX GP® EXTRA is the fastest setting glass ionomer on the market.The faster final set saves valuable chair time which provides improved stability against water, an important feature in challenging oral environments. This product contains a next generation glass filler which elicits higher translucency, fluoride release, reactivity and a faster setting time. Then followed by Conventional Nano hybrid composite restoration(Neo Spectra® ST LV, Dentsply Sirona) which is nano-ceramic, light-cured, radiopaque, universal composite with novel SphereTEC filler technology.; Other Names: Traditional Caries Control Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative (hypersensitivity) and tooth vitality.	Revised FDI Criteria for Biological properties and by scoring: clinically very good; clinically good; clinically sufficient; clinically unsatisfactory; clinically poor	at baseline, 3 months, 6 months and 12 months.
Caries at restoration margin (CAR).	Revised FDI Criteria for Biological properties and by scoring: clinically very good; clinically good; clinically sufficient; clinically unsatisfactory; clinically poor	at baseline,3 months, 6 months and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost effectiveness	A. Cost of single restoration at baseline (for both groups) (Mean, ±SD). B. Average cost per restoration after1 year (Mean, ±SD).; - (for intervention group in case of adverse effects) (Mean, ±SD).; - (for control group: cost of the replacement with final restoration) in addition to the cost of adverse effects (Mean, ±SD).	at baseline, 3 months, 6 months and 12 months.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: high caries risk patients
• Other Study ID Numbers: 14422023456853

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