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

NCT06797843 | Not Yet Recruiting DMC

• 1 other identifier: 14422023456853
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

High Caries Risk Patients

Keywords

high caries risk patients

Outcome Measures

Primary Outcomes (2)

• Postoperative (hypersensitivity) and tooth vitality.

  Revised FDI Criteria for Biological properties and by scoring: 1. clinically very good 2. clinically good 3. clinically sufficient 4. clinically unsatisfactory 5. 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: 1. clinically very good 2. clinically good 3. clinically sufficient 4. clinically unsatisfactory 5. clinically poor

  at baseline,3 months, 6 months and 12 months.

Secondary Outcomes (1)

• Cost effectiveness

  at baseline, 3 months, 6 months and 12 months.

Study Arms (3)

"SPRG-based" Resin Composite. (BEAUTIFIL II, Shofu Inc. Kyoto, Japan).

EXPERIMENTAL

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).

"Alkasite-based" restoration. (Cention N)

EXPERIMENTAL

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.

Provisional RMGI(Fuji IX EXTRA),followed by nanohybrid resin composite(Neo Spectra® ST LV, Dentsply)

ACTIVE COMPARATOR

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

Interventions

"SPRG-based" Resin Composite : (BEAUTIFIL II, Shofu Inc. Kyoto, Japan). OTHER

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.

"SPRG-based" Resin Composite. (BEAUTIFIL II, Shofu Inc. Kyoto, Japan).

Alkasite based restoration : Cention N OTHER

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.

provisional Resin modified glass ionomer followed by Nanohybrid composite OTHER

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.

Also known as: Traditional Caries Control Technique

Provisional RMGI(Fuji IX EXTRA),followed by nanohybrid resin composite(Neo Spectra® ST LV, Dentsply)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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.
• Patients receiving orthodontic treatment.
• Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
• Non-vital teeth, Fractured or cracked teeth.
• Secondary carious lesions.
• Hypocalcified or hypoplastic teeth.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Sara M Khalil, Bachelor Degree(BDS)

CONTACT

+20-2(01008927568); sara-mansour@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sara Mansour Khalil

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 29, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03