The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities (Randomized)

NCT06924047 | Not Yet Recruiting

• 1 other identifier: Restoring Deep Occlusal Cavity
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Higher mechanical properties are needed to restore structurally compromised posterior teeth, short fiber reinforced resin composite and injectable bioactive resin composites provide superior properties to flowable composites that were traditionally used to improve adaptation in deep cavities below the packable resin composite restorations. Thus, this study was designed to assess the clinical outcome of high strength dentine substitute materials.

Conditions

Class I Cavities in High Caries Risk; Class I Composite Restorations; Randomized Clinical Trial; Occlusal Caries; Fiber Reinforced Composite; Injectable Composite; Composite Restoration; Composite Resins

Keywords

occlusal caries

Outcome Measures

Primary Outcomes (1)

• Fracture

  1. Clinically excellent/very good (sufficient): Restoration is completely present without deficiencies detectable after air drying. 2. Clinically good (sufficient): Restoration is completely present with minor deficiencies detectable after air drying 3. Clinically satisfactory (sufficient): Restoration is present with deficiencies detectable without air drying 4. Clinically unsatisfactory (partially insufficient): Localized but severe deficiencies regarding fracture and retention 5. Clinically poor (entirely insufficient): Generalized severe deficiencies

  T1: 1 week T2: 6months T3: 12 months

Secondary Outcomes (2)

• Recurrent caries

  T1: 1 week T2: 6months T3: 12 months

• Post operative sensitivity

  T1: 1 week T2: 6months T3: 12 months

Study Arms (2)

Bioactive injectable composite

ACTIVE COMPARATOR

bioactive injectable composite placed as a dentine substitute

Other: Beautifil Flow Plus X

Short fiber reinforced composite

ACTIVE COMPARATOR

Short fiber reinforced composite added as a dentine substitute

Other: EverX Flow

Interventions

Beautifil Flow Plus X OTHER

Shofu's Beautifil Flow Plus X F00 a advanced bioactive injectable composite

Bioactive injectable composite

EverX Flow OTHER

Short fiber reinforced composite

Short fiber reinforced composite

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged (20-50)
• Medically free
• Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus))
• Patients accepting to participate in the study.
• Teeth of normal appearance and morphology
• Maxillary and mandibular molar teeth with deep class Ⅰ carious lesions extending into the inner third of dentin.

You may not qualify if:

• Patients \<20 and \>50.
• Teeth with proximal lesions.
• Patients with bad oral hygiene (Plaque index \>2).
• Systematic disease that may interfere with the study.
• Patients with xerostomia.
• Presence of any abnormal occlusal habits (bruxism, nail biting, clenching).
• Patients undergoing or will start orthodontic treatment.
• Pregnancy.
• Teeth with signs or symptoms of irreversible pulpitis.
• Non-vital, fractured or cracked teeth.
• Teeth with secondary caries.
• Periodontally compromised teeth.

Sponsors & Collaborators

• Dalia Sameh Fawzi: lead

Related Publications (14)

• Yao Y, Luo A, Hao Y. Selective versus stepwise removal of deep carious lesions: A meta-analysis of randomized controlled trials. J Dent Sci. 2023 Jan;18(1):17-26. doi: 10.1016/j.jds.2022.07.021. Epub 2022 Aug 21.

  PMID: 36643250 BACKGROUND

• Schwendicke F, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona AF, Innes NP. Managing Carious Lesions: Consensus Recommendations on Carious Tissue Removal. Adv Dent Res. 2016 May;28(2):58-67. doi: 10.1177/0022034516639271.

  PMID: 27099358 BACKGROUND

• Rusnac ME, Gasparik C, Irimie AI, Grecu AG, Mesaros AS, Dudea D. Giomers in dentistry - at the boundary between dental composites and glass-ionomers. Med Pharm Rep. 2019 Apr;92(2):123-128. doi: 10.15386/mpr-1169. Epub 2019 Apr 25.

  PMID: 31086838 BACKGROUND

• Reis A, Carrilho M, Breschi L, Loguercio AD. Overview of clinical alternatives to minimize the degradation of the resin-dentin bonds. Oper Dent. 2013 Jul-Aug;38(4):E1-E25. doi: 10.2341/12-258-LIT. Epub 2013 Mar 25.

  PMID: 23527523 BACKGROUND

• Qin D, Hua F, John MT. GLOSSARY FOR DENTAL PATIENT-CENTERED OUTCOMES. J Evid Based Dent Pract. 2024 Jan;24(1S):101951. doi: 10.1016/j.jebdp.2023.101951. Epub 2023 Nov 5.

  PMID: 38401954 BACKGROUND

• Ozer F, Patel R, Yip J, Yakymiv O, Saleh N, Blatz MB. Five-year clinical performance of two fluoride-releasing giomer resin materials in occlusal restorations. J Esthet Restor Dent. 2022 Dec;34(8):1213-1220. doi: 10.1111/jerd.12948. Epub 2022 Aug 7.

  PMID: 35934807 BACKGROUND

• Maillet C, Decup F, Dantony E, Iwaz J, Chevalier C, Gueyffier F, Maucort-Boulch D, Grosgogeat B, Le Clerc J. Selected and simplified FDI criteria for assessment of restorations. J Dent. 2022 Jul;122:104109. doi: 10.1016/j.jdent.2022.104109. Epub 2022 Mar 26.

  PMID: 35346772 BACKGROUND

• Ikeda I, Otsuki M, Sadr A, Nomura T, Kishikawa R, Tagami J. Effect of filler content of flowable composites on resin-cavity interface. Dent Mater J. 2009 Nov;28(6):679-85. doi: 10.4012/dmj.28.679.

  PMID: 20019418 BACKGROUND

• Hoefler V, Nagaoka H, Miller CS. Long-term survival and vitality outcomes of permanent teeth following deep caries treatment with step-wise and partial-caries-removal: A Systematic Review. J Dent. 2016 Nov;54:25-32. doi: 10.1016/j.jdent.2016.09.009. Epub 2016 Sep 21.

  PMID: 27664467 BACKGROUND

• Elderiny HM, Khallaf YS, Akah MM, Hassanein OE. Clinical Evaluation of Bioactive Injectable Resin Composite vs Conventional Nanohybrid Composite in Posterior Restorations: An 18-Month Randomized Controlled Clinical Trial. J Contemp Dent Pract. 2024 Aug 1;25(8):794-802. doi: 10.5005/jp-journals-10024-3737.

  PMID: 39653674 BACKGROUND

• ElAziz RHA, ElAziz SAA, ElAziz PMA, Frater M, Vallittu PK, Lassila L, Garoushi S. Clinical evaluation of posterior flowable short fiber-reinforced composite restorations without proximal surface coverage. Odontology. 2024 Oct;112(4):1274-1283. doi: 10.1007/s10266-024-00905-5. Epub 2024 Feb 23.

  PMID: 38393515 BACKGROUND

• European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.

  PMID: 30664240 BACKGROUND

• Bijelic-Donova J, Myyrylainen T, Karsila V, Vallittu PK, Tanner J. Direct Short-Fiber Reinforced Composite Resin Restorations and Glass-Ceramic Endocrowns in Endodontically Treated Molars: A 4 -Year Clinical Study. Eur J Prosthodont Restor Dent. 2022 Nov 30;30(4):284-295. doi: 10.1922/EJPRD_2333Bijelic-Donova12.

  PMID: 35438265 BACKGROUND

• Battancs E, Sary T, Molnar J, Braunitzer G, Skolnikovics M, Schindler A, Szabo P B, Garoushi S, Frater M. Fracture Resistance and Microleakage around Direct Restorations in High C-Factor Cavities. Polymers (Basel). 2022 Aug 25;14(17):3463. doi: 10.3390/polym14173463.

  PMID: 36080538 BACKGROUND

Central Study Contacts

Dalia SA Fawzi, BDS

CONTACT

+201147984047; dr.daliasameh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 11, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04