Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions

NCT05981625 | Not Yet Recruiting

• 1 other identifier: 14422022559057
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is test the dentin hypersenstivity using Giomer based Varnish versus Bioactive glass air polishing system in patients with non-cervical lesions.

Conditions

Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG

Outcome Measures

Primary Outcomes (1)

• Pain due to dentin hypersenstivity

  Dentin hypersensitivity was assessed by three different stimuli (evaporative , thermal and tactile) to simulate the different situations in which Dentin hypersensitivity arises. Using the Visual Analog scale (VAS), the participant marks the pain intensity on a graduated 10 cm straight line (0 = no pain, 10 = extreme pain)

  baseline preoperative, immediate postoperative, 1 , 6 and 12-months' time

Secondary Outcomes (1)

• Color change (Tooth discoloration)

  Baseline preoperative, immediate postoperative, 1,6 and 12-months time

Study Arms (2)

Giomer varnish containing surface pre-reacted glass fillers

EXPERIMENTAL

Giomer-based varnish is a light-curable varnish/desensitizer. The surface pre-reacted glass (S-PRG) filler is a bioactive trilaminar structure with a multifunctional glass core embedded in resin matrix. It can release and recharge fluoride ions. When it becomes in contact with the oral fluids, it starts to bind to the collagen fiber and release six different types of ions like fluoride, calcium, phosphate that help in the formation of apatite crystals and seal the open dentinal tubules with a long-lasting effect Brand name: S\_PRG (Shofu-Japan)

Other: Giomer varnish containing surface pre-reacted glass fillers

Bioactive Glass Air Polishing

ACTIVE COMPARATOR

Bioactive glass powder delivered by standalone air polishing system, is a bioactive material that reacts with saliva to deposit Hydroxycarbonate Apatite crystals (HCA), which is very strong and resilient. The continuous release of calcium ions promotes constant protection and long lasting seal of the tubules. Using the air polishing delivery system helps to provide a huge amount of calcium and phosphate particles at the exposed surface of the tooth. Moreover, the air pressure aids in pushing these particles inside the dentinal tubules to a considerable depth. Air polishing using such powder provides a bifunctional advantage of occluding the dentinal tubules. However, there is limited clinical trials testing the efficacy of the bioactive glass powder air polishing system in minimizing the dentin hypersensitivity

Other: Giomer varnish containing surface pre-reacted glass fillers

Interventions

Giomer varnish containing surface pre-reacted glass fillers OTHER

Giomer varnish (PRG barrier coat) will used as the intervention agent in this study. , Giomer is considered as a hybrid material between the resins modified glass ionomers and the composite resins. It is composed of 45% Sio2, 24.5% Na2O, 24.5% Ca O and 6% P2O5 . The presence of sodium is very important due to its bioactivity while the phosphate is responsible for the degree of degradation and formation of apatite. Based on this composition, giomer has several clinical applications in implant, periodontics, bone generation, pulp capping, Root canal treatment, as restorative materials, in air abrasion, enamel remineralization and finally dentin hypersensitivity

Bioactive Glass Air Polishing; Giomer varnish containing surface pre-reacted glass fillers

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants complaining from dentin hypersensitivity.
• Middle aged patients.
• Good oral hygiene.

You may not qualify if:

• Pregnant women.
• Patients with allergy to any material used in this study.
• Smoking patients will affect the oral hygiene and periodontal health.
• Patients taking anti-inflammatory drugs that will affect the perception of hypersensitivity.
• Systemically compromised patients.
• Smokers.
• Patients received desensitization treatment in the last 6 months

Sponsors & Collaborators

• Cairo University: lead

Related Publications (4)

• Ravishankar P, Viswanath V, Archana D, Keerthi V, Dhanapal S, Lavanya Priya KP. The effect of three desensitizing agents on dentin hypersensitivity: A randomized, split-mouth clinical trial. Indian J Dent Res. 2018 Jan-Feb;29(1):51-55. doi: 10.4103/ijdr.IJDR_458_17.

  PMID: 29442087 BACKGROUND

• West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.

  PMID: 24993261 BACKGROUND

• Favaro Zeola L, Soares PV, Cunha-Cruz J. Prevalence of dentin hypersensitivity: Systematic review and meta-analysis. J Dent. 2019 Feb;81:1-6. doi: 10.1016/j.jdent.2018.12.015. Epub 2019 Jan 11.

  PMID: 30639724 BACKGROUND

• Freitas Sda S, Sousa LL, Moita Neto JM, Mendes RF, Prado RR. Dentin hypersensitivity treatment of non-carious cervical lesions - a single-blind, split-mouth study. Braz Oral Res. 2015;29:45. doi: 10.1590/1807-3107BOR-2015.vol29.0045. Epub 2015 Mar 10.

  PMID: 25760065 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

omnia Samy Garouda, master's

CONTACT

00201273573591; omnia.mostafa@dentistry.cu.edu.eg

Asmaa Yaseen, Professor

CONTACT

Asmaa.yaseen@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: April 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: March 1, 2026
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share