One Year Clinical Performance of Self Adhesive Giomer Containing Flowable Composite in Restoring Class V Cavities

NCT04944485 | Unknown

• 1 other identifier: 14422019423506
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial will be conducted to compare the clinical performance of self adhesive giomer containing flowable composite and putty nanohybrid resin composite in class V cavities over one year follow-up

Conditions

Class V Dental Caries; Composite Resin and Self Adhesive Flowable Composite

Outcome Measures

Primary Outcomes (1)

• Assessing change in marginal discoloration between time points 3, 6 ,12 months

  Visual inspection with mirror Alpha :There is no visual evidence of any marginal discoloration at the junction of the restoration and the adjacent tooth structure . Bravo :There is visual evidence of shallow marginal discoloration. Charlie : There is visual evidence of deep marginal discoloration toward a pulpal direction.

  3,6,12 months

Secondary Outcomes (1)

• Assessing change in modified USPHS criteria between time points 3, 6 ,12 months

  3,6,12 months

Study Arms (2)

class V cavities treated with putty nanohybrid resin composite

ACTIVE COMPARATOR

Selective enamel etching will be done and a universal adhesive (Prime\&Bond universal™ ,Dentsply)will be applied to both enamel and dentin. After gentle dryness and solvent evaporation the bonding agent will be cured for 20 seconds. Composite (Neo Spectra™ST, Dentsply, Sirona, USA) will be placed incrementally and light cured for 20 seconds

Other: (Neo Spectra™ ST, Dentsply, Sirona, USA)

class V cavities treated with Self adhesive giomer containing nanohybrid flowable composite

EXPERIMENTAL

Cleaning and gentle air blowing of the preparation. Then applying FIT SA F03 (Low Flow), SHOFU, USA. Spread in a thin layer (≤0.5mm) on the prepared surface with needle tip, microbrush and gently air-blow leave for 20 seconds then light cure for 5 seconds. Then,apply additional increments (≤2mm) of FIT SA and light cure each increment for 10 seconds then finish and polish

Other: (FIT SA F03, SHOFU, USA)

Interventions

(FIT SA F03, SHOFU, USA) OTHER

Self adhesive giomer containing nanohybrid flowable composite

class V cavities treated with Self adhesive giomer containing nanohybrid flowable composite

(Neo Spectra™ ST, Dentsply, Sirona, USA) OTHER

Conventional technique using putty nanohybrid resin composite

class V cavities treated with putty nanohybrid resin composite

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with carious anterior or posterior buccal class V lesions.
• No signs of irreversible pulpitis (vital teeth)
• Young adult males or females.
• Acceptable oral hygiene.
• Co-operative patients approving to participate in the study

You may not qualify if:

• Patients with a compromised medical history.
• Severe or active periodontal disease
• Systemic diseases or severe medical complications (disabilities).
• Lack of compliance
• Extensive carious lesion that is in risk of pulp exposure.
• Rampant caries.
• History of pain or swelling.
• Endodontically treated teeth.
• Mobility grade 1 or 2
• Non-carious cervical abfraction lesions

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

CMW cement

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The assessors, statistician and the patients will be blinded to intervention/control assessment methods; Triple blinded study. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share