Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months: Randomized Controlled Trial

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    30
  • sponsor
    Cairo University
Updated on 28 October 2022
Accepts healthy volunteers

Summary

Class V carious lesions will be restored using either Resin modified glass ionomer or Giomer based injectable resin composite.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria.

Description

In this study, Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or Giomer based injectable resin composite. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept. Their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received.The first group (A) (Intervention): Giomer based injectable resin composite (Beautifil Flow plus X F03, SHOFU, USA): The material will be applied according to manufacturer instructions. The second group (B) (comparator): Resin modified glass ionomer (Fuji II LC, GC): The material will be applied according to manufacturer instructions.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria (USPHS) for the following characteristics: retention, anatomical form, marginal adaptation, marginal staining, surface texture, and secondary caries . The restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable, and Charlie represents a clinically unacceptable situation.

Details
Condition Class V Dental Caries
Treatment Giomer based injectable resin composite, Resin modified glass ionomer
Clinical Study IdentifierNCT05389163
SponsorCairo University
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-60 years
Co-operative patients approving to participate in the study
Male or female patients
Patients with good general health
Moderate or high caries risk patient
Teeth Inclusion Criteria
Cervical Class V carious lesions
Pulp asymptomatic vital carious teeth

Exclusion Criteria

Systemic disease or severe medical complications
Participants with a history of allergy to any component of restorations will be used in the study
Lack of compliance
Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits
Teeth Exclusion Criteria
Presence of apical or periapical pathosis
tooth mobility
Non-vital teeth
Teeth with advanced periodontal diseases
Teeth which need indirect restoration
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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