Rct Deep Margin Elevation by Self Adhesive Composite

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-45
SponsorCairo University

About this trial

This study intend to study the development and introduction of new efficient approaches to overcome the problems of technique sensitivity of deep margin elevation by conventional flowable composite. This new class of Self- adhesive composites that have been developed and were marketed as flowable, low viscosity resin composites does not require any etching or bonding strategy before cavity filling and the ability to wet and adapt easily.The procedure is simplified by eliminating the adhesive application, which is the most technique sensitive step. (Fu J, Kakuda S, Pan F, e t al. 2013).

DME addresses multiple clinical problems associated with sub-gingival margins which pose a challenge due to limited access, rubber dam slippage over the margin and subsequent persistent saliva,

crevice fluid and blood leakage. There are uncertainties within the profession in providing DME, and it is still considered a new approach. A recent survey revealed 78% of dentists had more than one concern about the procedure, ranging from isolation and inspection, marginal adaptation, microleakage. (Taylor, Burns, 2024) FIT SA™, a new comprehensive self-adhesive flowable restorative with bioactive Giomer Technology inside. FIT SA has eliminated the need for the technique sensitive bonding procedure. FIT SA offers superior strength and polishability, and the unique filler structure combines the light transmission and diffusion properties of enamel and dentin to blend well withthe surrounding dentition.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • self adhesive flowable composite

    Other intervention

    FIT SA is a self-adhesive, light-cured, flowable restorative with two discrete viscosities, F03 (low flow) and F10 (high flow) UDMA,HEMA,Phosphonic acid monomer, S-PRG filler based on fluoroboroaluminosilicate glass, Polymerizationinitiator,Pigments and others, Shofu's exclusive GIOMER technology gives FIT SA the ability to release and recharge fluoride and other beneficial ions for the life of the restoration.

  • Conventional flowable composite

    Other intervention

    Conventional flowable composite (bulk fil)

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group 1Active comparator 1 intervention
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

post operative hyper sensitivity

Patients will be recalled at 3, 6, and 12 month post treatment to assess the occurrence of POH by verbally questioning the patient regarding sensitivity to cold, hot, sweet stimuli, mastication and clenching. Their answers about presence and degree of severity in sensitivity were measured using Visual Analogue Scale (VAS). The VAS is presented as a 10 cm horizontal line anchored by two extremes, no pain (score 0) and pain as bad as it could be (score 10). Patients were asked to choose the mark that represented their degree of pain, which was assigned to be one of four categorical score: None; (0), Mild (1- 3), Moderate (4-6) and Severe (7-10). All the readings (marks) stated by the patients will be recorded and then the amount of pain will be assessed. Data will be collected, computerized and statistically analyzed using Medcalc software, version 22 for windows (MedCalc Software Ltd, Ostend, Belgium)

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Cairo University

Lead sponsor

Kasr El Aini Hospital

Sponsor institution

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