Rct Deep Margin Elevation by Self Adhesive Composite

NCT06899412 | Not Yet Recruiting

• 1 other identifier: 14422023446877
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Deep Margin Elevation

Keywords

deep margin; composite restorations; class II

Outcome Measures

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)

  1 year

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Other: Conventional flowable composite

Group 2

EXPERIMENTAL

Other: self adhesive flowable composite

Interventions

self adhesive flowable composite OTHER

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.

Group 2

Conventional flowable composite OTHER

Conventional flowable composite (bulk fil)

Group 1

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients accept the one year follow up period. Cooperative patients. The study recruited volunteers of both genders Age from 21 to 45 years Primary compound proximal caries, with International Caries Detection and Assessment System (ICDAS) scores of 4 or 5.
• The buccolingual width of the lesion could not exceed two-thirds of the intercuspal distance.
• The remaining dentin thickness not less than 1 mm from the pulp and that could be identified clinically and by periapical xray Vital teeth without any signs of radiolucency in the periapical or furcation areas.
• Participants also had to present a moderate risk of caries.

You may not qualify if:

• Those who requiring any form of pulp capping will excluded to differentiate postoperative hypersensitivity from pulpal inflammation.
• Individuals with poor oral hygiene. Patients undergoing orthodontic treatment. Periodontal surgery patients. Smokers. Pregnant women. Patients without occlusal contact. Those suffering prolonged tooth pain that disrupted sleep.

Sponsors & Collaborators

• Cairo University: lead

Study Design

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

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03