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Gingival Margin ElevationNCT06944080

Effect of Different Base Materials on Ginigiva During Gingival Margin Elevation

A study testing base material(Tetric® N-Flow,Beautifil-Flow PLUS,GC fuji II LC capsule) in people with Gingival Margin Elevation, run by Minia University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will be conducted to investigate 1. The effect of deep margin elevation with different base materials (resin modified glass ionomer, flowable composite, injectable hybrid composite) on fracture resistance and marginal quality of direct and indirect resin composite inlay (in vitro). 2. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Margin Elevation
What is being tested?
base material(Tetric® N-Flow,Beautifil-Flow PLUS,GC fuji II LC capsule)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Apr 2025to Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • good oral hygien
  • upper premolar teeth

Who cannot join

  • badly destructed tooth

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

rofida ragab mohamed contact

01144490523

rofidaragab301@gmail.com

mona ismail riad contact

01006608683

monariad50@hotmail.com

About this study

Official title: Effect of Deep Margin Elevation With Different Base Materials on Fracture Resistance of Direct and Indirect Resin Composite Restorations and Periodontal Health(Clinical and Experimental Studies)

This study will be conducted to investigate

  1. The effect of deep margin elevation with different base materials (resin modified glass ionomer, flowable composite, injectable hybrid composite) on fracture resistance and marginal quality of direct and indirect resin composite inlay (in vitro).
  2. The effect of deep margin elevation with different base materials (resin modified glass ionomer, flowable composite, injectable hybrid composite) on periodontal health (in vivo study).
Read the detailed description

The dental clinician has consistently challenged the restoration of deep proximal lesions since they are usually associated with significant defects with subgingival margins exceeding cementoenamel junction (CEJ).

In this clinical scenario, indirect restorations are preferable since they provide better esthetic, anatomic form, physical and mechanical properties, and reduced polymerization shrinkage due to their extraoral fabrication that permits the relief of residual stresses .

However, subgingival margins remain a challenge as they are challenging to handle due to limited access, rubber dam slippage over the margin, and subsequent persistent saliva, crevice fluid and blood leakage.

The conventional approach includes orthodontic extrusion, surgical exposure of the cervical margin, or a combination of both techniques leading to an apical displacement of supporting tissues to access the subgingival margin and obtain adequate space for the establishment of biological width (BW).

Frequently, these techniques mentioned above may cause further attachment loss and exposure of root concavities and furcation's to the oral environment, dentin hypersensitivity, and unfavorable crown to root ratio as well as compromised esthetics. Additionally, this process may often delay the delivery of the final restoration.

An alternative and more conservative approach, the so-called "deep margin elevation" (DME), is to apply a base over the preexisting cervical margin to relocate it coronally.

This technique introduced in 1998 by Dietschi and Spreafico is also referred to with the terms "cervical margin relocation", "proximal box elevation", and "coronal margin relocation", and presents several benefits concerning proper isolation with a rubber dam and subsequent moisture control, facilitation in impression taking, proper bonding procedures, and excess removal and avoidance of unnecessary tissue sacrifice.

The open-sandwich technique is widely considered the forerunner of DME introduced to overcome sealing issues in deep Class II direct composite restorations, the open-sandwich technique uses a glass ionomer or resin-modified glass ionomer (RM-GIC) to fill the cervical part of the box, which results in a part of the glass ionomer/resin-modified glass ionomer being exposed to the oral environment.

However, even if the two techniques resemble each other, DME was initially described for indirect restorations using composite resin. The adhesive composite resin base is used to seal the dentin, correct geometry, reinforce undermined cusps, and fill undercuts.

Flowable composite bases and liners may also act as stress absorbers or stress breakers during the insertion and polymerization of subsequent layers or during functional loading. Beside other physical properties, the elastic modulus of the restorative material plays a major role for the stress-absorbing effect.

RM-GIC releases fluoride, hydrophilic nature, flexibility, chemical bonding and enhanced mechanical and wear properties of their newer generations, could be a more suitable option for bonding to deep moist dentin/cementum margins.

A base, liner, and final restorative all in one; Beautifil Flow Plus is the next step in the evolution of restorative materials, combining the convenience of a flowable delivery system with strength and functionality that surpass leading hybrid composites, superior adaptation ensures a tight marginal seal, decreasing voids, high radiopacity allows clear visibility during follow-ups and Fluoride release and recharge is ideal for high caries index patients.

When the marginal ridges are involved in large lesions; it is wise to plan for indirect restorations (IRs), the strength of the tooth is directly proportional to the integrity of the marginal ridges. Depending on the extent of tooth structure loss, the need for cuspal coverage and the amount of reinforcement needed.

IRs such as inlays, onlays, overlays and full-contour crowns are recommended. Historically, IRs fabricated using gold alloys were considered the gold standard. However, due to increased demand for more natural and esthetic restorations, the use of composites and ceramics have overhauled the use of metals.

Fracture is considered the most common reason for replacing fixed partial prostheses. For this reason, when considering the long-term viability of a dental material for fabricating restorations, it is essential to test its fracture resistance.

So, this study will be conducted to investigate the effect of proximal box elevation at different depth level with three base materials (resin modified glass ionomer, flowable composite and injectable hybrid composite) and its influence on fracture resistance of premolars teeth restored with direct and indirect composite inlay.

The null hypothesis tested that there is no significant difference in the effect of deep margin elevation with (RM-GI and Flowable composite) base materials on fracture resistance and marginal quality of direct and indirect resin composite when compared to injectable hybrid composite.

Being tested
base material(Tetric® N-Flow,Beautifil-Flow PLUS,GC fuji II LC capsule)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • base material(Tetric® N-Flow,Beautifil-Flow PLUS,GC fuji II LC capsule)Other

    subgingival restoration, deep marginal elevation procedure with different base materials will be applied then plaque index, gingival index, probing depth, clinical attachment level and biochemical marker will be measured at base line and after 3 months.

Study groups in NCT06944080
Study groupRoleWhat they receive
The effect of deep Margin elevation with different base materials on periodontal healthExperimentalThe effect of deep Margin elevation with different base materials (resin modified glass ionomer, flowable composite, injectable hybrid composite) on periodontal health (in vivo study)will be applied then plaque index, gingival index, probing depth, clinical attachment level and biochemical marker will be measured at base line and after 3 months
Receives: Other: base material(Tetric® N-Flow,Beautifil-Flow PLUS,GC fuji II LC capsule)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of deep Margin elevation with different base materials (resin modified glass ionomer, flowable composite, injectable hybrid composite) on periodontal health (in vivo study)

    after subgingival restoration(resin modified glass ionomer, flowable composite, injectable hybrid composite) will be applied to to elevate deep marginal then biochemical marker will be measured (TNF,IL-1 by pg/ml) from gingival crevicular fluid.

    Measured: base line

Secondary outcomes (1)
  1. The effect of deep Margin elevation with different base materials (resin modified glass ionomer, flowable composite, injectable hybrid composite) on periodontal health (in vivo study)

    follow up after 3 months of subgingival restoration(resin modified glass ionomer, flowable composite, injectable hybrid composite) will be applied to to elevate deep marginal to measure level of biochemical marker in gingival crevicular fluid (TNF,IL-1 by pg/ml)

    Measured: after 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2025
  2. Study startApr 2025 (estimated)
  3. Primary completionJun 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06944080
Sponsor's protocol ID
gingival marginal elevation
Status last verified
Jan 2025
First submitted
10 Apr 2025
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing base material(Tetric® N-Flow,Beautifil-Flow PLUS,GC fuji II LC capsule) in people with Gingival Margin Elevation, run by Minia University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact rofida ragab mohamed (01144490523, rofidaragab301@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of deep Margin elevation with different base materials (resin modified glass ionomer, flowable composite, injectable hybrid composite) on periodontal health (in vivo study) (time frame: base line). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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