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.
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)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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.
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
- 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).
- 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.
- Conditions
- Gingival Margin Elevation
- 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 group | Role | What they receive |
|---|---|---|
| The effect of deep Margin elevation with different base materials on periodontal health | Experimental | 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)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.
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)
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.
- First posted25 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Margin ElevationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rofida Ragab Mohamed, Minia University
- Investigators
- ahmed abdallah khalil, Study director, Faculty of dentistry-Minia universityrasha saad zaghlool, Study director, Faculty of dentistry-Minia university
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06944080
- Acronym / sponsor ID
- gingival marginal elevation
- Conditions
- Gingival Margin Elevation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to investigate
- 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).
- 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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The effect of deep Margin elevation with different base materials on periodontal health | Experimental | Other: base material(Tetric® N-Flow,Beautifil-Flow PLUS,GC fuji II LC capsule)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)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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- good oral hygien
- upper premolar teeth
Key exclusion criteria (1 listed)
- badly destructed tooth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| base material(Tetric® N-Flow,Beautifil-Flow PLUS,GC fuji II LC capsule)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. | Other | The effect of deep Margin elevation with different base materials on periodontal health |
Primary outcome
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
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.
1 secondary outcome
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: after 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
Related trials for Gingival Margin Elevation
Recruiting
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
Deep Margin Elevation, Pulpal and Periodontal Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ahmed abdallah khalil study director
Faculty of dentistry-Minia university
rasha saad zaghlool study director
Faculty of dentistry-Minia university
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.