Deep Margin ElevationNCT06899412
Rct Deep Margin Elevation by Self Adhesive Composite
A study testing self adhesive flowable composite and Conventional flowable composite in people with Deep Margin Elevation, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Deep Margin Elevation
- What is being tested?
- self adhesive flowable composite and Conventional flowable composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Sep 2026
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Clinical Evaluation of Success Rate of Deep Marginal Elevation Technique Using Self-adhesive Flowable Composite Versus Conventional Bonded Flowable Composite: Randomized Clinical 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.
Read the detailed description
Deep margin elevation (DME), or coronal margin relocation (CMR), is a procedure used to raise or reposition sub-gingival margins into supra-gingival margins using several materials to increase marginal integrity and bonding strength. Dietschi and Spreafico proposed the DME technique in 1998 to solve the problems associated with sub-gingival restorations. Despite this fact, it is still considered a new approach. Nowadays, clinical dentistry is directed toward conservatism, where in several situations the minimally invasive DME can replace the invasive procedures of crown lengthening. Sub-gingival preparations present difficulties that may complicate all further steps, such as rubber dam isolation, impression taking both digitally and traditionally, placement of a restoration, cementation as well as cervical area finishing and polishing. Moreover, indirect partial posterior restorations often display sub- gingival margins, which are accompanied by both biological and operative problems. Operative problems are attributed to changes in the tooth structure that are associated with deep margins, such as the absence of enamel, where dentin and cementum will pose more difficulties in bonding. Up until now, there is a limitation in the studies assessing the advantages and limitations of DME, most of them are in vitro concentrating on fracture resistance, bond strength, and marginal adaptation of indirect restorations. (Aldakheel, Almuhtab et al.2022).
- Conditions
- Deep Margin Elevation
- Being tested
- self adhesive flowable composite, Conventional flowable composite
- Keywords
- deep margin, composite restorations, class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self adhesive flowable compositeOther
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 compositeOther
Conventional flowable composite (bulk fil)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Other: Conventional flowable composite |
| Group 2 | Experimental | Not described Receives: Other: self adhesive flowable composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Margin ElevationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Elsayed Ramadan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899412
- Sponsor's protocol ID
- 14422023446877
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Success Rate of Deep Marginal Elevation Technique Using Self-adhesive Flowable Composite Versus Conventional Bonded Flowable Composite: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06899412
- Acronym / sponsor ID
- 14422023446877
- Conditions
- Deep Margin Elevation
- Keywords
- deep margin, composite restorations, class II
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 Mar 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 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.
Detailed description
Deep margin elevation (DME), or coronal margin relocation (CMR), is a procedure used to raise or reposition sub-gingival margins into supra-gingival margins using several materials to increase marginal integrity and bonding strength. Dietschi and Spreafico proposed the DME technique in 1998 to solve the problems associated with sub-gingival restorations. Despite this fact, it is still considered a new approach. Nowadays, clinical dentistry is directed toward conservatism, where in several situations the minimally invasive DME can replace the invasive procedures of crown lengthening. Sub-gingival preparations present difficulties that may complicate all further steps, such as rubber dam isolation, impression taking both digitally and traditionally, placement of a restoration, cementation as well as cervical area finishing and polishing. Moreover, indirect partial posterior restorations often display sub- gingival margins, which are accompanied by both biological and operative problems. Operative problems are attributed to changes in the tooth structure that are associated with deep margins, such as the absence of enamel, where dentin and cementum will pose more difficulties in bonding. Up until now, there is a limitation in the studies assessing the advantages and limitations of DME, most of them are in vitro concentrating on fracture resistance, bond strength, and marginal adaptation of indirect restorations. (Aldakheel, Almuhtab et al.2022).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Conventional flowable composite |
| Group 2 | Experimental | Other: self adhesive flowable composite |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| self adhesive flowable compositeFIT 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. | Other | Group 2 |
| Conventional flowable compositeConventional flowable composite (bulk fil) | Other | Group 1 |
Primary outcome
post operative hyper sensitivity
Time frame: 1 year
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)
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 28 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing self adhesive flowable composite and Conventional flowable composite in people with Deep Margin Elevation, run by Cairo 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 4 inclusion and 2 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 28 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative hyper sensitivity (time frame: 1 year). 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 28 Mar 2025.