Deep CariesNCT06497231
Evaluation of Bioactive Giomer Material Versus Nanohybrid Resin Composite in Deep Marginal Elevation
A study testing Beautifil II LS and Nanohybrid resin composite material in people with Deep Caries and Dental Caries, run by Cairo University.
Trial summary
This study will be conducted to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer compared to nanohybrid resin composite restoration in deep subgingival proximal cavities extending below the CEJ over a period of 24 months. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries, Dental Caries
- What is being tested?
- Beautifil II LS and Nanohybrid resin composite material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2027
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young and middle aged patients (20-50)
- Good or moderate oral hygiene (plaque index 0 or 1 )
- Patient approval
- Absence of parafunctional habits and/or bruxism
Who cannot join
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
- Patients with active periodontal disease.
- Heavy smokers
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: Clinical and Periodontal Evaluation of Deep Marginal Elevation for Proximal Carious Lesions Restored with Bioactive Giomer Versus Nanohybrid Resin Composite: Two Years Randomized Trial
This study will be conducted to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer compared to nanohybrid resin composite restoration in deep subgingival proximal cavities extending below the CEJ over a period of 24 months.
Read the detailed description
Background and rationale:
Recent development in different adhesive techniques and materials has led clinicians to attempt restoring teeth with subgingival defects below the cemento-enamel junction (CEJ). Deep marginal elevation (DME) or cervical margin relocation (CMR) is a procedure that involves raising the proximal margin of the tooth defect with direct composite to promote isolation and restoration using direct, semi-direct or indirect techniques. A high level of knowledge and clinical expertise are necessary to perform such procedure in a predictable way in addition to meticulous attention to the supracrestal tissue attachment or the biological width which consists of junctional epithelium and supracrestal connective tissue attachment.
Research question:
In young and middle-aged patients having deep subgingival proximal cavities extending below CEJ, will the bioactive Giomer show similar clinical, radiographic and periodontal performance compared to nanohybrid resin composite over 2 years follow up?
Statement of the problem:
Carious lesions that extend in subgingival areas present several difficulties for the clinician. Firstly, applying rubber dam in deep cavities and the process of trying to obtain a gingival margin free of caries are very challenging. Secondly, there is a great biological concern to master the subgingival restoration reaction with the adjacent periodontal tissues. Obtaining a healthy periodontal status after treatment has long been a challenging endeavor in the restorative dentistry. Lastly, bonding to deep, carious, and moist dentin surrounded by cementum is inherently suboptimal. To overcome these problems, many techniques and materials were presented to deal with such complex restorative situations. Because of their chemical adherence to the tooth structure, fluoride release and hydrophilicity glass ionomer cements are a reliable option for cementum margins and deep dentin bonding. Marginal defects appearing at the cervical margins due to the solubility property of the material was the main problem the dentist faced in these situations. On the other hand, resin composites are a dependable choice in these circumstances due to their higher mechanical qualities and the way their composition has improved, however, poor material bonding in subgingival margins along with high polymerization stresses associated with them have made it a very complicated procedure.
Rationale for conducting the research:
The use of fluoride releasing dental materials in deep carious lesions was explored before to remineralize the surrounding tooth structure and allow for a more durable restoration with increased resistance to the development of secondary caries. The introduction of Giomers, which combines resin composite and glass ionomer modes of action by Shofu, (Inc.) in the early 2000s was due to the revolutionary surface prereacted glass-ionomer (S-PRG) filler technology that allowed for improved resistance to recurrent caries development. Therefore, this type of bioactive system, adhesive and restoring materials, was claimed to enhance the outcome of deep subgingival restoration clinically, periodontally, and radiographically.
- Conditions
- Deep Caries, Dental Caries
- Being tested
- Beautifil II LS, Nanohybrid resin composite material
- Keywords
- Deep marginal elevation, Giomer
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beautifil II LSOther
Beautifil II LS is a low shrinkage bioactive giomer resin composite.
Nanohybrid resin composite materialOther
Nanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component.
| Study group | Role | What they receive |
|---|---|---|
| Bioactive Giomer Material | Active comparator | Deep margin elevation and subsequent restoration will be done using bioactive giomer material Receives: Other: Beautifil II LS |
| Nanohybrid resin composite | Active comparator | Deep margin elevation and subsequent restoration will be done using nanohybrid resin composite Receives: Other: Nanohybrid resin composite material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative sensitivity
Restorations will be assessed by testing of irritability of the pulpal nerve on cold, e.g., with dry ice or cold spray, in comparison to the reaction of a contralateral, sound, and unrestored tooth.
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Secondary outcomes (9)
Marginal adaptation
Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Occurrence of caries
Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Proximal Contact
Method of restorations assessment will be tactile using unwaxed dental floss to evaluate proximal contact tightness. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Plaque Index
The Plaque Index (PI) is a clinical tool used by dentists to assess the presence and severity of dental plaque accumulation on the teeth. It is scored on a scale of 0 to 3:
0: No plaque present.
- A thin film of plaque visible only with a probe or at the gingival margin.
- Moderate plaque accumulation visible to the naked eye.
- Heavy plaque accumulation visible on the tooth surface.
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Gingival Index
The Gingival Index (GI) is a clinical tool used to assess the health of the gums by evaluating the presence and severity of gingival inflammation.
Gingival Index Scoring (0 to 3):
The Gingival Index evaluates the gingiva (gums) at four sites per tooth (mesial, distal, buccal, and lingual). Each site is scored on a scale from 0 to 3:
0: Normal gingiva - No inflammation, healthy gums.
- Mild inflammation - Slight redness, no bleeding on probing, no swelling.
- Moderate inflammation - Redness, slight swelling, and bleeding on probing.
- Severe inflammation - Redness, swelling, and bleeding even without probing; possibly ulcerated or visibly infected gums.
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Interdental Pressure Index
Apical pressure of a horizontally placed periodontal probe is applied to evaluate periodontal tissue response. It is negative when gingival tissues are firm, bleeding-free, and slightly ischemic by the stimulation; otherwise it is positive.
It follows a negative or positive binary score.
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Papillary bleeding on probing Index
The Papillary Bleeding on Probing (PBI) Index is a clinical tool used to assess the presence of bleeding from the papillary gingiva (the area of gum tissue between the teeth) when a periodontal probe is gently inserted. This index helps evaluate the level of gingival inflammation and is commonly used in diagnosing gingivitis or early stages of periodontal disease.
Scoring System: The PBI uses a simple scale to score bleeding, often as follows:
0: No bleeding on probing - Healthy gingiva with no signs of inflammation.
- Bleeding on probing - A slight amount of bleeding from the papillary gingiva occurs within 15 seconds after probing.
- Bleeding on probing with immediate response - Bleeding is visible immediately after probing, indicating more significant inflammation.
- Spontaneous bleeding - Bleeding occurs without probing, indicating advanced gingival inflammation or active gum disease.
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Probing Depth
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Radiographic examination
Measured: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Deep CariesStudies 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
- Treatment
- 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, Samir Ashraf Fayez Rostom, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497231
- Sponsor's protocol ID
- Giomer in DME
- Status last verified
- Jun 2024
- First submitted
- 4 Jul 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alleman DS, Magne P. A systematic approach to deep caries removal end points: the peripheral seal concept in adhesive dentistry. Quintessence Int. 2012 Mar;43(3):197-208.
PubMed 22299120Angerame D, De Biasi M. Do Nanofilled/Nanohybrid Composites Allow for Better Clinical Performance of Direct Restorations Than Traditional Microhybrid Composites? A Systematic Review. Oper Dent. 2018 Jul/Aug;43(4):E191-E209. doi: 10.2341/17-212-L. Epub 2018 Mar 23.
PubMed 29570022Bertoldi C, Monari E, Cortellini P, Generali L, Lucchi A, Spinato S, Zaffe D. Clinical and histological reaction of periodontal tissues to subgingival resin composite restorations. Clin Oral Investig. 2020 Feb;24(2):1001-1011. doi: 10.1007/s00784-019-02998-7. Epub 2019 Jul 8.
PubMed 31286261Blatz MB, Eggmann F. Deep Margin Elevation: Next-Level Adhesive Dentistry to Avoid Surgical Crown Lengthening. Compend Contin Educ Dent. 2023 Oct;44(9):530-531.
PubMed 37850958Bresser RA, Gerdolle D, van den Heijkant IA, Sluiter-Pouwels LMA, Cune MS, Gresnigt MMM. Up to 12 years clinical evaluation of 197 partial indirect restorations with deep margin elevation in the posterior region. J Dent. 2019 Dec;91:103227. doi: 10.1016/j.jdent.2019.103227. Epub 2019 Nov 4.
PubMed 31697971Checchi L, Montevecchi M, Marucci G, Checchi V. A proposed new index for clinical evaluation of interproximal soft tissues: the interdental pressure index. Int J Dent. 2014;2014:345075. doi: 10.1155/2014/345075. Epub 2014 Apr 1.
PubMed 24799903Cushley S, Duncan HF, Lappin MJ, Chua P, Elamin AD, Clarke M, El-Karim IA. Efficacy of direct pulp capping for management of cariously exposed pulps in permanent teeth: a systematic review and meta-analysis. Int Endod J. 2021 Apr;54(4):556-571. doi: 10.1111/iej.13449. Epub 2020 Dec 28.
PubMed 33222178Donly KJ, Segura A, Wefel JS, Hogan MM. Evaluating the effects of fluoride-releasing dental materials on adjacent interproximal caries. J Am Dent Assoc. 1999 Jun;130(6):817-25. doi: 10.14219/jada.archive.1999.0305.
PubMed 10377639Eggmann F, Ayub JM, Conejo J, Blatz MB. Deep margin elevation-Present status and future directions. J Esthet Restor Dent. 2023 Jan;35(1):26-47. doi: 10.1111/jerd.13008. Epub 2023 Jan 5.
PubMed 36602272El-Ma'aita AM, Radwan H, Al-Rabab'ah MA. Deep Margin Elevation - A Retrospective Clinical Study. J Adhes Dent. 2024 Apr 11;26:117-124. doi: 10.3290/j.jad.b5199089.
PubMed 38602235Ferrari M, Koken S, Grandini S, Ferrari Cagidiaco E, Joda T, Discepoli N. Influence of cervical margin relocation (CMR) on periodontal health: 12-month results of a controlled trial. J Dent. 2018 Feb;69:70-76. doi: 10.1016/j.jdent.2017.10.008. Epub 2017 Oct 20.
PubMed 29061380Gordan VV, Blaser PK, Watson RE, Mjor IA, McEdward DL, Sensi LG, Riley JL 3rd. A clinical evaluation of a giomer restorative system containing surface prereacted glass ionomer filler: results from a 13-year recall examination. J Am Dent Assoc. 2014 Oct;145(10):1036-43. doi: 10.14219/jada.2014.57.
PubMed 25270702Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Correction to: Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2593. doi: 10.1007/s00784-022-04851-w. No abstract available.
PubMed 36607493Ismail HS, Ali AI, El Mehesen R, Garcia-Godoy F, Mahmoud SH. Clinical evaluation of subgingival open sandwich restorations: 3-year results of a randomized double-blind trial. J Esthet Restor Dent. 2024 Apr;36(4):573-587. doi: 10.1111/jerd.13158. Epub 2023 Oct 30.
PubMed 37902283LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Periodontal Evaluation of Deep Marginal Elevation for Proximal Carious Lesions Restored with Bioactive Giomer Versus Nanohybrid Resin Composite: Two Years Randomized Trial
- ClinicalTrials.gov ID
- NCT06497231
- Acronym / sponsor ID
- Giomer in DME
- Conditions
- Deep Caries, Dental Caries
- Keywords
- Deep marginal elevation, Giomer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Jul 2024 (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 evaluate the clinical, radiographic and periodontal performance of bioactive Giomer compared to nanohybrid resin composite restoration in deep subgingival proximal cavities extending below the CEJ over a period of 24 months.
Detailed description
Background and rationale:
Recent development in different adhesive techniques and materials has led clinicians to attempt restoring teeth with subgingival defects below the cemento-enamel junction (CEJ). Deep marginal elevation (DME) or cervical margin relocation (CMR) is a procedure that involves raising the proximal margin of the tooth defect with direct composite to promote isolation and restoration using direct, semi-direct or indirect techniques. A high level of knowledge and clinical expertise are necessary to perform such procedure in a predictable way in addition to meticulous attention to the supracrestal tissue attachment or the biological width which consists of junctional epithelium and supracrestal connective tissue attachment.
Research question:
In young and middle-aged patients having deep subgingival proximal cavities extending below CEJ, will the bioactive Giomer show similar clinical, radiographic and periodontal performance compared to nanohybrid resin composite over 2 years follow up?
Statement of the problem:
Carious lesions that extend in subgingival areas present several difficulties for the clinician. Firstly, applying rubber dam in deep cavities and the process of trying to obtain a gingival margin free of caries are very challenging. Secondly, there is a great biological concern to master the subgingival restoration reaction with the adjacent periodontal tissues. Obtaining a healthy periodontal status after treatment has long been a challenging endeavor in the restorative dentistry. Lastly, bonding to deep, carious, and moist dentin surrounded by cementum is inherently suboptimal. To overcome these problems, many techniques and materials were presented to deal with such complex restorative situations. Because of their chemical adherence to the tooth structure, fluoride release and hydrophilicity glass ionomer cements are a reliable option for cementum margins and deep dentin bonding. Marginal defects appearing at the cervical margins due to the solubility property of the material was the main problem the dentist faced in these situations. On the other hand, resin composites are a dependable choice in these circumstances due to their higher mechanical qualities and the way their composition has improved, however, poor material bonding in subgingival margins along with high polymerization stresses associated with them have made it a very complicated procedure.
Rationale for conducting the research:
The use of fluoride releasing dental materials in deep carious lesions was explored before to remineralize the surrounding tooth structure and allow for a more durable restoration with increased resistance to the development of secondary caries. The introduction of Giomers, which combines resin composite and glass ionomer modes of action by Shofu, (Inc.) in the early 2000s was due to the revolutionary surface prereacted glass-ionomer (S-PRG) filler technology that allowed for improved resistance to recurrent caries development. Therefore, this type of bioactive system, adhesive and restoring materials, was claimed to enhance the outcome of deep subgingival restoration clinically, periodontally, and radiographically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive Giomer Material | Active comparator | Other: Beautifil II LSDeep margin elevation and subsequent restoration will be done using bioactive giomer material |
| Nanohybrid resin composite | Active comparator | Other: Nanohybrid resin composite materialDeep margin elevation and subsequent restoration will be done using nanohybrid resin composite |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Young and middle aged patients (20-50)
- Good or moderate oral hygiene (plaque index 0 or 1 )
- Patient approval
- Absence of parafunctional habits and/or bruxism
Key exclusion criteria (5 listed)
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
- Patients with active periodontal disease.
- Heavy smokers
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 |
|---|---|---|
| Beautifil II LSBeautifil II LS is a low shrinkage bioactive giomer resin composite. | Other | Bioactive Giomer Material |
| Nanohybrid resin composite materialNanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component. | Other | Nanohybrid resin composite |
Primary outcome
Post-operative sensitivity
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Restorations will be assessed by testing of irritability of the pulpal nerve on cold, e.g., with dry ice or cold spray, in comparison to the reaction of a contralateral, sound, and unrestored tooth.
9 secondary outcomes
Marginal adaptation
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Occurrence of caries
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Proximal Contact
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Plaque Index
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Gingival Index
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Interdental Pressure Index
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Papillary bleeding on probing Index
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Probing Depth
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months
Radiographic examination
Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 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 27 Nov 2024.
- Background: PubMed 22299120Alleman DS, Magne P. A systematic approach to deep caries removal end points: the peripheral seal concept in adhesive dentistry. Quintessence Int. 2012 Mar;43(3):197-208.
- Background: PubMed 29570022Angerame D, De Biasi M. Do Nanofilled/Nanohybrid Composites Allow for Better Clinical Performance of Direct Restorations Than Traditional Microhybrid Composites? A Systematic Review. Oper Dent. 2018 Jul/Aug;43(4):E191-E209. doi: 10.2341/17-212-L. Epub 2018 Mar 23.
- Background: PubMed 31286261Bertoldi C, Monari E, Cortellini P, Generali L, Lucchi A, Spinato S, Zaffe D. Clinical and histological reaction of periodontal tissues to subgingival resin composite restorations. Clin Oral Investig. 2020 Feb;24(2):1001-1011. doi: 10.1007/s00784-019-02998-7. Epub 2019 Jul 8.
- Background: PubMed 37850958Blatz MB, Eggmann F. Deep Margin Elevation: Next-Level Adhesive Dentistry to Avoid Surgical Crown Lengthening. Compend Contin Educ Dent. 2023 Oct;44(9):530-531.
- Background: PubMed 31697971Bresser RA, Gerdolle D, van den Heijkant IA, Sluiter-Pouwels LMA, Cune MS, Gresnigt MMM. Up to 12 years clinical evaluation of 197 partial indirect restorations with deep margin elevation in the posterior region. J Dent. 2019 Dec;91:103227. doi: 10.1016/j.jdent.2019.103227. Epub 2019 Nov 4.
- Background: PubMed 24799903Checchi L, Montevecchi M, Marucci G, Checchi V. A proposed new index for clinical evaluation of interproximal soft tissues: the interdental pressure index. Int J Dent. 2014;2014:345075. doi: 10.1155/2014/345075. Epub 2014 Apr 1.
- Background: PubMed 33222178Cushley S, Duncan HF, Lappin MJ, Chua P, Elamin AD, Clarke M, El-Karim IA. Efficacy of direct pulp capping for management of cariously exposed pulps in permanent teeth: a systematic review and meta-analysis. Int Endod J. 2021 Apr;54(4):556-571. doi: 10.1111/iej.13449. Epub 2020 Dec 28.
- Background: PubMed 10377639Donly KJ, Segura A, Wefel JS, Hogan MM. Evaluating the effects of fluoride-releasing dental materials on adjacent interproximal caries. J Am Dent Assoc. 1999 Jun;130(6):817-25. doi: 10.14219/jada.archive.1999.0305.
- Background: PubMed 36602272Eggmann F, Ayub JM, Conejo J, Blatz MB. Deep margin elevation-Present status and future directions. J Esthet Restor Dent. 2023 Jan;35(1):26-47. doi: 10.1111/jerd.13008. Epub 2023 Jan 5.
- Background: PubMed 38602235El-Ma'aita AM, Radwan H, Al-Rabab'ah MA. Deep Margin Elevation - A Retrospective Clinical Study. J Adhes Dent. 2024 Apr 11;26:117-124. doi: 10.3290/j.jad.b5199089.
- Background: PubMed 29061380Ferrari M, Koken S, Grandini S, Ferrari Cagidiaco E, Joda T, Discepoli N. Influence of cervical margin relocation (CMR) on periodontal health: 12-month results of a controlled trial. J Dent. 2018 Feb;69:70-76. doi: 10.1016/j.jdent.2017.10.008. Epub 2017 Oct 20.
- Background: PubMed 25270702Gordan VV, Blaser PK, Watson RE, Mjor IA, McEdward DL, Sensi LG, Riley JL 3rd. A clinical evaluation of a giomer restorative system containing surface prereacted glass ionomer filler: results from a 13-year recall examination. J Am Dent Assoc. 2014 Oct;145(10):1036-43. doi: 10.14219/jada.2014.57.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Beautifil II LS and Nanohybrid resin composite material in people with Deep Caries and Dental Caries, 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 5 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 27 Nov 2024. 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 Samir Ashraf, BDS (01020726828, samir1401095@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative sensitivity (time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06497231, which also lists 28 linked publications.
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 27 Nov 2024.