Class V Dental CariesNCT05614076
Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin
A study testing conserved chalky white enamel margins of class V cavities and Total removal of demineralized enamel margins of class V cavities in people with Class V Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the clinical performance of conserved chalky white demineralized enamel margins with total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Class V Dental Caries
- What is being tested?
- conserved chalky white enamel margins of class V cavities and Total removal of demineralized enamel margins of class V cavities
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Nov 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- class V carious lesions in premolars and molars.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Who cannot join
- Deep carious defects (close to pulp, less than 1 mm distance).
- Periapical pathology or signs of pulpal pathology.
- Endodontically treated teeth
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion or occlusal contacts or history of bruxism.
- Severe periodontal affection
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, Cairo University
Cairo, 11511
About this study
This study aims to compare the clinical performance of conserved chalky white demineralized enamel margins with total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions
Read the detailed description
With limited evidence-based information about the clinical performance of conserved white chalky enamel margins in class v .it is beneficial to compare the newly concept of preserved the white chalky deminerlized enamel margins using a randomized clinical trial to test the null hypothesis that this new concept has the same clinical performance as total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions .The comparator will be the concept of total removal of demineralized enamel margins in class v cavities restored with composite Patients are selected according to the eligibility criteria, Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For the comparator group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For interventional group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For control group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For experimental group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. both cavities groups restored with resin composite restorations. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures
- Conditions
- Class V Dental Caries
- Being tested
- conserved chalky white enamel margins of class V cavities, Total removal of demineralized enamel margins of class V cavities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conserved chalky white enamel margins of class V cavitiesProcedure or surgery
during cavity preparation, we conserved chalky white enamel margins of class V cavities and then restored them with resin composite restorations,we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria
Total removal of demineralized enamel margins of class V cavitiesProcedure or surgery
during cavity preparation, we removed the total chalky white enamel margins of class V cavities and then restored them with resin composite restorations, we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria
| Study group | Role | What they receive |
|---|---|---|
| Conservation of the demineralized chalky white enamel margin of class V cavities | Experimental | for cavity design in this arm we Conserved the demineralized chalky white enamel margin of class V cavities then application of resin composite restoration Receives: Procedure: conserved chalky white enamel margins of class V cavities |
| Total removal of demineralized enamel margin of class V cavities | Active comparator | for cavity design in this arm is Total removal of demineralized enamel margin of class V cavities and restoration with resin composite Receives: Procedure: Total removal of demineralized enamel margins of class V cavities |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal discoloration
ordinal criteria scoring system (ordinal)
Measured: 3 months
marginal discoloration
ordinal criteria scoring system (ordinal)
Measured: 6 months
marginal discoloration
ordinal criteria scoring system (ordinal)
Measured: 12 months
Secondary outcomes (3)
color change
ordinal criteria scoring system (ordinal)
Measured: 3 month
color change
ordinal criteria scoring system (ordinal)
Measured: 6 month
color change
ordinal criteria scoring system (ordinal)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start4 Nov 2021
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Class V Dental 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
- Model description
- 1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Salim Dawood, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614076
- Sponsor's protocol ID
- 14422019474770
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdalla AI, Garcia-Godoy F. Clinical performance of a self-etch adhesive in Class V restorations made with and without acid etching. J Dent. 2007 Jul;35(7):558-63. doi: 10.1016/j.jdent.2007.02.006. Epub 2007 Apr 27.
PubMed 17467137Alexandria AK, Nassur C, Nobrega CBC, Valenca AMG, Rosalen PL, Maia LC. In situ effect of titanium tetrafluoride varnish on enamel demineralization. Braz Oral Res. 2017 Nov 6;31:e86. doi: 10.1590/1807-3107BOR-2017.vol31.0086.
PubMed 29116298Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available.
PubMed 16421996Baratieri LN, Ritter AV. Critical appraisal. To bevel or not in anterior composites. J Esthet Restor Dent. 2005;17(4):264-9. doi: 10.1111/j.1708-8240.2005.tb00126.x.
PubMed 16231497Chen H, Liu X, Dai J, Jiang Z, Guo T, Ding Y. Effect of remineralizing agents on white spot lesions after orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2013 Mar;143(3):376-382.e3. doi: 10.1016/j.ajodo.2012.10.013.
PubMed 23452972Kielbassa AM, Ulrich I, Schmidl R, Schuller C, Frank W, Werth VD. Resin infiltration of deproteinised natural occlusal subsurface lesions improves initial quality of fissure sealing. Int J Oral Sci. 2017 Jun;9(2):117-124. doi: 10.1038/ijos.2017.15. Epub 2017 Jun 16.
PubMed 28621326Korner P, El Gedaily M, Attin R, Wiedemeier DB, Attin T, Taubock TT. Margin Integrity of Conservative Composite Restorations after Resin Infiltration of Demineralized Enamel. J Adhes Dent. 2017;19(6):483-489. doi: 10.3290/j.jad.a39280.
PubMed 29152623Lata S, Varghese NO, Varughese JM. Remineralization potential of fluoride and amorphous calcium phosphate-casein phospho peptide on enamel lesions: An in vitro comparative evaluation. J Conserv Dent. 2010 Jan;13(1):42-6. doi: 10.4103/0972-0707.62634.
PubMed 20582219Koc Vural U, Kerimova L, Kiremitci A. Clinical comparison of a micro-hybride resin-based composite and resin modified glass ionomer in the treatment of cervical caries lesions: 36-month, split-mouth, randomized clinical trial. Odontology. 2021 Apr;109(2):376-384. doi: 10.1007/s10266-020-00550-8. Epub 2020 Sep 9.
PubMed 32902766Brkanovic S, Ivanisevic A, Miletic I, Mezdic D, Jukic Krmek S. Effect of Nano-Filled Protective Coating and Different pH Enviroment on Wear Resistance of New Glass Hybrid Restorative Material. Materials (Basel). 2021 Feb 5;14(4):755. doi: 10.3390/ma14040755.
PubMed 33562810
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin
- ClinicalTrials.gov ID
- NCT05614076
- Acronym / sponsor ID
- 14422019474770
- Conditions
- Class V Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 14 Nov 2022 (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 aims to compare the clinical performance of conserved chalky white demineralized enamel margins with total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions
Detailed description
With limited evidence-based information about the clinical performance of conserved white chalky enamel margins in class v .it is beneficial to compare the newly concept of preserved the white chalky deminerlized enamel margins using a randomized clinical trial to test the null hypothesis that this new concept has the same clinical performance as total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions .The comparator will be the concept of total removal of demineralized enamel margins in class v cavities restored with composite Patients are selected according to the eligibility criteria, Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For the comparator group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For interventional group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For control group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For experimental group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. both cavities groups restored with resin composite restorations. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1
| Arm | Type | Receives |
|---|---|---|
| Conservation of the demineralized chalky white enamel margin of class V cavities | Experimental | Procedure: conserved chalky white enamel margins of class V cavitiesfor cavity design in this arm we Conserved the demineralized chalky white enamel margin of class V cavities then application of resin composite restoration |
| Total removal of demineralized enamel margin of class V cavities | Active comparator | Procedure: Total removal of demineralized enamel margins of class V cavitiesfor cavity design in this arm is Total removal of demineralized enamel margin of class V cavities and restoration with resin composite |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- class V carious lesions in premolars and molars.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Key exclusion criteria (7 listed)
- Deep carious defects (close to pulp, less than 1 mm distance).
- Periapical pathology or signs of pulpal pathology.
- Endodontically treated teeth
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
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 |
|---|---|---|
| conserved chalky white enamel margins of class V cavitiesduring cavity preparation, we conserved chalky white enamel margins of class V cavities and then restored them with resin composite restorations,we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria | Procedure or surgery | Conservation of the demineralized chalky white enamel margin of class V cavities |
| Total removal of demineralized enamel margins of class V cavitiesduring cavity preparation, we removed the total chalky white enamel margins of class V cavities and then restored them with resin composite restorations, we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria | Procedure or surgery | Total removal of demineralized enamel margin of class V cavities |
Primary outcome
marginal discoloration
Time frame: 3 months
ordinal criteria scoring system (ordinal)
marginal discoloration
Time frame: 6 months
ordinal criteria scoring system (ordinal)
marginal discoloration
Time frame: 12 months
ordinal criteria scoring system (ordinal)
3 secondary outcomes
color change
Time frame: 3 month
color change
Time frame: 6 month
color change
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 17467137Abdalla AI, Garcia-Godoy F. Clinical performance of a self-etch adhesive in Class V restorations made with and without acid etching. J Dent. 2007 Jul;35(7):558-63. doi: 10.1016/j.jdent.2007.02.006. Epub 2007 Apr 27.
- Background: PubMed 29116298Alexandria AK, Nassur C, Nobrega CBC, Valenca AMG, Rosalen PL, Maia LC. In situ effect of titanium tetrafluoride varnish on enamel demineralization. Braz Oral Res. 2017 Nov 6;31:e86. doi: 10.1590/1807-3107BOR-2017.vol31.0086.
- Background: PubMed 16421996Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available.
- Background: PubMed 16231497Baratieri LN, Ritter AV. Critical appraisal. To bevel or not in anterior composites. J Esthet Restor Dent. 2005;17(4):264-9. doi: 10.1111/j.1708-8240.2005.tb00126.x.
- Background: PubMed 23452972Chen H, Liu X, Dai J, Jiang Z, Guo T, Ding Y. Effect of remineralizing agents on white spot lesions after orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2013 Mar;143(3):376-382.e3. doi: 10.1016/j.ajodo.2012.10.013.
- Background: PubMed 28621326Kielbassa AM, Ulrich I, Schmidl R, Schuller C, Frank W, Werth VD. Resin infiltration of deproteinised natural occlusal subsurface lesions improves initial quality of fissure sealing. Int J Oral Sci. 2017 Jun;9(2):117-124. doi: 10.1038/ijos.2017.15. Epub 2017 Jun 16.
- Background: PubMed 29152623Korner P, El Gedaily M, Attin R, Wiedemeier DB, Attin T, Taubock TT. Margin Integrity of Conservative Composite Restorations after Resin Infiltration of Demineralized Enamel. J Adhes Dent. 2017;19(6):483-489. doi: 10.3290/j.jad.a39280.
- Background: PubMed 20582219Lata S, Varghese NO, Varughese JM. Remineralization potential of fluoride and amorphous calcium phosphate-casein phospho peptide on enamel lesions: An in vitro comparative evaluation. J Conserv Dent. 2010 Jan;13(1):42-6. doi: 10.4103/0972-0707.62634.
- Background: PubMed 32902766Koc Vural U, Kerimova L, Kiremitci A. Clinical comparison of a micro-hybride resin-based composite and resin modified glass ionomer in the treatment of cervical caries lesions: 36-month, split-mouth, randomized clinical trial. Odontology. 2021 Apr;109(2):376-384. doi: 10.1007/s10266-020-00550-8. Epub 2020 Sep 9.
- Background: PubMed 33562810Brkanovic S, Ivanisevic A, Miletic I, Mezdic D, Jukic Krmek S. Effect of Nano-Filled Protective Coating and Different pH Enviroment on Wear Resistance of New Glass Hybrid Restorative Material. Materials (Basel). 2021 Feb 5;14(4):755. doi: 10.3390/ma14040755.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conserved chalky white enamel margins of class V cavities and Total removal of demineralized enamel margins of class V cavities in people with Class V Dental Caries, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryam Salim Dawood, master (00201011270500, maryam.salim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal discoloration (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT05614076, which also lists 10 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 9 Feb 2023.