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Non-carious Cervical LesionsNCT05029479

the Clinical Performance of a Moisture Resistant, M-TEG-P Phosphate Monomer Based Universal Adhesive (YAMAKIN TMR-Aquabond0) Compared to the Conventional Universal Adhesive (3m ESPE Single Bond Universal Adhesive)

A study testing Bonding in NCCLs in people with Non-carious Cervical Lesions and Geriatric Patients, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

this trial is to test the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs) Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Bonding in NCCLs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteEgypt
Study dates
13 Oct 2021to Dec 2022
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Non-carious cervical lesions in anterior and posterior teeth.
  • Geriatric patients from age 60 years and above.
  • Patients willing to commit to the whole period of the study.
  • Males \& Females included.

Who cannot join

  • Lack of written informed consent to participate
  • Cervical hypersensitivities
  • Underage patients
  • Allergies to components of the materials used
  • Infectious diseases
  • Mucosal diseases with unclear diagnosis
Show all 14Show fewer
  • Inadequate oral hygiene
  • Bruxism
  • High caries activity
  • Non-vital pulp
  • Severe periodontal diseases
  • Severe dysgnathia/traumatic occlusion
  • Undergoing orthodontic treatments
  • Undergoing bleaching procedures

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Dentistry , Cairo University

    Cairo, 02022

Other trials in Egypt

About this study

Official title: Clinical Performance of a Moisture Resistant, M-TEG-P Phosphate Monomer-based Universal Adhesive in Geriatric Patients With Non-carious Cervical Lesions (NCLLs):A Randomized Clinical Trial

this trial is to test the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)

Read the detailed description

To evaluate the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)

P: Population: Geriatric patients with non-carious cervical lesions (NCCLs) I: Intervention: Novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) C: Comparator : 3m ESPE Single Bond Universal Adhesive O: Outcome:Clinical Performance using FDI criteria

Being tested
Bonding in NCCLs
Keywords
Non-Carious cervical lesions

What participants receive

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

  • Bonding in NCCLsOther

    bonding agent which can resist moisture and has shorter decalcifying and curing time

Study groups in NCT05029479
Study groupRoleWhat they receive
Yamakin TMR-Aquabond0ExperimentalNovel Moisture Resistant, M-TEG-P Phosphate Monomer Based Universal Adhesive (YAMAKIN TMR-Aquabond0)
Receives: Other: Bonding in NCCLs
3m ESPE Single Bond Universal AdhesiveActive comparatorConventional Universal Adhesive
Receives: Other: Bonding in NCCLs

What is being measured

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

  1. Number of fractured restorations

    First, visual inspection to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure there is no rocking /fracture /ditching in the restoration following FDI criteria ( first visually for total loss followed by tactile inspection using FDI probe for any fracture /rocking or loss of retention.

    Measured: 12 months

  2. Number of restorations with retention loss

    First, visual inspection to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria

    Measured: 12 months

Secondary outcomes (2)

  1. Number of restoration with change in colour or texture

    Evaluation will be done visually following FDI criteria to ensure no change in colour or texture of the restoration

    Measured: 12 months

  2. Number of restoration caused biological harm

    Evaluation will be done following FDI criteria using FDI probe to ensure there is no change in restoration that caused any harm to the health of biological structure

    Measured: 12 months

Timeline

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

  1. First posted31 Aug 2021
  2. Study start13 Oct 2021
  3. Primary completion13 Oct 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05029479
Sponsor's protocol ID
Novel YAMAKIN TMR-Aquabond0
Status last verified
Jul 2022
First submitted
21 Aug 2021
Last updated
21 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Y, Hu X, Xia Y, Ji Y, Ruan J, Weir MD, Lin X, Nie Z, Gu N, Masri R, Chang X, Xu HHK. Novel magnetic nanoparticle-containing adhesive with greater dentin bond strength and antibacterial and remineralizing capabilities. Dent Mater. 2018 Sep;34(9):1310-1322. doi: 10.1016/j.dental.2018.06.001. Epub 2018 Jun 21.

    PubMed 29935766

  • Wawrzynkiewicz A, Rozpedek-Kaminska W, Galita G, Lukomska-Szymanska M, Lapinska B, Sokolowski J, Majsterek I. The Cytotoxicity and Genotoxicity of Three Dental Universal Adhesives-An In Vitro Study. Int J Mol Sci. 2020 May 31;21(11):3950. doi: 10.3390/ijms21113950.

    PubMed 32486393

  • Santis LR, Silva TM, Haddad BA, Goncalves LL, Goncalves SE. Influence of dentin thickness on intrapulpal temperature under simulated pulpal pressure during Nd:YAG laser irradiation. Lasers Med Sci. 2017 Jan;32(1):161-167. doi: 10.1007/s10103-016-2098-1. Epub 2016 Oct 24.

    PubMed 27778115

  • Akarsu S, Karademir SA, Ertas E, Atasoy S. The effect of diode laser application on restoration of non carious cervical lesion: Clinical follow up. Niger J Clin Pract. 2020 Feb;23(2):165-171. doi: 10.4103/njcp.njcp_399_19.

    PubMed 32031090

  • Peumans M, Politano G, Van Meerbeek B. Treatment of noncarious cervical lesions: when, why, and how. Int J Esthet Dent. 2020;15(1):16-42.

    PubMed 31994534

  • Wagner A, Wendler M, Petschelt A, Belli R, Lohbauer U. Bonding performance of universal adhesives in different etching modes. J Dent. 2014 Jul;42(7):800-7. doi: 10.1016/j.jdent.2014.04.012. Epub 2014 May 6.

    PubMed 24814138

  • Ranjitha GR, Vikram R, Meena N, Vijayalakshmi L, Murthy CS. Clinical efficacy of universal adhesives for the restoration of noncarious cervical lesions: A randomized clinical trial. J Conserv Dent. 2020 May-Jun;23(3):227-232. doi: 10.4103/JCD.JCD_51_20. Epub 2020 Dec 4.

    PubMed 33551590

  • Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.

    PubMed 20847997

  • Loguercio AD, Luque-Martinez IV, Fuentes S, Reis A, Munoz MA. Effect of dentin roughness on the adhesive performance in non-carious cervical lesions: A double-blind randomized clinical trial. J Dent. 2018 Feb;69:60-69. doi: 10.1016/j.jdent.2017.09.011. Epub 2017 Sep 27.

    PubMed 28962842

  • Milia E, Cumbo E, Cardoso RJ, Gallina G. Current dental adhesives systems. A narrative review. Curr Pharm Des. 2012;18(34):5542-52. doi: 10.2174/138161212803307491.

    PubMed 22632386

  • Sawlani K, Lawson NC, Burgess JO, Lemons JE, Kinderknecht KE, Givan DA, Ramp L. Factors influencing the progression of noncarious cervical lesions: A 5-year prospective clinical evaluation. J Prosthet Dent. 2016 May;115(5):571-7. doi: 10.1016/j.prosdent.2015.10.021. Epub 2016 Jan 7.

    PubMed 26774320

  • de Paris Matos T, Perdigao J, de Paula E, Coppla F, Hass V, Scheffer RF, Reis A, Loguercio AD. Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. Dent Mater. 2020 Nov;36(11):1474-1485. doi: 10.1016/j.dental.2020.08.007. Epub 2020 Sep 12.

    PubMed 32933775

  • Luque-Martinez IV, Perdigao J, Munoz MA, Sezinando A, Reis A, Loguercio AD. Effects of solvent evaporation time on immediate adhesive properties of universal adhesives to dentin. Dent Mater. 2014 Oct;30(10):1126-35. doi: 10.1016/j.dental.2014.07.002. Epub 2014 Aug 16.

    PubMed 25139815

Questions about this trial

What is this clinical trial studying?

A study testing Bonding in NCCLs in people with Non-carious Cervical Lesions and Geriatric Patients, 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 4 inclusion and 14 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 21 Jul 2022. 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?

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?

Number of fractured restorations (time frame: 12 months). The study lists 2 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 NCT05029479, which also lists 13 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 21 Jul 2022.

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