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)

NCT ID: NCT05029479

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-13

Study Completion Date

2022-12-31

Brief Summary

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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)

Detailed Description

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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

Conditions

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Non-carious Cervical Lesions Geriatric Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Yamakin TMR-Aquabond0

Novel Moisture Resistant, M-TEG-P Phosphate Monomer Based Universal Adhesive (YAMAKIN TMR-Aquabond0)

Group Type EXPERIMENTAL

Bonding in NCCLs

Intervention Type OTHER

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

3m ESPE Single Bond Universal Adhesive

Conventional Universal Adhesive

Group Type ACTIVE_COMPARATOR

Bonding in NCCLs

Intervention Type OTHER

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

Interventions

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Bonding in NCCLs

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Lack of written informed consent to participate
2. Cervical hypersensitivities
3. Underage patients
4. Allergies to components of the materials used
5. Infectious diseases
6. Mucosal diseases with unclear diagnosis
7. Inadequate oral hygiene
8. Bruxism
9. High caries activity
10. Non-vital pulp
11. Severe periodontal diseases
12. Severe dysgnathia/traumatic occlusion
13. Undergoing orthodontic treatments
14. Undergoing bleaching procedures
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hend Taha Hanafi Mahmoud

Resident in Conservative dentistry department , Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry , Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 29935766 (View on PubMed)

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.

Reference Type RESULT
PMID: 32486393 (View on PubMed)

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.

Reference Type RESULT
PMID: 27778115 (View on PubMed)

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.

Reference Type RESULT
PMID: 32031090 (View on PubMed)

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.

Reference Type RESULT
PMID: 31994534 (View on PubMed)

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.

Reference Type RESULT
PMID: 24814138 (View on PubMed)

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.

Reference Type RESULT
PMID: 33551590 (View on PubMed)

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.

Reference Type RESULT
PMID: 20847997 (View on PubMed)

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.

Reference Type RESULT
PMID: 28962842 (View on PubMed)

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.

Reference Type RESULT
PMID: 22632386 (View on PubMed)

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.

Reference Type RESULT
PMID: 26774320 (View on PubMed)

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.

Reference Type RESULT
PMID: 32933775 (View on PubMed)

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.

Reference Type RESULT
PMID: 25139815 (View on PubMed)

Other Identifiers

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Novel YAMAKIN TMR-Aquabond0

Identifier Type: -

Identifier Source: org_study_id

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