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)

NCT05029479 | Unknown

• 1 other identifier: Novel YAMAKIN TMR-Aquabond0
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Non-carious Cervical Lesions; Geriatric Patients

Keywords

Non-Carious cervical lesions

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• 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

  12 months

Secondary Outcomes (2)

• Number of restoration with change in colour or texture

  12 months

• Number of restoration caused biological harm

  12 months

Study Arms (2)

Yamakin TMR-Aquabond0

EXPERIMENTAL

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

Other: Bonding in NCCLs

3m ESPE Single Bond Universal Adhesive

ACTIVE COMPARATOR

Conventional Universal Adhesive

Other: Bonding in NCCLs

Interventions

Bonding in NCCLs OTHER

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

3m ESPE Single Bond Universal Adhesive; Yamakin TMR-Aquabond0

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Inadequate oral hygiene
• Bruxism
• High caries activity
• Non-vital pulp
• Severe periodontal diseases
• Severe dysgnathia/traumatic occlusion
• Undergoing orthodontic treatments
• Undergoing bleaching procedures

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry , Cairo University

Cairo, 02022, Egypt

Location

Related Publications (13)

• 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.

  PMID: 29935766 RESULT

• 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.

  PMID: 32486393 RESULT

• 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.

  PMID: 27778115 RESULT

• 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.

  PMID: 32031090 RESULT

• 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.

  PMID: 31994534 RESULT

• 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.

  PMID: 24814138 RESULT

• 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.

  PMID: 33551590 RESULT

• 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.

  PMID: 20847997 RESULT

• 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.

  PMID: 28962842 RESULT

• 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.

  PMID: 22632386 RESULT

• 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.

  PMID: 26774320 RESULT

• 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.

  PMID: 32933775 RESULT

• 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.

  PMID: 25139815 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Conservative dentistry department , Cairo University

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: August 31, 2021
• Study Start: October 13, 2021
• Primary Completion: October 13, 2022
• Study Completion: December 1, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)