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)

Geriatric Patients Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05029479
• Other study ID #: Novel YAMAKIN TMR-Aquabond0
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: December 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatric Patients
• Non-carious Cervical Lesions
• Uterine Cervical Diseases

Intervention

Other:
• Bonding in NCCLs
bonding agent which can resist moisture and has shorter decalcifying and curing time

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry , Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

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. — View Citation

de Paris Matos T, Perdigão 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 — View Citation

Hickel R, Peschke A, Tyas M, Mjör 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 — View Citation

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):1310-13 — View Citation

Loguercio AD, Luque-Martinez IV, Fuentes S, Reis A, Muñoz 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. Ep — View Citation

Luque-Martinez IV, Perdigão J, Muñoz 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 — View Citation

Milia E, Cumbo E, Cardoso RJ, Gallina G. Current dental adhesives systems. A narrative review. Curr Pharm Des. 2012;18(34):5542-52. Review. — View Citation

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. — View Citation

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. E — View Citation

Santis LR, Silva TM, Haddad BA, Gonçalves LL, Gonçalves 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. E — View Citation

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.2 — View Citation

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. — View Citation

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). pii: E3950. doi: 10.3 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	12 months
Secondary	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	12 months