Clinical Performance of Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients

Universal Adhesive Clinical Trial

Official title:

Clinical Performance of Newly Introduced Self-cured Universal Adhesive for Restoring Cervical Lesions in Geriatric Patients Over One Year (A Randomized Clinical Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05054673
• Other study ID #: palfique bond
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: October 2022

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: Maysaa M Mostafa, B.D.S.
• Phone: 01001422220
• Email: mayssaa.motafa[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the study is conducted to evaluate the clinical performance of PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive), Versus 3m ESPE™ single bond Universal Adhesive, for restoring cervical lesions in geriatric patients over one year.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• The patient had to be in good general health

• Geriatric patients

• Have an acceptable oral hygiene level

• Class V cavities in anterior and posterior teeth

• Males & females included

• Anticipated availability for recalls (6 months and 12 months) through the 1-year study period

Exclusion Criteria:

• Lack of written informed consent to participate

• Poor oral hygiene,

• Severe bruxism

• Severe or chronic periodontitis

• Allergies to components of the materials used

• Underage patients

• Non vital pulp

Related Conditions & MeSH terms

• Universal Adhesive

Intervention

Other:
• universal adhesive
PALFIQUE universal adhesive
• universal adhesive
3M™ ESPE™ single bond Universal Adhesive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the Marginal adaptation	modified USPHS criteria, ordinal	1 year
Secondary	level of Retention	binary , modified USPHS criteria	1 year
Secondary	Level of Marginal discoloration	ordinal, modified USPHS criteria	1 year
Secondary	Rate of Secondary caries	binary , modified USPHS criteria	1 year
Secondary	level of Postoperative sensitivity	binary , modified USPHS criteria	1 year