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