NCT05054673

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 11, 2021

Last Update Submit

September 21, 2021

Conditions

Universal Adhesive

Outcome Measures

Primary Outcomes (1)

  • Measuring the Marginal adaptation

    modified USPHS criteria, ordinal

    1 year

Secondary Outcomes (4)

  • level of Retention

    1 year

  • Level of Marginal discoloration

    1 year

  • Rate of Secondary caries

    1 year

  • level of Postoperative sensitivity

    1 year

Study Arms (2)

intervention

EXPERIMENTAL

PALFIQUE universal adhesive (Tokuyama self-cure universal adhesive)

Other: universal adhesive

control

ACTIVE COMPARATOR

3M™ ESPE™ single bond Universal Adhesive

Other: universal adhesive

Interventions

universal adhesiveOTHER

PALFIQUE universal adhesive

intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Maysaa M Mostafa, B.D.S.

CONTACT

01001422220mayssaa.motafa@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant, Investigator, Outcomes assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2021

First Posted

September 23, 2021

Study Start

November 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

September 23, 2021

Record last verified: 2021-09