NCT06397599

Brief Summary

Introduction: the complete denture wearers mainly complain of decrease of denture retention which affects on patient's quality of life Objective: to evaluate oral health-related quality of life (OHRQoL) of denture adhesive for completely edentulous denture wearers. Material and methods : 32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 12, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
Last Updated

May 3, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

April 30, 2024

Last Update Submit

May 1, 2024

Conditions

Dental

Keywords

Denture adhesives, quality of life and OHIP-EDENT

Outcome Measures

Primary Outcomes (1)

  • patients satisfaction

    questionnaires

    6 months

Study Arms (2)

denture adhesive

ACTIVE COMPARATOR

use denture adhesive

Other: denture adhesive

non adhesive

ACTIVE COMPARATOR

conventional denture without denture adhesive

Other: denture adhesive

Interventions

denture adhesiveOTHER

use of adhesive for completely edentulous

Also known as: use of adhesive for denture
denture adhesivenon adhesive

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • completely edentulous

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11511, Egypt

Location

MeSH Terms

Interventions

Dental CementsDentures

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 3, 2024

Study Start

January 12, 2023

Primary Completion

November 9, 2023

Study Completion

December 20, 2023

Last Updated

May 3, 2024

Record last verified: 2024-04

Locations

EG(1)