Denture Adhesive is a Patient Advantageous or Prosthetic Failure During Adaption Period: Randomized Control

NCT ID: NCT06397599

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2023-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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denture adhesive

use denture adhesive

Group Type ACTIVE_COMPARATOR

denture adhesive

Intervention Type OTHER

use of adhesive for completely edentulous

non adhesive

conventional denture without denture adhesive

Group Type ACTIVE_COMPARATOR

denture adhesive

Intervention Type OTHER

use of adhesive for completely edentulous

Interventions

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denture adhesive

use of adhesive for completely edentulous

Intervention Type OTHER

Other Intervention Names

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use of adhesive for denture

Eligibility Criteria

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Inclusion Criteria

* completely edentulous

Exclusion Criteria

* no
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sharaf Mohamed Yahia

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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asharaf Email

Identifier Type: OTHER

Identifier Source: secondary_id

6785/5

Identifier Type: -

Identifier Source: org_study_id

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