NCT03184883

Brief Summary

comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue and patient's satisfaction

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
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

June 1, 2017

Enrollment Period

1 month

First QC Date

June 2, 2017

Last Update Submit

July 19, 2017

Conditions

Health Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (1)

  • Cytological changes manifested as keratinization index

    Objective Outcome: measuring the cytological changes manifested as keratinization index

    6 months

Study Arms (2)

single conventional denture

EXPERIMENTAL

patients with mandibular edentulous arch by using acrylic resin denture with soft linner

Procedure: single conventional denture

single flexible denture

ACTIVE COMPARATOR

patients with mandibular edentulous arch by using flexible lower denture

Procedure: single flexible denture

Interventions

single conventional denturePROCEDURE

mandibular conventional denture with soft liner

single conventional denture
single flexible denturePROCEDURE

mandibular flexible compete denture

single flexible denture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mandibular flat ridge
  • Patient with opposing natural teeth or satisfactory fixed prostheses
  • Angle class I Maxillimandibular relationship
  • No intraoral soft and hard tissue pathosis
  • Non smokers
  • Patients with no previous denture experience
  • Patients having last extraction at least 6 month before denture construction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behavior

Study Officials

  • Essam Aziz, professor

    supervisor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Azer, Bachelor

CONTACT

01227243531marianne.fouad@dentistry.cu.edu.eg

Ahmed Fayad, lecturer

CONTACT

01005185211

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comparative Study of Conventional versus Flexible Mandibular Single Complete Denture

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 14, 2017

Study Start

September 1, 2017

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share