NCT06109792

Brief Summary

This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

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

April 10, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

October 25, 2023

Last Update Submit

October 25, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • patient satisfaction

    patient satisfaction was recorded using score system on a scale from 0 to 100

    One year

  • oral health related quality of life

    Oral health related quality of life was evaluated by using scoring system

    one year

Study Arms (4)

• Group I

ACTIVE COMPARATOR

Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method.

Procedure: implant supported mandibular overdenture

• Group II

ACTIVE COMPARATOR

Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method.

Procedure: implant supported mandibular overdenture

Group III

ACTIVE COMPARATOR

Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method.

Procedure: implant supported mandibular overdenture

Group IV

ACTIVE COMPARATOR

Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method.

Procedure: implant supported mandibular overdenture

Interventions

In this crossover study, the patients received overdentures with two successive different pick-up techniques for the locator retentive caps; each technique was evaluated for patient satisfaction with blue and pink retentive inserts.

Group IIIGroup IV• Group I• Group II

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. All selected patients will have two implants placed in the mandibular interforaminal region.
  • \. All selected patients have a healthy mucosa and have no clinical complications.
  • \. All patients are cooperative and approve of the proposed treatment protocol

You may not qualify if:

  • \. Patients who refuse to participate in the study 2.Patients who need implant placement as a result of previous implant failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University ,Faculty of dentistry

Al Mansurah, P.O.Box:35516, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Group I: Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method. Group II: Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method. Group III: Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method. Group IV: Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

April 10, 2021

Primary Completion

June 20, 2022

Study Completion

August 16, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations