NCT06632548

Brief Summary

This study was conducted on thirty patients. These patients were divided into three groups in a random manner to compare the retention forces between three different types of secondary crowns used to stabilize two implant mandibular overdentures. in all groups the primary coping was fabricated from milled titanium while the secondary coping was milled titanium in first group ,3D printed cobalt chromium in the second group and milled poly ether ketone ketone in the third group the retention forces was measured using forcemeter immediately after insertion and after 3,6, months

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
Last Updated

October 9, 2024

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

October 7, 2024

Last Update Submit

October 7, 2024

Conditions

Keywords

overdenture-telescopic attachment-poly ether ketoneketone-PEKK-milled titanium3d printed cobalt chromiumimplant retained overdenturemandibular overdenture

Outcome Measures

Primary Outcomes (1)

  • retention forces

    retention forces of three different type secondary coping telescopic attachments used to stabilize two implant mandibular overdenture these attachments are made of either milled titanium, 3D printed cobalt chromium or milled poly ether ketone ketone

    from insertion time up to one year follow up

Study Arms (3)

milled titanium secondary coping

ACTIVE COMPARATOR

group I patients received primary and secondary coping made of milled titanium

Device: telescopic overdenture

3D printed cobalt chromium secondary coping

EXPERIMENTAL

group II patients received primary coping made of milled titanium and secondary coping made of 3D printed cobalt chromium

Device: telescopic overdenture

milled poly ether ketone ketone secondary coping

EXPERIMENTAL

group III patients received primary coping made of milled titanium and secondary coping made of milled poly ether ether ketone

Device: telescopic overdenture

Interventions

two implant retained mandibular overdenture with telescopic attachment

3D printed cobalt chromium secondary copingmilled poly ether ketone ketone secondary copingmilled titanium secondary coping

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • un-satisfaction with the retention of mandibular dentures due to mandibular ridge atrophy and desired to have more stable prosthesis,
  • sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.5mm diameter implants.
  • Adequate amount of interarch space of at least 12mm from the occlusal plane of the mandibular denture to the mucosa of the ridge. Patients with the 4- age range 55 to 75 years.

You may not qualify if:

  • \) systemic and metabolic disorders that may complicate osseointegration. 2) Patients receiving bisphosphonates. 3) patients receiving radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Minia University

Elminia, Elminia, 61631, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer at prosthodontic department

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 9, 2024

Study Start

August 30, 2022

Primary Completion

January 30, 2024

Study Completion

March 30, 2024

Last Updated

October 9, 2024

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

the values of retention of each individual plus age and sex

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
starting after release of the research publication and ending after one year
Access Criteria
any researcher interested in the prosthodontics can ask for IPD will be able to ask for the participant individual data relating to their results,age,sex and planning of the case
More information

Locations