NCT06349525

Brief Summary

Forty patients ( 24female and16 male )with completely edentulous maxilla and mandible . All patients received implant supported mandibular and maxillary overdentures. The patients were randomly divided into two groups according to attachments retaining Max IOD that supported by four axial implants in maxilla . The TA was used to retain group I (GrI) MaxIOD , while that of group II (Gr II) was retained by LA. MaxIOD retention and MBL(vertical and horizontal) around implants of both groups was recorded at time of insertion (R0) ,then twelve(R12)and (R24) months following insertion of the prosthesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 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 1, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
Last Updated

April 9, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

April 1, 2024

Last Update Submit

April 7, 2024

Conditions

Jaw, Edentulous

Keywords

edentulousMaxillary implant supported overdentureRetentionMarginal bone lossLocatorTelescopic

Outcome Measures

Primary Outcomes (1)

  • Retention

    Retention was measured by a digital force gauge device (Extech's Model 475055 Digital Force Gauge FLIR Commercial Systems, Inc.) that measures tension or compression force (pull/push) to values of up to 980 Newton.25 The snap hook of the device engaged a screw fixed to the geometric center of denture bases using self-cure acrylic resin. Then pulling action was applied till the denture separation recording the amount of retention in Newton.

    1 month, 12 months, and 24 months

Secondary Outcomes (1)

  • Marginal bone loss

    12 months and 24 months

Study Arms (2)

4 implants overdenture with telescopic

EXPERIMENTAL

Completely edentulous maxillary arch treated with 4 implants overdenture

Device: telescopic overdenture

4 implant supported overdenture with Locator

ACTIVE COMPARATOR

Completely edentulous maxillary arch treated with 4 implant supported overdenture

Device: Locator overdenture

Interventions

telescopic overdentureDEVICE

Maxillary implant supported telescopic overdenture

4 implants overdenture with telescopic
Locator overdentureDEVICE

Maxillary implant supported locator overdenture

4 implant supported overdenture with Locator

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have sufficient bone volume(classes IV to VI, Cawood and Howell) and quality (classes I to III, Lekholm and Zarb)
  • be fully edentulous for at least 1 year and did not have an American Society of Anesthesiologists score (ASA) of IV or higher.
  • be with Angle Class I maxillo- mandibular relationship
  • have Adequate zone of keratinized attached mucosa \>5mm over the crest of the upper and lower ridge
  • have adequate inter-arch space (22 mm) as determined by the mounted casts carrying the patient upper and lower complete dentures .

You may not qualify if:

  • Any medical disorders that could complicate the surgical phase or affect osseointegration as osteoporosis, uncontrolled diabetes and hypertension
  • Smoking; - Former radiotherapy in the head and neck region
  • Former pre-prosthetic surgery or loss of implants in the maxilla
  • Patients with para-functional habits (as clenching or bruxism)
  • Hard tissue augmentation / grafting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta University for Science & Technology

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Jaw, EdentulousMouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth DiseasesTooth Diseases

Study Officials

  • Wafaa I Ibrahim

    Assoc. Prof.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 5, 2024

Study Start

April 1, 2021

Primary Completion

July 5, 2023

Study Completion

October 1, 2023

Last Updated

April 9, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)