NCT05910333

Brief Summary

. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

June 9, 2023

Last Update Submit

October 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Posterior mandibular ridge resorption (PMandRR)

    The amount of PMandRR will be assessed using posterior area index on a panoramic x-ray which use specific landmarkds.

    10 years retrospective study

Secondary Outcomes (1)

  • Anterior maxillary ridge resorption (AMaxRR)

    10 years

Other Outcomes (1)

  • Crestal bone loss around implants

    10 years

Study Arms (2)

Quadrilateral distribution group

Patients with quadrilateral distribution of implants

Other: observation

Linear distribution group

Patients with lineardistribution of implants

Other: observation

Interventions

To compare the effect of the mandibular implant retained OVD using quadrilateral distribution (QD) versus linear distribution (LD) on posterior mandibular ridge resorption (PMandRR), anterior maxillary ridge resorption (AMaxRR), and changes to the crestal bone level around implants after 10 years of function.

Linear distribution groupQuadrilateral distribution group

Eligibility Criteria

Age55 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsabove 60
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

10 patients in each group. total number of patients 20.

You may qualify if:

  • Patients with 4 implants in the inter-foraminal region.
  • Patients treated by staff and students in the Master's program in Prosthodontics Department according to the following criteria:
  • Edentulous maxilla and mandible for at least 1 year.
  • Problems with retention and stability of the mandibular denture.
  • Mandibular bone height between 15 and 25 mm.

You may not qualify if:

  • Patients with relative contraindications, such as
  • A history of para functional habits.
  • Smokers more than 10 cigarettes per day.
  • alcoholism.
  • Patients with a history of radiation therapy in the head and neck region . • Patients within intravenous administrated bisphosphonates., chemotherapy, and mental disorders that could jeopardies their co-operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed El Sawy

Multiple Locations, 12345, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Resorption

Interventions

Observation

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Mohammed E Sawy

    Mansoura University

    STUDY DIRECTOR

Central Study Contacts

Mohammed E Sawy, PhD

CONTACT

Salah A. Hegazy, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer, Department of prosthodontics, principle investigator

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 18, 2023

Study Start

March 28, 2023

Primary Completion

October 21, 2023

Study Completion

October 27, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

just by contacting the corresponding author

Locations