NCT04800406

Brief Summary

Patients participating in this study were rehabilitated by mucosa supported maxillary complete denture and mandibular overdenture supported by two different surface treated implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by ball attachments. The marginal bone height changes around RBM and acid etched surface treated dental implants retaining mandibular complete overdenture were assessed by cone beam computed tomography.

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 Jan 2018

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

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 13, 2021

Last Update Submit

March 13, 2021

Conditions

Keywords

Implant surface treatmentMarginal bone heightCone beam computed tomography

Outcome Measures

Primary Outcomes (1)

  • Marginal Bone height changes

    The marginal bone changes around each type of dental implant were assessed by cone beam computed tomography.

    one year

Interventions

Resorbable blast media surface treated dental implant and Acid etched surface treated dental implant.

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Free from any systemic diseases affecting the bone metabolism.
  • Healthy, firm covering mucosa which is free from any signs of Inflammation or ulceration.
  • Residual alveolar ridge with adequate height and width.
  • Angel's class I classification maxillo - mandibular relationship.
  • Sufficient inter arch space

You may not qualify if:

  • Smoker.
  • Patients with parafunction habits (clenching or bruxism).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre

Cairo, Dokki, 12622, Egypt

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Ten completely edentulous patients aged from 50-60 years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 13, 2021

First Posted

March 16, 2021

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations