NCT04686370

Brief Summary

The research will be conducted to report which type of surface treatment of dental implants that can be successful and aids in increasing bone to implant contact and how it affects the bony changes around the implants installed in mandibular arches for completely edentulous patients or whether there are specific precautions to be taken into consideration during implant planning concerned with the type of surface microstructure treatment and recommendations needed.

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
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

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

October 6, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

November 25, 2020

Last Update Submit

December 22, 2020

Conditions

Keywords

Dental implantSurface treatmentLaserSandblasted Acid-etched implantsDelayed-loadingBony changesMarginal bone loss

Outcome Measures

Primary Outcomes (1)

  • Marginal bone stability around dental implants

    Measuring amount of marginal bone loss by radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)

    1 year

Study Arms (2)

sandblasted acid-etched implants

ACTIVE COMPARATOR

implant will be installed intraforaminal

Other: laser treated implant surface

laser treated implants

EXPERIMENTAL

implant will be installed intraforaminal

Other: laser treated implant surface

Interventions

Better marginal bone stability is expected for this type

laser treated implantssandblasted acid-etched implants

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Completely edentulous patients
  • Angle's class 1 skeletal relationship
  • Normal facial asymmetry
  • Cooperative patients
  • Adequate inter-arch spcae not less than 12mm

You may not qualify if:

  • Tempromandibular joint disorder
  • Uncontrolled diabetes
  • Bleeding disorders or anticoagulant therapy
  • Flabby tissues or sharp mandibular residual ridge
  • Heavy smoker
  • Patient's with neuromuscular disorders
  • Patients on chemotherapy or radiotherapy
  • Severe psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry,cairo university

Cairo, Egypt

Location

Study Officials

  • Marwan Mohamed, Investigator

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: one single group will receive both types of dental implants (Split-mouth)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 28, 2020

Study Start

October 6, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

December 28, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations