NCT05936775

Brief Summary

the purpose of this trial is to evaluate the osseointegration properties of nano-hydroxy apatite coated titanium implants in posterior maxilla. 30 patients will be included in this trial divided into two groups, control and intervention. Primary and secondary implant stability will be measured

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 Jun 2023

Shorter than P25 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

First Submitted

Initial submission to the registry

June 22, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

June 22, 2023

Last Update Submit

April 8, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Implant stability

    implant stability will be measured by radiofrequency analysis

    immediately post-operative

  • Implant stability

    implant stability will be measured by radiofrequency analysis

    4 weeks post-operative

  • Implant stability

    implant stability will be measured by radiofrequency analysis

    6 weeks post-operative

  • Implant stability

    implant stability will be measured by radiofrequency analysis

    12 weeks post-operative

Study Arms (2)

Nano-hydroxy apatite arm

EXPERIMENTAL

in this groups patients will receive nano-hydroxy apatite coated titanium implants

Other: nano-hydroxy apatite coated titanium implants

SLA arm

ACTIVE COMPARATOR

in this group patients will receive sandblasted large thread acid etched titanium implants

Other: sandblasted large acid itched coated titanium implant

Interventions

titanium implants with surface treatment of nano-hydroxy apatite

Nano-hydroxy apatite arm

titanium implants with SLA surface treatment

SLA arm

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with missing at least one maxillary posterior tooth
  • Patients free from any systemic disease
  • Patients who approve to be included in the trial and sign the informed consent
  • Patients with no intra-bony defect.
  • Adults aged 18 years old and above

You may not qualify if:

  • Patients who are allergic to titanium
  • Heavy smoker patient
  • Patients receiving chemotherapy or radiotherapy
  • Patients who refused to be included in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October University for Modern Sciences and Arts faulty of Dentistry

Giza, Egypt

Location

Study Officials

  • Mohamed H Mahmoud, PhD

    october university for modern science and arts faculty of dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 10, 2023

Study Start

June 22, 2023

Primary Completion

April 1, 2024

Study Completion

April 5, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations