NCT05427643

Brief Summary

the main aim of the study is to evaluate the secondary implant stability when using dental implants with injectable platelet rich fibrin accompanied by non-autogenous bone graft material in narrow ridge cases versus straightforward ridges , in clinical comparative study.

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 Dec 2021

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

December 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

June 17, 2022

Last Update Submit

June 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • secondary implant stability

    measured by Anycheck device after osseointegration time

    six months

Study Arms (2)

study group

EXPERIMENTAL

patients need dental implants with narrow alveolar ridge of less than 6 mm horizontal width . they will receive dental implants with I\_PRF mixed with synthetic bone graft.

Procedure: study group

control group

EXPERIMENTAL

patients need dental implant with adequate horizontal bone with of more than 6 mm.

Procedure: control group

Interventions

study groupPROCEDURE

dental implant procedure under local anesthesia

Also known as: I-PRF preparation
study group
control groupPROCEDURE

dental implant procedure under local anesthesia

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years of age.
  • Absence of general medical contraindications for oral surgery procedures such as (Radiated jaws / uncontrolled Diabetic patient / uncontrolled hypertensive patient ).
  • Straightforward cases / narrow ridges (less than 6mm horizontal bone width) according to SAC classification ( advanced surgery ) cases.
  • Patients with reasonable oral hygiene.
  • Partially or totally edentulous alveolar ridges.

You may not qualify if:

  • Uncontrolled medically compromised patients such as : (heart diseases uncontrolled blood pressure, endocrine disorders such as (diabetes , Thyroid disorders , osteoporosis ) , immuno-compromised patient and any condition influence bone healing ……etc.
  • Heavy smokers ( ≥ 20 cigarettes a day).
  • Patients with parafunctional habits.
  • Complicated cases according to SAC classification.
  • Patient with signs of acute infection and purulent exudates at the site of implant placement as revealed by clinical and radiographical examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

college of dentistry university of Baghdad

Baghdad, Iraq

Location

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

June 17, 2022

First Posted

June 22, 2022

Study Start

December 15, 2021

Primary Completion

March 1, 2023

Study Completion

May 1, 2023

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations