NCT05797675

Brief Summary

12 patients with indirect sinus lift will be selected with RBH\>5mm , surgical procedure =osseodensification + Prf+ implant .

  1. 1.versah drilling system (osseodensefication technique )will be used , moreover Prf will be prepared by Blood collected in PRF tubes from patients then centrifuge (1300rpm ,14min ) .
  2. 2.primary stability will be measured using Resonance Frequency Analysis by Osstellimmediately and after 6 Mn .
  3. 3.CBCT will be taken before surgery , perioapical x-ray immediately after surgery and CBCT at 6m follow up to be apple to see the differences regarding bone quality and volume.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

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

Study Start

First participant enrolled

July 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

March 22, 2023

Last Update Submit

April 9, 2023

Conditions

Oral Sinus

Outcome Measures

Primary Outcomes (2)

  • secondary stability of implant

    by osstel

    6 months

  • bone density

    measuring and evaluating bone density by cbct

    6 months

Study Arms (1)

Test group

EXPERIMENTAL

Implant therapy and closed sinus lifting with A-PRF

Procedure: prf + osseodensification

Interventions

prf + osseodensificationPROCEDURE

prf+ osseodensification in close sinus lift

Also known as: platelet concentrates,
Test group

Eligibility Criteria

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

You may qualify if:

  • \- medically fit non pregnant no sinus pathology

You may not qualify if:

  • young patients under 18
  • sinus pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadeel Albahar

Nablus, Palestinian Territories

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • hadeel albahar, master

    Arab American University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 4, 2023

Study Start

July 20, 2022

Primary Completion

November 20, 2022

Study Completion

December 30, 2022

Last Updated

April 11, 2023

Record last verified: 2023-04

Locations

PA(1)