NCT03684954

Brief Summary

Indirect sinus lift with used PRF as a graft material versus xenograft

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

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

First Submitted

Initial submission to the registry

September 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

September 16, 2018

Last Update Submit

September 25, 2018

Conditions

Implant or Graft; Rejection

Outcome Measures

Primary Outcomes (1)

  • Primary stability by ostell device

    Implant stability will be mesured by ostell device, implant stability will be mesured intra operative at 0 ( time of implant placement ) and 2, 4, 6, 10 and 12 weeks after surgery

    up to 3 months

Study Arms (2)

Used of PRF in clsed sinus lifting

OTHER

Used of PRF in closed sinus lifting with implant placement

Other: Prf

Closed sinus with xenograft

NO INTERVENTION

used of xenograft in closed sinus lift with implant placement.

Interventions

PrfOTHER

Take 10 cc blood from patient and gain prf

Used of PRF in clsed sinus lifting

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Edentulous area and bone high at least 5-6 mm below the maxillary sinus at maxillary premolar.
  • Good oral hygiene.

You may not qualify if:

  • bad oral hygiene.
  • patient with systemic disease that may affect normal healing
  • pregnant patients.
  • patients with bone diseases and presence of periapical pathology affecting the neighboring teeth.
  • Heavy smoker more than 20 cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
CairoU

Study Record Dates

First Submitted

September 16, 2018

First Posted

September 26, 2018

Study Start

October 1, 2018

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

September 26, 2018

Record last verified: 2018-09