NCT06016218

Brief Summary

This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not. This will be done through:

  1. 1.Measuring bone changes around the implant by cone beam
  2. 2.Measuring change in bone density around the implants

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2021

Typical duration for phase_1

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

January 5, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

June 12, 2023

Last Update Submit

September 1, 2023

Conditions

Dental Caries Extending to PulpDental Implant Failed

Outcome Measures

Primary Outcomes (1)

  • Changes in crestal peri-imlant Bone

    Radiographic evaluation of crestal bone changes around the studied implants

    12 months

Study Arms (3)

PRF

PLACEBO COMPARATOR

PRF alone was added to extraction site prior to implant insertion

Drug: Simvastatin

SIM+ PRF

ACTIVE COMPARATOR

PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion

Drug: Simvastatin

BO+ PRF

ACTIVE COMPARATOR

PRF + Bone powder are inserted into the extraction site before implant insertion.

Drug: Simvastatin

Interventions

SimvastatinDRUG

Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone

BO+ PRFPRFSIM+ PRF

Eligibility Criteria

Age45 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Badly Broken Down Tooth requiring extraction
  • Medically Free
  • Any other procedures or surgeries were performed 6 months earlier

You may not qualify if:

  • patients with systemic diseases affecting bone quality or resorption
  • temporomandibular joint dysfunction
  • severe attrition or parafunctional habits
  • patients undergoing radiotherapy or chemotherapy
  • heavy smokers
  • vulnerable groups like psychologically unstable patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The British University in Egypt

Cairo, Egypt

Location

MeSH Terms

Interventions

Simvastatin

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

August 29, 2023

Study Start

January 5, 2021

Primary Completion

January 5, 2022

Study Completion

February 5, 2023

Last Updated

September 6, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)