Socket Augmentation Using Atorvastatin With Or Without PRGF (Clinical and Histomorphometric Study)

NCT03228771 | Completed Phase 4 DMC

• 1 other identifier: FDASU-RECM041515
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.

Conditions

Socket Preservation

Keywords

PRGF; Statins; socket augmentation

Outcome Measures

Primary Outcomes (1)

• clinical measurements Ridge width

  Ridge width

  1 year

Secondary Outcomes (1)

• clinical measurements ridge height

  1 year

Other Outcomes (1)

• histomorphometric analysis

  1 year

Study Arms (3)

PRGF/ATV

ACTIVE COMPARATOR

Group I (PRGF/ATV) : It was included 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin loaded in PRGF derived fibrin scaffold then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis. Intervention: Atorvastatin drug loaded in platelets rich in growth factors (PRGF).

Drug: PRGF/ATV

ATV gel

ACTIVE COMPARATOR

Group II (ATV gel) : Will include 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin in methyl cellulose gel then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.

Drug: ATV gel

Empty socket

NO INTERVENTION

Group III Empty socket( control) : Will include 10 patients undergoing single tooth extraction then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.

Interventions

PRGF/ATV DRUG

Atorvastatin loaded in PRGF fibrin scaffold

Also known as: platelets rich in growth factors

PRGF/ATV

ATV gel DRUG

Atorvastatin loaded in methyl cellulose gel

Also known as: Atorvastatin gel

ATV gel

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
• Both sexes.
• Age from 20 - 50 years old.
• Having at least one hopeless tooth indicated for extraction.
• Patient should agree to sign a written consent after the nature of the study will be explained.

You may not qualify if:

• Smokers.
• Pregnant and breast feeding females.
• Prisoners and handicapped patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry-Ain shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Intercellular Signaling Peptides and Proteins

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Khaled A Ghaffar, Professor

  Ain Shams University

  STUDY DIRECTOR

• Ola M Ezzatt, Lecturer

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 3 Groups: Group 1: statin loaded in PRGF Group 2: statin loaded in methylcellulose gel Group 3: control

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: July 25, 2017
• Study Start: March 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: August 15, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

EG (1)