Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination

NCT03231137 | Completed Phase 4 DMC

• 1 other identifier: ASU-OMP-2012-9
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted to compare post-extraction augmented sockets using Atorvastatin loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and spontaneously healed socket (Control) both clinically and by histomorphometric analysis of formed bone quality.

Conditions

Alveolar Socket Preservations

Outcome Measures

Primary Outcomes (2)

• Relative ridge height

  (Measured from stent reference point to the crest of the buccal or palatal plate of bone)

  baseline (immediately after extraction) - After 2 months

• Ridge width

  (Measured from the buccal to palatal plate of bone using bone caliper)

  baseline (immediately after extraction) - After 2 months

Secondary Outcomes (2)

• Collagen surface area

  after 2 months

• Average tabecular size

  after 2 months

Study Arms (5)

PRGF/ATV

EXPERIMENTAL

Included 10 patients undergoing single tooth extraction and platelet rich in growth factors fibrin scaffold loaded with Atorvastatin powder (PRGF/ATV) were placed to fill the extraction socket.

Combination Product: PRGF/ATV

ATV gel

EXPERIMENTAL

Included 10 patients undergoing single tooth extraction and Atorvastatin gel were placed to fill the extraction socket.

Drug: ATV gel

PRF

EXPERIMENTAL

Included 10 patients undergoing single tooth extraction and platelet rich fibrin (PRF) were placed to fill the extraction socket.

Biological: PRF

PRGF

EXPERIMENTAL

Included 10 patients undergoing single tooth extraction and plasma rich in growth factors (PRGF) were placed to fill the extraction socket.

Biological: PRGF

Control

NO INTERVENTION

Spontaneously healed socket

Interventions

PRGF/ATV COMBINATION_PRODUCT

Atorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold

PRGF/ATV

ATV gel DRUG

Atorvastatin gel

ATV gel

PRF BIOLOGICAL

Platelet rich fibrin

PRF

PRGF BIOLOGICAL

plasma rich in growth factor

PRGF

Eligibility Criteria

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

You may qualify if:

• \. Both genders, aged from 20 to 50 years
• \. Patients free from any systemic diseases
• \. Hopeless teeth indicated for extraction (badly decayed tooth, tooth contraindicated for crown preparation such as tooth with subgingival caries, broken roots, periodontally affected teeth, remaining roots) in the premolar and first molar area.
• \. Socket type I: The facial soft tissue and buccal plate of bone are at normal levels in relation to cement-enamel junction of the pre-extracted tooth and remain intact postextraction as determined by clinical examination and periapical radiographs
• \. Patient agreed to sign a written consent after explanation of study nature.

You may not qualify if:

• \. Smokers.
• \. Pregnant and breast feeding females.
• \. Previous radiation, chemotherapy, or immunosuppressive treatments.
• \. Known hypersensitivity to statin drugs.
• \. Teeth with periapical infections, type II or III sockets or with dehiscence or fenestrations
• \. Vulnerable groups such as (Prisoners and handicapped or mentally disabled)

Sponsors & Collaborators

• Ain Shams University: lead

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: Lecturer Dr.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: June 16, 2012
• Primary Completion: March 12, 2017
• Study Completion: July 10, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07