Plasma Rich in Growth Factors (PRGF-Endoret) in the Regeneration of Post-Extraction Sockets

NCT01465399 | Completed

• 2 other identifiers: FIBEA-01-EC/11/ALV2019-001167-75
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Immediately following tooth removal, a healing process begins that affects the eventual alveolar bone volume and architecture of the alveolar ridge. Satisfactory and timely healing are essential to obtain ideal functional reconstruction. Traumatic removal of a tooth, or a poor healing response, may lead to excessive bone loss delaying tooth replacement, requiring expensive and time-consuming reconstructive surgeries, or even the inability to be corrected. The Plasma Rich in Growth Factors (PRGF-Endoret) has shown its therapeutic potential effect to minimize the consequences of this aggression, promoting the regeneration of both hard and soft involved tissues.

Conditions

Post-Extraction Sockets Healing

Outcome Measures

Primary Outcomes (1)

• Percentage of regenerated post-extraction sockets

  10-12 weeks

Secondary Outcomes (5)

• Regenerated bone volume

  10-12 weeks

• Post-operative pain (VAS)

  3, 7 and 15 days post-extraction

• Soft Tissue Healing Index

  3, 7 and 15 days post-extraction

• Inflammation

  3, 7 and 15 days post-extraction

• Adverse events or complications

  10-12 weeks

Study Arms (2)

PRGF-Endoret

EXPERIMENTAL

Biological: Plasma Rich in Growth Factors PRGF-Endoret

Conventional treatment

ACTIVE COMPARATOR

Procedure: Conventional closure of the lesion

Interventions

Plasma Rich in Growth Factors PRGF-Endoret BIOLOGICAL

PRGF-Endoret

Conventional closure of the lesion PROCEDURE

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects of both genders and ≥ 18 years old
• Indication of a simple one molar extraction in the mandible.
• Possibility of observation during the follow-up period.

You may not qualify if:

• Unerupted third molars or with horizontal inclination.
• Severe swelling prior to surgery in the areas designated for extraction.
• Suffering an alteration or a serious hematologic disease.
• In regular treatment with NSAIDs or other anti-inflammatory drugs.
• History of chronic hepatitis or cirrhosis.
• Diabetes mellitus with poor metabolic control (glycosylated hemoglobin \>9%)
• Patients undergoing dialysis.
• Presence of malignant tumors, hemangiomas or angiomas in the extraction area.
• History of ischemic heart disease in the last year.
• Pregnancy or planned pregnancy during the study follow-up period.
• Metabolic Bone Disease.
• Patients taking bisphosphonates both orally and intravenously.
• In general, any inability to participate in the study.

Sponsors & Collaborators

• Fundación Eduardo Anitua: lead

Study Sites (1)

Clínica Dental Eduardo Anitua

Vitoria-Gasteiz, Spain

Location

Study Officials

• Eduardo Anitua, MD, DDS, PhD

  Clinica Dental Eduardo Anitua

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 4, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

ES (1)