NCT03943680

Brief Summary

The purpose of this study is to compare the clinical success, radiographical volume maintenance and histological bone regeneration after using either a bovine bone xenograft or an autogenous platelet rich plasma enrich in growth factors, known as Endoret®-PRGF®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

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

March 4, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

5.7 years

First QC Date

May 7, 2019

Last Update Submit

May 9, 2026

Conditions

Keywords

Tooth extractionSocket regenerationDental Implants

Outcome Measures

Primary Outcomes (1)

  • Alveolar bone change in Cone Beam Computerized Tomography

    Volumetric change in the alveolar bone from immediately after tooth extraction to immediately before implant placement (4 months after the extraction and grafting of the socket)

    Baseline and 4 months

Study Arms (2)

PRGF

EXPERIMENTAL

Post-extraction socket grafted with PRGF-Endoret

Device: PRGF

ABB

ACTIVE COMPARATOR

Post-extraction socket grafted with anorganic bovine bone (ABB)

Device: ABB

Interventions

PRGFDEVICE

After tooth extraction, the socket will be grafted with PRGF-Endoret

Also known as: PRGF-Endoret
PRGF
ABBDEVICE

After tooth extraction, the socket will be grafted with Geistlich Bio-Oss® Collagen

Also known as: Geistlich Bio-Oss® Collagen
ABB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Upper or lower premolar or molar tooth in need of extraction and later restoration by dental implant.
  • Adjacent and opposing natural teeth present and healthy.
  • At least 3 mm from the tip of the dental root to the maxillary sinus or the inferior alveolar canal.

You may not qualify if:

  • Active local infection.
  • Uncontrolled diabetes mellitus.
  • Long term (\>10 years) use of oral bisphosphonates.
  • Use of intravenous bisphosphonates.
  • Recent use (\<3 months) of antibiotics, antiinflammatories or analgesics drugs.
  • Pregnancy.
  • Smokers of more than 10 cigarettes per day.
  • Any oral pathology that needs to be treated before tooth extraction, particularly the presence of more than 25% of sites with bleeding on probing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Odontología

Granada, Granada, 18071, Spain

Location

Related Publications (1)

  • Anitua E, Murias-Freijo A, Alkhraisat MH, Orive G. Clinical, radiographical, and histological outcomes of plasma rich in growth factors in extraction socket: a randomized controlled clinical trial. Clin Oral Investig. 2015 Apr;19(3):589-600. doi: 10.1007/s00784-014-1278-2. Epub 2014 Jul 8.

    PMID: 24998770BACKGROUND

Study Officials

  • Pablo Galindo-Moreno, DDS, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

March 4, 2019

Primary Completion

November 18, 2024

Study Completion

October 30, 2025

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations