Randomized Clinical Trial, Conventional Treatment-control... | NCT04093583

Studies
Randomized Clinical Trial, Conventional Treatment-controlled, Studying the Efficacy of Plasma Rich in Growth Factor (PRGF®) in Alveolar Ridge Preservation After Simple Exodontia in the Anterior Region of Maxilla.

NCT04093583

Sponsor

Fundación Eduardo Anitua

Status

Completed

Last Update Posted

Feb 25, 2025Actual

Enrollment

46Actual

Phase

Phase 3

Conditions

Dental Implantation

Interventions

Exodontia
Alveolar ridge preservation with a PRP (PRGF-Endoret)
Preparation of PRGF using Endoret technology

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2019-001167-75	EudraCT Number

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2019Actual

Primary Completion Date

Jan 29, 2025Actual

Completion Date

Jan 29, 2025Actual

First Submitted Date

Sep 16, 2019

First Submission Date that Met QC Criteria

Sep 16, 2019

First Posted Date

Sep 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2025

Last Update Posted Date

Feb 25, 2025Actual

Description Module

Brief Summary

This RCT aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation in the aesthetic zone. The control group is the spontaneous healing occuring after the suturing of the alveolus. The primary endpoint is the bone regeneration measured in biopsies obtained from the regenerated alveolar bone.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simple suture	Active Comparator		Procedure: Exodontia
PRGF-Endoret	Experimental		Procedure: Exodontia Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret) Device: Preparation of PRGF using Endoret technology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exodontia	Procedure	Atraumatic exodontia followed by simple suture	PRGF-Endoret Simple suture

Measure	Description	Time Frame
Bone regeneration	Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Subjects of both sexes with an age greater than or equal to 18 years.
Clinical indication for a simple exodontia in the aesthetic zone (from left 2nd premolar to the right 2nd premolar in the maxilla).
Need of a dental implant placement in the extraction site.
Availability to follow-up during the treatment period
Subjects with non-active periodontal disease.
Buccal dehiscence < than 25% in the vestibular table

Exclusion Criteria:

- Presence of an active infection
Loss of any plate of the socket
Severe inflammation in the area of the exodontia previous to the intervention
Have previous diagnosis of a coagulopathy.
Have previous diagnosis of any autoinmune disease.
Have received radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to inclusion
Regular treatment with AINES or other antiinflammatory drugs
Previous history of chronic hepatitis or heatic cirrhosis
Positive markers for VHC, AgHBs, VIH I/II or Treponema pallidum
Uncontrolled diabetes mellitus (Glycosylated hemoglobin higher than 9%)
Subjects submitted to hemodyalisis
Presence of malignant tumour, haemangiomas or angioma in the exodontia region.
Previous history of ischemic cardiopathy in the last year.
Pregnancy or womens in childbearing age who do not take contraception measures.
Nursing womens
Metabolic bone disease
Ongoing treatment with biphosphonates both through oral or intravenous administration
Smoking habits (> 10 cigarrettes/day)
In general, any disability to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Eduardo Anitua Private Clinic		Vitoria-Gasteiz	Alava	01005	Spain
Clinica dental Murias

ID	Term
D019647	Oral Surgical Procedures
D013514	Surgical Procedures, Operative
D003813	Dentistry