Plasma Rich in Growth Factors in the Preservation of the... | NCT04945629

Studies
Plasma Rich in Growth Factors in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.

NCT04945629

Sponsor

Fundación Eduardo Anitua

Status

Completed

Last Update Posted

Feb 25, 2025Actual

Enrollment

44Actual

Phase

Phase 3

Conditions

Dental Implantation

Interventions

Alveolar ridge preservation with a PRP (PRGF-Endoret)
Blood clot and simple suture

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Sep 2, 2020Actual

Primary Completion Date

Jan 31, 2025Actual

Completion Date

Jan 31, 2025Actual

First Submitted Date

Jun 15, 2021

First Submission Date that Met QC Criteria

Jun 22, 2021

First Posted Date

Jun 30, 2021Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This Randomized Clinical Trial aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation after single molar extractions. 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

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simple suture	Active Comparator	Atraumatic exodontia followed by simple suture	Drug: Blood clot and simple suture
PRGF-Endoret	Experimental	Atraumatic exodontia followed by simple suture	Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alveolar ridge preservation with a PRP (PRGF-Endoret)	Drug	Filling of the alveolus with PRGF clot and fibrin plug.	PRGF-Endoret

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone regeneration	Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation	12 weeks post-extraction

Secondary Outcomes

Measure	Description	Time Frame
Visual Analogue Score (VAS)	Evolution of pain assessed by the visual analog scale (VAS). Values ranging 0 to 10 (0=no pain and 10=worst pain)	3, 7 and 15 days post-extraction
Inflammation score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age> 18 years
Clinical indication for simple tooth extraction in the posterior sectors (from the second premolar to upper and lower second molars)
Need to place a dental implant in the same position of the extraction
Availability of observation during the period of treatment
Signature of the informed consent

Exclusion Criteria:

Third molars
Active periodontal disease
Simultaneous extraction of two adjacent pieces in the same quadrant
Oral dehiscence ≥ 25%
Alveolus depth <7mm
Loss of some wall of the alveolus
Severe inflammation in the extraction area
Previous diagnosis of coagulopathies
Previous diagnosis of autoimmune disease
Be receiving, or have received the 30 days prior to extraction treatment with radiotherapy, chemotherapy, immunosuppressants, systemic corticosteroids or anticoagulants
Regular treatment with NSAIDs
History of chronic hepatitis or liver cirrhosis
Positive markers for HCV, AfHBs, HIV-I / II or TP
Diabetes mellitus with poor metabolic control (evidence of glycated hemoglobin> 9%)
Dialysis treatment
Presence of malignant tumors, hemangiomas or angioma in the extraction area.
History of ischemic heart disease in the last year
Pregnancy or women of childbearing age who do not take action contraceptives
Lactating women
Previous diagnosis of metabolic bone disease
Antiresorptive treatment
Treatment with monoclonal antibodies
Smoker> 10 cigarettes / day
Any inability 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

ID	Term
D006487	Hemostasis
D001790	Blood Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena