NCT07278180

Brief Summary

Understanding, through accurate and reliable volumetric analysis, how the biomaterial (LPRF) and the thickness of the vestibular bone plate influence changes in bone volume after extraction, is essential for making clinical decisions that impact implant-supported rehabilitation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

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

January 20, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

November 29, 2025

Last Update Submit

December 11, 2025

Conditions

Caries ActiveTooth DecayTooth Loss / Rehabilitation

Keywords

tooth lossdecaycariesbiomaterials

Outcome Measures

Primary Outcomes (2)

  • bone volume after 16 weeks

    16 weeks

  • aveolar bone contraction

    4 months

Study Arms (1)

platelet rich firbrin

Procedure: Alveolar socket preservation with graft and flap surgery

Interventions

Alveolar socket preservation with graft and flap surgeryPROCEDURE

teeth to either the control group (coagulant-filled alveoli) or the test group (alveoli filled with platelet-rich fibrin and LPRF leukocytes)

platelet rich firbrin

Eligibility Criteria

Age21 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with indication of tooth extraction

This prospective clinical study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and received approval from the Research Ethics Committee of Guarulhos University, São Paulo, Brazil (CEP-UnG #. 515.153). Thirty-nine patients (24 women and 15 men), aged between 22 and 80 years, who were in overall good health, non-diabetic, periodontally healthy, non-smokers, free of blood dyscrasias, not pregnant or lactating, and requiring extraction of non-contiguous, compromised teeth due to root fractures, caries, unsuccessful endodontic treatment, root resorption, or orthodontic reasons, were enrolled.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental CariesTooth Loss

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 11, 2025

Study Start

January 20, 2016

Primary Completion

February 20, 2018

Study Completion

January 20, 2022

Last Updated

December 18, 2025

Record last verified: 2025-12