NCT04763187

Brief Summary

Healing of post-extraction alveolus is a complex process that involves soft and hard tissues regeneration. Pain, swelling, difficulty of opening the mouth, delayed healing of bone tissue, alveolitis and horizontal or vertical resorption of bone tissue are the main problems that have impact on consequent treatment. Blood concentrates PRGF (plasma rich in growth factors) and PRF (platelet-rich fibrin), which are rich in growth factors, create better conditions for post-extraction alveolus healing and enhance quality of soft tissues and bone regeneration. Our study objective was to compare physiological healing of post-extraction zone, PRF and PRGF induced changes of healing process. Methods that we used: 43 patients were randomly divided into 3 groups: I control group - lower molar extraction and filling of post-extraction alveolus with hemostatic sponge containing gentamicin, II group - post-extraction alveolus is filled PRGF and III group - post-extraction alveolus is filled with PRF. Bone regeneration was evaluated in CBCT scans after 1 month. Pain was evaluated using visual analogical scale (VAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 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

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 16, 2021

Last Update Submit

February 17, 2021

Conditions

Chronic Periodontitis ApicalEmbedded Tooth

Outcome Measures

Primary Outcomes (4)

  • Post operative pain

    Pain was evaluated using visual analogical scale (VAS). Pacients selected number from 0 to 10, there accordingly 0 - no pain, 5 - moderate pain and 10 - worst pain.

    First day after surgery.

  • Post operative pain

    Pain was evaluated using visual analogical scale (VAS). Pacients selected number from 0 to 10, there accordingly 0 - no pain, 5 - moderate pain and 10 - worst pain.

    Seventh day after surgery.

  • Bone regeneration

    Bone regeneration was evaluated in CBCT scans. In CBCT scans (Ez3D Plus Professional Ver.1.2.6.1) immediately after surgery horizontal (mm) and vertical (mm) dimensions of alveolar ridge were measured.

    Immediately after surgery.

  • Bone regeneration

    Bone regeneration was evaluated in CBCT scans. In CBCT scans (Ez3D Plus Professional Ver.1.2.6.1) 1 month after surgery horizontal (mm) and vertical (mm) dimensions of alveolar ridge were measured. Also, horizontal (mm), vertical (mm) and diagonal (mm) dimensions of primary bone tissue formed in post-extraction alveolus in 1 month.

    1 month after surgery.

Study Arms (3)

Control group

ACTIVE COMPARATOR

Lower molar extraction and filling of post-extraction alveolus with hemostatic sponge containing gentamicin.

Procedure: Tooth extraction

PRGF group

EXPERIMENTAL

Post-extraction alveolus is filled with PRGF.

Procedure: Tooth extraction

PRF group

EXPERIMENTAL

Post-extraction alveolus is filled with PRF.

Procedure: Tooth extraction

Interventions

Tooth extractionPROCEDURE

Tooth extraction and alveolus regeneration with autologous blood concentrate.

Control groupPRF groupPRGF group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who need lower molar extraction
  • Patients who belong to working age group (18-50 years)

You may not qualify if:

  • Pregnant women and postmenopausal women
  • Children and older than 50 years old patients
  • Oncological diseases, undergone chemotherapy and radiation therapy
  • Chronic diseases
  • Hormonal imbalances
  • Somatic symptom disorder
  • Osteoporosis, osteonecrosis
  • Taking bisphosphonates, antidepressants, psychotropic drugs
  • Smoking
  • Psychologically dissabled patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Jan Pavel Rokicki

    Oral surgeon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 21, 2021

Study Start

September 1, 2019

Primary Completion

December 29, 2019

Study Completion

January 29, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)