NCT06639555

Brief Summary

Study of the effectiveness of the application of regenerative therapy with autogenous, platelet-rich plasma in vertical defects Investigation of the effectiveness of the application of regenerative therapy with enamel matrix derivatives in vertical bone defects Study of the effectiveness of the application of guided tissue regeneration in vertical bone defects with Barrier membrane and Barrier membrane and autogenous platelet-rich plasma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

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

June 24, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 9, 2024

Last Update Submit

October 10, 2024

Conditions

Vertical Alveolar Bone Loss

Outcome Measures

Primary Outcomes (6)

  • Probing depth in mm

    6 months

  • Level of Margo Gingivalis in mm

    6 months

  • Clinical attachment level in mm

    6 months

  • The distance from the ECJ to the base of the bone defect in mm

    6 months

  • The distance from the ECJ to the apex of the bone defect in mm

    6 months

  • The width of the bone defect in mm

    6 months

Study Arms (4)

PRP alone

ACTIVE COMPARATOR
Procedure: PRP( platelet rich plasma)

EMD Alone

ACTIVE COMPARATOR
Procedure: EMD (Enamel Matrix Derivative)

GTR (barrier membrane)

ACTIVE COMPARATOR
Procedure: Guided Tissue Regeneration (barrier membrane)

GTR(barrier membrane and PRP)

ACTIVE COMPARATOR
Procedure: Guided Tissue Regeneration(barrier membrane and PRP)

Interventions

PRP( platelet rich plasma)PROCEDURE

regenerative therapy with PRP for vertical bone defects

PRP alone
EMD (Enamel Matrix Derivative)PROCEDURE

regenerative therapy with EMD for vertical bone defects

EMD Alone
Guided Tissue Regeneration (barrier membrane)PROCEDURE

guided tissue regeneration with barrier membrane alone for vertical bone defects

GTR (barrier membrane)
Guided Tissue Regeneration(barrier membrane and PRP)PROCEDURE

guided tissue regeneration with barrier membrane and PRP for vertical bone defects

GTR(barrier membrane and PRP)

Eligibility Criteria

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

You may qualify if:

  • good oral hygiene
  • written informed consent
  • age
  • no systemic diseases

You may not qualify if:

  • smokers
  • horizontal bone loss
  • untreated periodontium disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University - Varna

Varna, Varna, 9000, Bulgaria

Location

MeSH Terms

Interventions

emerinGuided Tissue Regeneration

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

June 24, 2022

Primary Completion

February 15, 2023

Study Completion

August 15, 2023

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations

BU(1)