Initial Clinical and CBCT Outcomes of Enamel Matrix Derivative-Based Regenerative Therapy in Vertical Bone Defects

October 10, 2024 updated by: Tsvetalina Gerova-Vatsova
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Varna, Bulgaria, 9000
        • Medical University - Varna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • smokers
  • horizontal bone loss
  • untreated periodontium disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PRP alone
Procedure: PRP( platelet rich plasma)
regenerative therapy with PRP for vertical bone defects
Active Comparator: EMD Alone
Procedure: EMD (Enamel Matrix Derivative)
regenerative therapy with EMD for vertical bone defects
Active Comparator: GTR (barrier membrane)
Procedure: Guided Tissue Regeneration (barrier membrane)
guided tissue regeneration with barrier membrane alone for vertical bone defects
Active Comparator: GTR(barrier membrane and PRP)
Procedure: Guided Tissue Regeneration(barrier membrane and PRP)
guided tissue regeneration with barrier membrane and PRP for vertical bone defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Probing depth in mm
Time Frame: 6 months
6 months
Level of Margo Gingivalis in mm
Time Frame: 6 months
6 months
Clinical attachment level in mm
Time Frame: 6 months
6 months
The distance from the ECJ to the base of the bone defect in mm
Time Frame: 6 months
6 months
The distance from the ECJ to the apex of the bone defect in mm
Time Frame: 6 months
6 months
The width of the bone defect in mm
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tsvetalina Gerova-Vatsova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2022

Primary Completion (Actual)

February 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118/23.06.22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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