Evaluation of Sticky Bone With or Without EDTA for Treatment of Gingival Recession

April 9, 2024 updated by: Dalia Rasheed Issa, Kafrelsheikh University

Evaluation of Sticky Bone With or Without EDTA Root Surface Biomodification for Treatment of Gingival Recession: Randomized Controlled Clinical Study

Gingival recession is a common clinical finding in periodontal disease which is frequently associated with esthetic concerns, root hypersensitivity, and root caries. Many surgical therapeutic approaches have been developed to predictably obtain root coverage of gingival recession defects. Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent obtained by low-speed centrifugation, and it has the capacity to stimulate tissue regeneration. At high concentrations, PRF may stimulate the secretion of several growth factors and trigger fibroblast migration. I-PRF is generally used in regenerative treatments, with good outcomes. Ethylenediaminetetraaceti acid (EDTA) is a chelating agent that could enhance the attachment of connective tissue to the root surface by exposing collagen and, as a consequence, enhance root coverage. EDTA works at neutral pH, and this property has been reported to preserve adjacent tissue vitality. The present study will be carried out to evaluate the effect of sticky bone with or without EDTA root surface biomodification for treatment of gingival recession.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Locations

  • Egypt
      • Kafr El-sheikh, Egypt, 33511
        • Recruiting
        • faculty of dentistry, kafrelsheikh University
        • Contact:

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Miller I/II isolated maxillary recession defects.
  • No abrasion, caries, or cervical restorations and presence of identifiable cementoenamel junction (CEJ).
  • No occlusal interferences.
  • Full-mouth plaque index (PI) and gingival index (GI) scores of < 1.
  • Non-smokers.

Exclusion Criteria:

  • Pregnant patients
  • Presence of systemic disease or taking medication that interfere with periodontium

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sticky bone and EDTA
treatment of gingival recession using sticky bone after root surface biomodification with EDTA
Procedure: Sticky bone and EDTA
treatment using Sticky bone after EDTA root surface biomodification
Active Comparator: Sticky bone
treatment of gingival recession using sticky bone
Procedure: Sticky bone
treatment using Sticky bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical evaluation of root coverage
Time Frame: 6 months
the percentage of root coverage will be calculated in millimeter
6 months

Collaborators and Investigators

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

Sponsor

Kafrelsheikh University

Investigators

  • Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University

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)

August 3, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

July 17, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD/10/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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