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Clinical Trials/NCT04980066
NCT04980066UnknownNot Applicable

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

Kafrelsheikh University1 site in 1 country20 target enrollmentStarted: August 3, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
clinical evaluation of root coverage

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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 <
  • •Non-smokers.

Exclusion Criteria

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

Arms & Interventions

sticky bone and EDTA

Experimental

treatment of gingival recession using sticky bone after root surface biomodification with EDTA

Intervention: Sticky bone and EDTA (Procedure)

Sticky bone

Active Comparator

treatment of gingival recession using sticky bone

Intervention: Sticky bone (Procedure)

Outcomes

Primary Outcomes

clinical evaluation of root coverage

Time Frame: 6 months

the percentage of root coverage will be calculated in millimeter

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dalia Rasheed Issa

principal invistigator

Kafrelsheikh University

Study Sites (1)

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