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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04980066
• Other study ID #: KD/10/21
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Kafrelsheikh University
• Contact: Dalia R Issa, PhD
• Phone: 01007753636
• Email: dalia_rasheed[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Sticky bone and EDTA
treatment using Sticky bone after EDTA root surface biomodification
• Sticky bone
treatment using Sticky bone

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Kafrelsheikh University	Kafr El-sheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical evaluation of root coverage	the percentage of root coverage will be calculated in millimeter	6 months