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

NCT04980066 | Recruiting

• 1 other identifier: KD/10/21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

i-PRF; EDTA

Outcome Measures

Primary Outcomes (1)

• clinical evaluation of root coverage

  the percentage of root coverage will be calculated in millimeter

  6 months

Study Arms (2)

sticky bone and EDTA

EXPERIMENTAL

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

Procedure: Sticky bone and EDTA

Sticky bone

ACTIVE COMPARATOR

treatment of gingival recession using sticky bone

Procedure: Sticky bone

Interventions

Sticky bone and EDTA PROCEDURE

treatment using Sticky bone after EDTA root surface biomodification

sticky bone and EDTA

Sticky bone PROCEDURE

treatment using Sticky bone

Sticky bone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Interventions

Edetic Acid

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Dalia R Issa, PhD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia R Issa, PhD

CONTACT

01007753636; dalia_rasheed@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal invistigator

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 28, 2021
• Study Start: August 3, 2021
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

EG (1)