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

NCT ID: NCT04980066

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-03

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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sticky bone and EDTA

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

Group Type EXPERIMENTAL

Sticky bone and EDTA

Intervention Type PROCEDURE

treatment using Sticky bone after EDTA root surface biomodification

Sticky bone

treatment of gingival recession using sticky bone

Group Type ACTIVE_COMPARATOR

Sticky bone

Intervention Type PROCEDURE

treatment using Sticky bone

Interventions

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Sticky bone and EDTA

treatment using Sticky bone after EDTA root surface biomodification

Intervention Type PROCEDURE

Sticky bone

treatment using Sticky bone

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Rasheed Issa

principal invistigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia R Issa, PhD

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

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Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dalia R Issa, PhD

Role: CONTACT

01007753636 ext. 002

Facility Contacts

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Dalia R Issa, PhD

Role: primary

01007753636 ext. 002

Other Identifiers

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KD/10/21

Identifier Type: -

Identifier Source: org_study_id

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