Growth Factors in the Localized Gingival Recessions Treatment

NCT05188768 | Completed

• 1 other identifier: 36290600/38
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate the clinical efficacy of concentrated-growth-factor (CGF) in combination with coronally-advanced-flap (CAF) compared with platelet-rich-fibrin (PRF)+CAF for the treatment of localized gingival-recessions (GRs)

Conditions

Localized Gingival Recession

Keywords

localized gingival recession; Platelet rich fibrin; concentrated growth factor; coronally advanced flap

Outcome Measures

Primary Outcomes (1)

• Complete root coverage

  Change from baseline in percentage of complete root coverage at 6th months.

  6 months

Secondary Outcomes (3)

• Percentage of mean root coverage

  6 months

• Keratinized gingiva width

  6 months

• Recession depth

  6 th months

Study Arms (2)

Concentrated growth Factor Membrane

EXPERIMENTAL

Autogenous platelet and leukocyte fibrin material was obtained from blood.

Procedure: Concentrated Growth Factor Membrane; Procedure: Platelet Rich Fibrin

Platelet Rich Fibrin

ACTIVE COMPARATOR

Autogenous platelet and leukocyte fibrin material was obtained from blood.

Procedure: Concentrated Growth Factor Membrane; Procedure: Platelet Rich Fibrin

Interventions

Concentrated Growth Factor Membrane PROCEDURE

Concentrated growth factor is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix

Also known as: An agent of platelet concentrates

Concentrated growth Factor Membrane; Platelet Rich Fibrin

Platelet Rich Fibrin PROCEDURE

Platelet Rich Fibrinis produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix

Also known as: An agent of platelet concentrates

Concentrated growth Factor Membrane; Platelet Rich Fibrin

Eligibility Criteria

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

You may qualify if:

• systemically and periodontally healthy,
• non-smokers
• presence of Miller Class I and II gingival recession with ≥ 2 mm gingival recession depth , probing depth \<3 mm and gingival thickness (GT) ≥ 1 mm on both sides of the maxillary arch
• width of keratinized gingiva ≥ 2mm
• presence of identifiable cemento-enamel junction
• full-mouth plaque index (PI) \< 20 % and gingival index (GI) scores =1,
• presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area,

You may not qualify if:

• \- patients who had systemic problems that wound contraindicate for periodontal surgery, - usage of medications known to interfere with healing and to cause gingival enlargement - recession defects associated with demineralization, deep abrasion,
• previous surgery in the defects area within the past 1 year,
• pregnant or lactating females
• drug and alcohol abuse

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 25, 2021
• First Posted: January 12, 2022
• Study Start: July 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 12, 2022

Record last verified: 2021-12