NCT04261634

Brief Summary

This study hypothesized that CGFs' placement together with CAF may enhance the healing of soft tissues better than use of PRF together with CAF. Therefore, the aim of this study was to determine the clinical effects of CGF in combination with CAF compared to the clinical effect of PRF in combination with CAF in the treatment of adjacent multiple GRs.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

February 6, 2020

Last Update Submit

February 6, 2020

Conditions

Keywords

multiple gingival recessionplatelet rich fibrinconcentrate growth factor

Outcome Measures

Primary Outcomes (1)

  • Complete root coverage

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

    6 months

Secondary Outcomes (4)

  • Percentage root coverage

    6 months

  • Keratinized gingiva width

    6 months

  • Recession depth

    6 th months

  • Probing 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 MembraneProcedure: Platelet Rich Fibrin

Platelet Rich Fibrin

ACTIVE COMPARATOR

Autogenous platelet and leukocyte fibrin material was obtained from blood.

Procedure: Concentrated Growth Factor MembraneProcedure: Platelet Rich Fibrin

Interventions

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 MembranePlatelet Rich Fibrin

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 MembranePlatelet Rich Fibrin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • systemically and periodontally healthy,
  • non-smokers
  • presence of ≥ 2 buccal adjacent 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

May 1, 2017

Last Updated

February 10, 2020

Record last verified: 2020-02