NCT02385734

Brief Summary

This study hypothesized that Concentrated Growth Factors'(CGF) placement together with Coronally Advanced Flap (CAF) may enhance the healing of soft tissues. Therefore, the aim of this study was to determine the clinical effect of CGF combination with CAF compared to CAF alone in the treatment of adjacent multiple gingival recessions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

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

April 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 2, 2015

Last Update Submit

March 5, 2015

Conditions

Gingival Recession

Keywords

Multiple gingival recessionConcentrated growth factorCoronally 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 (6)

  • Percentage root coverage

    6 months

  • Keratinized gingiva width

    6 months

  • Recession depth

    6 th months

  • Gingival Thickness

    6 months

  • Probing depth

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Concentrated growth Factor Membrane

EXPERIMENTAL

Autogenous platelet and leukocyte fibrin material was obtained from blood.

Other: Concentrated Growth Factor MembraneProcedure: Coronally Advanced Flap

Coronally Advanced Flap

ACTIVE COMPARATOR

Periodontal plastic surgery procedure in the treatment of gingival recession

Procedure: Coronally Advanced Flap

Interventions

Concentrated Growth Factor MembraneOTHER

Concentrated growth factor membrane 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
Coronally Advanced FlapPROCEDURE

Periodontal plastic surgery technique

Concentrated growth Factor MembraneCoronally Advanced Flap

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
Şeyma Bozkurt Doğan, Asisstant Proffessor, Bulent Ecevit University,

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 11, 2015

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

March 11, 2015

Record last verified: 2015-03