Gingival Recession Treatment With Concentrated Growth Factor(CGF)

February 7, 2019 updated by: serap karakış akcan, Gazi University

Concentrated Growth Factor Membrane Versus Subepithelial Connective Tissue Grafts in Treatment of Multiple Gingival Recession Defects: a Split-mouth Randomized Clinical Trial

Platelet concentrates(PC) are used in the field of periodontology and implantology for the content necessary key cells and growth factors to accelerate healing and to provide regeneration. Concentrated Growth Factors(CGF) is defined as an innovative method or a new generation PC. The purpose of this clinical study was to evaluate the clinical effectiveness of Concentrated Growth Factor(CGF) membrane with coronally advanced flap(CAF) procedure's and subepithelial connective tissue graft(SCTG) with CAF in the treatment of Miller class I gingival recessions (GR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CGF is defined as an innovative method to produce platelet rich fibrin(PRF) or a new generation platelet concentrate(PC).The rotational speed of the centrifuge machine used in CGF, varies between 2400-3000 rpm. The variability of the rotation speed during centrifugation allows a fibrin matrix that larger, more intensive and includes more growth factors than PRF. Some studies have been reported that CGF have an inducing effect on periodontal ligament stem cells for osteogenic differentiation and clinically provides new bone formation for the sinus augmentation. In literature, there is only one clinical research associated with multiple gingival recession defects treatment. It showed that CGF with CAF surgery increases keratinized gingiva weight and thickness and it maybe prevents post-operative relapse for CAF.

PC has also been mentioned to be effective in to increase the width of keratinized tissue with providing root coverage and it may reduce early post-surgical complications, and accelerate wound healing in systematic review. In the treatment of isolated or multiple gingival recession, PRF and SCTG with CAF procedures have been reported to similar root coverage. PRF can be used as an alternative method for SCTG .CGF and PRF have similar composition. However higher resistance and viscosity of CGF may protect growth factors from proteolysis better than PRF. There is any comparative study for CGF and SCTG in literature in terms of clinically or patient related parameters.

Therefore, the purpose of this clinical study is to evaluate the clinical efficacy of CGF in combination with CAF in the treatment of gingival recession's defects, and to compare SCTG in combination with CAF. It is also aimed to asses and compare postoperative pain and soft tissue healing.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age≥18
  • systemically and periodontally healthy non-smoker patients
  • multiple, adjacent, bilaterally Miller class I
  • recession depth ≥2 and ≤5 mm, probing depth≤3 mm, located lateral, canine or premolars on same arch(maxilla or mandibula)
  • identifiable cemento-enamel junction
  • absence caries or restoration on buccal surface, endodontic treatment or problem
  • palatal donor tissue thickness ≥3 mm for SCTG

Exclusion Criteria:

  • patients have smoking habit or systemic diseases that might be contraindication for periodontal surgery
  • the presence of using medication affect that blood clotting mechanism and wound healing
  • previous periodontal surgeries in gingival recession areas
  • pregnancy, lactation,or oral contraceptive drug intake for female patients
  • insufficient oral hygiene (full- mouth plaque and bleeding scores ≥15% after phase I periodontal treatment)
  • unchanged traumatic tooth-brushing habit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: test groups
In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups.In test groups, a special centrifuge machine(Medifuge) and subjects venous blood were used to obtain Concentrated growth factor. A special compress was used to transform Concentrated growth factor membrane.
Procedure: test groups
Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Concentrated growth factor(CGF) membranes were placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.
Other Names:
  • CGF+ CAF groups
ACTIVE_COMPARATOR: control groups
In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups. In control groups, subepithelial connective tissue graft was taken from the palatal canine teeth-first molar teeth area with a trap door technique according to the width of the exposed root surface and the adjacent bone margins. The graft's thickness was adjusted between 1.5 and 2 mm.
Procedure: control groups
Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Subepithelial connective tissue graft was placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.
Other Names:
  • SCTG+CAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recession depth
Time Frame: change from baseline at following surgery first, third and sixth month respectively
recession depth was measured distance from cemento-enamel junction(CEJ) to the gingival margin, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.
change from baseline at following surgery first, third and sixth month respectively
root coverage
Time Frame: change from baseline at following surgery first, third and sixth month respectively
Root coverage(RC) was calculated for multiple recession defects groups with a formula.
change from baseline at following surgery first, third and sixth month respectively
keratinized tissue thickness
Time Frame: change from baseline at following surgery first, third and sixth month respectively
Keratinized tissue thickness(KTT) value was obtained from a digital caliper with the accuracy of 0.01 mm and using a 15 endodontic reamer, on mid-point localization of keratinized tissue or the alveolar mucosa, at level bottom of the gingival crevice.
change from baseline at following surgery first, third and sixth month respectively
keratinized tissue weight
Time Frame: change from baseline at following surgery first, third and sixth month respectively
keratinized tissue weight was measured distance from the free gingival margin to the mucogingival junction, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.
change from baseline at following surgery first, third and sixth month respectively
clinical attachment level
Time Frame: change from baseline at following surgery first, third and sixth month respectively
clinical attachment level was mesured distance from CEJ to the bottom of the gingival crevice
change from baseline at following surgery first, third and sixth month respectively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound healing
Time Frame: after surgery first, second and third week
Wound healing was evaluated with healing index.
after surgery first, second and third week
VAS scores for pain evaluation
Time Frame: after surgery first seven days
Visual analog scale(VAS) with 100 mm was used in patient postoperative pain level for first seven days.No pain level was indicated as 0, and unbearable pain level on the VAS was also indicates as 100.
after surgery first seven days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: change from baseline at following surgery first, third and sixth month respectively
plaque index (Silness &Löe index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.
change from baseline at following surgery first, third and sixth month respectively
Gingival index
Time Frame: change from baseline at following surgery first, third and sixth month respectively
Gingival index(Löe &Silness index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.
change from baseline at following surgery first, third and sixth month respectively
Probing pocket depth
Time Frame: change from baseline at following surgery first, third and sixth month respectively
Probing pocket depth was measured distance from the gingival margin to the bottom of the gingival crevice.
change from baseline at following surgery first, third and sixth month respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Director: Fatma Berrin Ünsal, Affiliated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

January 12, 2017

First Posted (ESTIMATE)

January 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/2011-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

there is no plan to make IPD. IPD will be formed if necessary.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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