Gingival Recession Treatment With Concentrated Growth Factor(CGF)

NCT ID: NCT03020732

Last Updated: 2019-02-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

test groups

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

control groups

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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CGF+ CAF groups SCTG+CAF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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serap karakış akcan

phd doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Berrin Ünsal

Role: STUDY_DIRECTOR

affiliated

References

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Bozkurt Dogan S, Ongoz Dede F, Balli U, Atalay EN, Durmuslar MC. Concentrated growth factor in the treatment of adjacent multiple gingival recessions: a split-mouth randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):868-875. doi: 10.1111/jcpe.12444. Epub 2015 Sep 22.

Reference Type RESULT
PMID: 26269089 (View on PubMed)

Tunaliota M, Ozdemir H, Arabaciota T, Gurbuzer B, Pikdoken L, Firatli E. Clinical evaluation of autologous platelet-rich fibrin in the treatment of multiple adjacent gingival recession defects: a 12-month study. Int J Periodontics Restorative Dent. 2015 Jan-Feb;35(1):105-14. doi: 10.11607/prd.1826.

Reference Type RESULT
PMID: 25734713 (View on PubMed)

Eren G, Atilla G. Platelet-rich fibrin in the treatment of localized gingival recessions: a split-mouth randomized clinical trial. Clin Oral Investig. 2014 Nov;18(8):1941-8. doi: 10.1007/s00784-013-1170-5. Epub 2013 Dec 22.

Reference Type RESULT
PMID: 24362634 (View on PubMed)

Jankovic S, Aleksic Z, Klokkevold P, Lekovic V, Dimitrijevic B, Kenney EB, Camargo P. Use of platelet-rich fibrin membrane following treatment of gingival recession: a randomized clinical trial. Int J Periodontics Restorative Dent. 2012 Apr;32(2):e41-50.

Reference Type RESULT
PMID: 22292152 (View on PubMed)

Jankovic S, Aleksic Z, Milinkovic I, Dimitrijevic B. The coronally advanced flap in combination with platelet-rich fibrin (PRF) and enamel matrix derivative in the treatment of gingival recession: a comparative study. Eur J Esthet Dent. 2010 Autumn;5(3):260-73.

Reference Type RESULT
PMID: 20820456 (View on PubMed)

Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.

Reference Type RESULT
PMID: 19186964 (View on PubMed)

Del Corso M, Sammartino G, Dohan Ehrenfest DM. Re: "Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study". J Periodontol. 2009 Nov;80(11):1694-7; author reply 1697-9. doi: 10.1902/jop.2009.090253.

Reference Type RESULT
PMID: 19905939 (View on PubMed)

Other Identifiers

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03/2011-16

Identifier Type: -

Identifier Source: org_study_id

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