Clinical trial NCT03020732: Gingival Recession Treatment With Concentrated Growth Factor(CGF)
Official title: Concentrated Growth Factor Membrane Versus Subepithelial Connective Tissue Grafts in Treatment of Multiple Gingival Recession Defects: a Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: growth factor
mucogingival surgery
gingival recession
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: recession depth
timeFrame: change from baseline at following surgery first, third and sixth month respectively
measure: root coverage
timeFrame: change from baseline at following surgery first, third and sixth month respectively
measure: keratinized tissue thickness
timeFrame: change from baseline at following surgery first, third and sixth month respectively
measure: keratinized tissue weight
timeFrame: change from baseline at following surgery first, third and sixth month respectively
measure: clinical attachment level
timeFrame: change from baseline at following surgery first, third and sixth month respectively
Secondary outcomes:
measure: wound healing
timeFrame: after surgery first, second and third week
measure: VAS scores for pain evaluation
timeFrame: after surgery first seven days
Other outcomes:
measure: Plaque index
timeFrame: change from baseline at following surgery first, third and sixth month respectively
measure: Gingival index
timeFrame: change from baseline at following surgery first, third and sixth month respectively
measure: Probing pocket depth
timeFrame: change from baseline at following surgery first, third and sixth month respectively
Locations:
Study officials:
affiliation: affiliated
name: Fatma Berrin Ünsal
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.