Gingival Recession Treatment With Concentrated Growth Factor(CGF)

NCT03020732 | Completed

• 1 other identifier: 03/2011-16
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Gingival Recession

Keywords

growth factor; mucogingival surgery; gingival recession

Outcome Measures

Primary Outcomes (5)

• recession depth

  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

  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

  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

  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

  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 Outcomes (2)

• wound healing

  after surgery first, second and third week

• VAS scores for pain evaluation

  after surgery first seven days

Other Outcomes (3)

• Plaque index

  change from baseline at following surgery first, third and sixth month respectively

• Gingival index

  change from baseline at following surgery first, third and sixth month respectively

• Probing pocket depth

  change from baseline at following surgery first, third and sixth month respectively

Study Arms (2)

test groups

EXPERIMENTAL

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

control groups

ACTIVE COMPARATOR

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

Interventions

test groups 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.

Also known as: CGF+ CAF groups

test groups

control groups 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.

Also known as: SCTG+CAF

control groups

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Related Publications (7)

• 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.

  PMID: 26269089 RESULT

• 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.

  PMID: 25734713 RESULT

• 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.

  PMID: 24362634 RESULT

• 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.

  PMID: 22292152 RESULT

• 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.

  PMID: 20820456 RESULT

• 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.

  PMID: 19186964 RESULT

• 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.

  PMID: 19905939 RESULT

MeSH Terms

Conditions

Gingival Recession

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Fatma Berrin Ünsal

  affiliated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phd doctor

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 13, 2017
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 11, 2019

Record last verified: 2019-02