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Gingival Recession Treatment With Concentrated Growth Factor(CGF)

G

Gazi University

Status

Completed

Conditions

Gingival Recession

Treatments

Procedure: test groups
Procedure: control groups

Study type

Interventional

Funder types

Other

Identifiers

NCT03020732
03/2011-16

Details and patient eligibility

About

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).

Full 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.

Enrollment

19 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 2 patient groups

test groups
Experimental group
Description:
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.
Treatment:
Procedure: test groups
control groups
Active Comparator group
Description:
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.
Treatment:
Procedure: control groups

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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