Clinical Trial: Gingival Recession Treatment With Concentrated Growth Factor(CGF)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 multiple Miller class I gingival recessions (GR).

Detailed Summary:

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 multiple 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.

Sponsor: Gazi University

Current Primary Outcome:

• 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.
• 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.
• 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.
• 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.
• 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

Original Primary Outcome:

• 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 milimeters.
• 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.
• 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.
• 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 milimeters.
• 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

Current Secondary Outcome:

• wound healing [ Time Frame: after surgery first, second and third week ]
  Wound healing was evaluated with healing index.
• 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.

Original Secondary Outcome: Same as current

Information By: Gazi University

Dates:
Date Received: December 30, 2016
Date Started: February 2013
Date Completion:
Last Updated: January 13, 2017
Last Verified: January 2017