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Completed

NCT Number: NCT03020732

Gingival Recession Treatment With Concentrated Growth Factor(CGF)

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CGF+ CAF 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.

Other names: SCTG+CAF

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Secondary outcomes

  1. wound healing

    Time frame: after surgery first, second and third week

    Wound healing was evaluated with healing index.

  2. 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.

Other outcomes

  1. Plaque index

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

    plaque index (Silness &Löe index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.

  2. Gingival index

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

    Gingival index(Löe &Silness index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.

  3. Probing pocket depth

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

    Probing pocket depth was measured distance from the gingival margin to the bottom of the gingival crevice.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 13, 2017
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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