Gingival Recession Treatment With Concentrated Growth Factor(CGF)

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: control groups; Procedure: test groups

• Registration Number: NCT03020732
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2016-12-30
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
control groups	control groups	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.
test groups	test groups	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.

Primary Outcome Measures

Name	Time	Method
root coverage	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	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	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.
recession depth	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.
clinical attachment level	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 Outcome Measures

Name	Time	Method
VAS scores for pain evaluation	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.
wound healing	after surgery first, second and third week	Wound healing was evaluated with healing index.