Concentrated Growth Factor Membrane Versus Subepithelial Connective Tissue Grafts in Treatment of Multiple Gingival Recession Defects: a Split-mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- root coverage
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: test groups (Procedure)
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.
干预措施: control groups (Procedure)
结局指标
主要结局
root coverage
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- VAS scores for pain evaluation(after surgery first seven days)
- wound healing(after surgery first, second and third week)
研究者
serap karakış akcan
phd doctor
Gazi University