Evaluation of Dose-dependent Platelet-rich Fibrin Membrane Effect on Treatment of Gingival Recessions: A Randomized, Controlled, Parallel-designed Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Change from baseline clinical measurement of gingival depth and gingival recession by periodontal Williams Type Probe as millimeter at postoperative 6 month
研究概览
简要总结
Miller Class I Gingival Recessions (GR) have been treated by using Coronally Advanced Flap (CAF) with Platelet Rich Fibrin membrane (PRF membrane) or Connective Tissue Graft (CTG). The aim of this study was to evaluate the effect of different multiple layers of PRF membranes for the treatment of GR and compare the results with CTG procedure.
详细描述
The Coronally Advanced Flap (CAF) has been used in combination with various techniques to increase the coverage and obtain the CRC. CAF+connective tissue graft and CAF+platelet concentrated graft are some of these procedures.
Because of a high success rate in the treatment of GR, CAF combined Connective Tissue Graft (CTG) procedure (bilaminar technique) is considered the gold standard for Miller Class I and II recession defects. According to recent studies CAF + CTG is described as a successful technique with a high CRC value and the percent root coverage achieved with this technique ranges from 79.9% to 89.6%. The advantage of this technique is the enhancement of keratinized tissue width which can be explained by the determination of surface epithelium characteristics of CTG. Moreover, there are disadvantages such as patient's discomfort because of postoperative pain or bleeding and second surgical area.
Therefore, the aim of this study was to evaluate the different doses of PRF membranes for the treatment of Miller Class I gingival recessions and compare with CTG procedure that is considered the gold standard.
MATERIALS AND METHODS In this study, sixty-three Miller Class I gingival recessions in twenty two subjects (10 males and 12 females, aged 21 to 52 years) were treated.
Study design This study was a randomized, controlled clinical trial, with a parallel design comparing different amount layers of PRF membranes and CTG for the treatment of Miller Class I gingival recessions. In the test group-1, 21 randomly selected GR were treated with 2 layers PRF membranes(2PRF)+CAF; in the test group-2, 21 randomly selected GR were treated with 4 layers PRF membranes (4PRF) +CAF and in the control group 21 randomly selected GR were treated with CTG+CAF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontally and systemically healthy patient, ≥ 18 years.
- •Miller Class I gingival recession at the buccal aspect of lower and upper incisors, canines or premolars.
- •The presence of ≥ 2 mm keratinized tissue apical to the recession.
- •The presence of identifiable cemento enamel junction (CEJ).
- •≤ 2 mm probing depth (PD)
排除标准
- •Periodontal surgery in the past six months.
- •Caries, deep abrasion, restoration or pulpal pathology on the involved tooth.
研究组 & 干预措施
2PRF+CAF
Two tubes of blood samples were centrifuged by PC-02 Centrifuged device. This centrifuged device is used with 2700 rpm and for 12 minutes( PC-02 Centrifuge, Process,France). PRF were prepared for patients in 2 layer platelet rich fibrin membrane with coronally advanced flap group (2PRF+CAF).
Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In 2PRF+CAF group: two layers of stacked PRF membranes were positioned over the recession area at the level of CEJ and flpa is positioned coronally.
干预措施: PC-02 Centrifuge device,2PRF+CAF (Device)
2PRF+CAF
Two tubes of blood samples were centrifuged by PC-02 Centrifuged device. This centrifuged device is used with 2700 rpm and for 12 minutes( PC-02 Centrifuge, Process,France). PRF were prepared for patients in 2 layer platelet rich fibrin membrane with coronally advanced flap group (2PRF+CAF).
Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In 2PRF+CAF group: two layers of stacked PRF membranes were positioned over the recession area at the level of CEJ and flpa is positioned coronally.
干预措施: PC-02 Centrifuge device, 4 PRF+CAF (Device)
2PRF+CAF
Two tubes of blood samples were centrifuged by PC-02 Centrifuged device. This centrifuged device is used with 2700 rpm and for 12 minutes( PC-02 Centrifuge, Process,France). PRF were prepared for patients in 2 layer platelet rich fibrin membrane with coronally advanced flap group (2PRF+CAF).
Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In 2PRF+CAF group: two layers of stacked PRF membranes were positioned over the recession area at the level of CEJ and flpa is positioned coronally.
干预措施: CTG+CAF (Procedure)
4PRF+CAF
Four tubes of blood samples were centrifuged by PC-02 Centrifuged device,four layers of PRF membranes were prepared for patients in 4 layer platelet rich fibrin membrane with coronally advanced flap.(4PRF+CAF). This centrifuged device is used with 2700 rpm and for 12 minutes( PC-02 Centrifuge, Process,France) Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In 4PRF+CAF group: four layers of stacked PRF membranes were positioned over the recession area at the level of CEJ and flap is coronally positioned.
干预措施: PC-02 Centrifuge device,2PRF+CAF (Device)
4PRF+CAF
Four tubes of blood samples were centrifuged by PC-02 Centrifuged device,four layers of PRF membranes were prepared for patients in 4 layer platelet rich fibrin membrane with coronally advanced flap.(4PRF+CAF). This centrifuged device is used with 2700 rpm and for 12 minutes( PC-02 Centrifuge, Process,France) Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In 4PRF+CAF group: four layers of stacked PRF membranes were positioned over the recession area at the level of CEJ and flap is coronally positioned.
干预措施: PC-02 Centrifuge device, 4 PRF+CAF (Device)
4PRF+CAF
Four tubes of blood samples were centrifuged by PC-02 Centrifuged device,four layers of PRF membranes were prepared for patients in 4 layer platelet rich fibrin membrane with coronally advanced flap.(4PRF+CAF). This centrifuged device is used with 2700 rpm and for 12 minutes( PC-02 Centrifuge, Process,France) Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In 4PRF+CAF group: four layers of stacked PRF membranes were positioned over the recession area at the level of CEJ and flap is coronally positioned.
干预措施: CTG+CAF (Procedure)
CTG+CAF
The surgical technique in coronally advanced flap with subepithelial connective tissue graft (CTG+CAF) group was "envelope technique" as described by Raetzke. The papillae were dis epithelialized. The root was planned and hard accumulations were removed but no chemical root treatment was performed. The connective tissue graft was harvested from the palate using "trap-door technique" described by Edel. Epithelial layer was elevated with a horizontal and two vertical incisions. The connective tissue graft was harvested as 1 mm by using a standard caliper, then epithelial layer was sutured by resorbable suture. The connective tissue graft was sutured to the recipient bed by resorbable suture at the level of CEJ.
干预措施: PC-02 Centrifuge device,2PRF+CAF (Device)
CTG+CAF
The surgical technique in coronally advanced flap with subepithelial connective tissue graft (CTG+CAF) group was "envelope technique" as described by Raetzke. The papillae were dis epithelialized. The root was planned and hard accumulations were removed but no chemical root treatment was performed. The connective tissue graft was harvested from the palate using "trap-door technique" described by Edel. Epithelial layer was elevated with a horizontal and two vertical incisions. The connective tissue graft was harvested as 1 mm by using a standard caliper, then epithelial layer was sutured by resorbable suture. The connective tissue graft was sutured to the recipient bed by resorbable suture at the level of CEJ.
干预措施: PC-02 Centrifuge device, 4 PRF+CAF (Device)
CTG+CAF
The surgical technique in coronally advanced flap with subepithelial connective tissue graft (CTG+CAF) group was "envelope technique" as described by Raetzke. The papillae were dis epithelialized. The root was planned and hard accumulations were removed but no chemical root treatment was performed. The connective tissue graft was harvested from the palate using "trap-door technique" described by Edel. Epithelial layer was elevated with a horizontal and two vertical incisions. The connective tissue graft was harvested as 1 mm by using a standard caliper, then epithelial layer was sutured by resorbable suture. The connective tissue graft was sutured to the recipient bed by resorbable suture at the level of CEJ.
干预措施: CTG+CAF (Procedure)
结局指标
主要结局
Change from baseline clinical measurement of gingival depth and gingival recession by periodontal Williams Type Probe as millimeter at postoperative 6 month
时间窗: before surgery and following surgery sixth month
All clinical measurement were recorded by same periodontal probe(Williams Probe)as height in meters. All measurement were calculated as mean ± standard deviation for per tooth. Clinical measurement following as: 1) Recession Depth: the distance from the CEJ to the most apical point of free gingival margin. 2) Recession Width: horizontal distance of recession in the mesio-distal direction at CEJ 3) Keratinized Tissue Height (KTH): the distance from the mucogingival junction to free gingival margin. 4)Probing Depth 5) Clinical Attachment Level
Change from baseline measurement of keratinized tissue thickness on defects region by spreader and digital calliper at 6 months
时间窗: before surgery and following surgery sixth month
2) Keratinized Tissue Thickness (KTT): Keratinized tissue thickness was measured under local anesthesia from a mid-point location between the gingival margin and mucogingival junction with a spreader and its stopper silicon
Change from baseline measurement root coverage at 6 months in millimeters by periodontal probe and change from baseline measurement of root coverage percentage using calculate formula at 6 months
时间窗: before surgery and following surgery sixth month
Root Coverage: (RC) was calculated in millimeters and percentages according to the following formulas: \[(pre operative RD - post operative RD) / pre operative RD\]×100.
次要结局
- Number of participant with treatment related postoperative pain using Visual Analogue Scale on application of PRF and CAF+CTG(first and seventh day)