跳至主要内容
临床试验/CTRI/2022/11/047783
CTRI/2022/11/047783尚未招募不适用

clinical outcomes of modified coronally advanced tunnel technique using sub-epithelial connective tissue graft , xenogenic collagen matrix (XCM) and XCM with injectable platelet rich fibrin in the treatment of RT1 gingival recession : A three arm randomized controlled clinical trial

other1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
other
入组人数
30
试验地点
1
主要终点
modified Coronally advanced tunnel flap with xenogeneic collagen matrix (XCM) and i-prfto be similarly effective as coronally advanced flap with sub-epithelial connective tissue graft (SCTG) in root coverage procedures in terms of recession depth (RD) and percentage root coverage (RC) at baseline, 1 week, 6 months

研究概览

简要总结

There are various surgical techniques and their modifications for the treatment of gingival recession. These include pedicle grafts (lateral sliding or double papillae) with or without connective tissue grafts, epithelised autogenous grafts (free gingival), sub-epithelial connective tissue grafts (SCTG), coronally advanced flaps (CAF) alone, CAF preceded by a free gingival graft, and CAF with a simultaneous SCTG.

SCTG helps in improved long-term stability of complete root coverage (CRC) and it is accepted as the gold standard in the treatment of gingival recessions. However, the requirement of a second surgical site, limited amount of graft, rather low patient tolerance and high complication rates in donor area are the major disadvantages of SCTG.

To reduce these disadvantages, barrier membrane, platelet-rich plasma, platelet-rich fibrin, enamel matrix derivatives and graft substitute materials have been used as an alternative to SCTG. But studies have shown that only SCTG in conjunction with CAF was able to enhance the ability to achieve complete root coverage and to improve recession reduction.

Human acellular dermal matrix (ADM) was introduced as SCTG substitute with various surgical techniques aiming root coverage but no additional benefit over CAF+SCTG was found. Additionally, there is a possible risk for disease transmission as it is derived from cadavers which limited the use of this material.

Recently, a new bi-layer xenogeneic collagen matrix (XCM) has been used in periodontal regenerative procedures. XCM is composed of a cell occlusive layer with compact collagen fibre and a spongious layer with porous collagen structure. This porous layer provides stabilization of blood clot and necessary space that helps in cell migration and might increase the formation of keratinized tissue. Hence, XCM seems to be a promising soft tissue graft substitute when used with CAF. It is not only less invasive and time consuming but also provides unlimited off-the-shelf supply of graft material and has been cleared by U S Food and Drug Administration (FDA).

Injectable platelet-rich fibrin (i-PRF) has been produced by changing the type of the tube, centrifugation time and speed; specifically, the blood is centrifuged in plastic tubes at 700 rpm for 3 min (Miron & Choukroun, 2017). I-PRF prepared according to low-speed centrifugation concept can provide a significant advantage for the regeneration process, as it is rich in platelets, leucocytes and growth factors (Choukroun & Ghanaati,2018).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Patient with age of ≥18 years.
  • Presence of bilateral Miller’s class I (Marginal tissue recession, which does not extend to the mucogingival junction (MGJ)) / class II (Marginal tissue recession extending to or beyond mucogingival junction(MGJ)) gingival recession of same depth on buccal aspect of anterior teeth and premolars with no radiographic sign of bone loss and requiring surgical intervention for root coverage, Probing pocket depth <3mm, No prior history of any surgical procedures on the site to be treated, Presence of detectable CEJ, Not using tobacco in any form, Systemically healthy subjects with no contraindication to periodontal surgery, Able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS<10% and FMBS<10%) Patient willing to undergo surgical procedure and giving written informed consent.

排除标准

  • 未提供

结局指标

主要结局

modified Coronally advanced tunnel flap with xenogeneic collagen matrix (XCM) and i-prfto be similarly effective as coronally advanced flap with sub-epithelial connective tissue graft (SCTG) in root coverage procedures in terms of recession depth (RD) and percentage root coverage (RC) at baseline, 1 week, 6 months

时间窗: modified Coronally advanced tunnel flap with xenogeneic collagen matrix (XCM) and i-prfto be similarly effective as coronally advanced flap with sub-epithelial connective tissue graft (SCTG) in root coverage procedures in terms of recession depth (RD) and percentage root coverage (RC) at baseline, 1 week, 6 months.

次要结局

  • relative attachment level, keratinized tissue height, keratinized tissue thickness , recession width and root coverage esthetic score in patients treated with XCM and iprf when compared to patients treated with SCTG and XCM only(at 6 months)

研究者

发起方
other
申办方类型
Other [clinician]

研究点 (1)

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