Comparative evaluation of Sub-epithelial connective tissue graft and Xenogenic collagen membrane in the treatment of gingival recession: A Randomised controlled clinical trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Coverage of gingival recession in terms of both recession depth & width
研究概览
简要总结
According to Glossaryof Periodontal terms (2001), gingival recession is defined as the apicaldisplacement of gingival margin in relation to cement enamel junction. One ofthe common clinical findings in periodontal disease is gingival recession. Theattachment loss is because of the collapse of gingival tissue and destructionof periodontal connective tissue.
Various factors likeplaque induced inflammation, trauma, high frenum attachment, traumaticbrushing, lack of alveolar bone due to lip and tongue piercing, dehiscence,orthodontic movement, ageing, abnormal tooth position in the dental arch,iatrogenic factors, biologic width violation, smoking and tobacco chewinghabits have been suggested as etiological factors for gingival recession.Gingival recession carries with itself not only aesthetic discrepancies butalso leads to exposure of root surface. The exposure of root surface isassociated with root hypersensitivity, difficulties in achieving optimal plaquecontrol and development of root caries. Therefore, procedures involved in thetreatment of gingival recession improve aesthetics by restoring natural tissueblending. These procedures also increase the thickness of soft tissues thatfacilitate plaque control and prevent periodontal breakdown and development ofroot caries.
As one of the greatest aestheticconcerns associated with the periodontal tissues is gingival recession,research is going on to find treatment modalities to address all the biologicaland functional problems. This has led to the development of several new andmodified surgical techniques. There are various surgical techniques and theirmodifications for the treatment of gingival recession. Surgical procedures usedin the treatment of recession defects may be categorised as coronally advancedflap, pedicle soft tissue grafting procedures (lateral sliding flap, doublepapilla flap), coronally repositioned flap and free soft tissue graftingprocedures such as epithelialized grafts or subepithelial connective tissuegrafts.
SCTG helps in improvedlong-term stability of complete root coverage (CRC) and it is accepted as thegold standard in the treatment of gingival recessions. However, the requirementof a second surgical site, limited amount of graft, rather low patienttolerance and high complication rates in donor area are the major disadvantagesof SCTG. To reduce these disadvantages, barrier membrane, platelet-rich plasma,platelet-rich fibrin, enamel matrix derivatives and graft substitute materialshave been used as an alternative to SCTG.
Periodontalconnective tissue predominantly consists of type 1 collagen fibres. Thus,researchers developed many different kinds of collagen membranes for using asgrafting material using type 1 collagen as the major component. The additionalbenefits of collagen material is hemostasis, chemotaxis for periodontalfibroblasts, gingival fibroblasts, weak immunogenicity, easy manipulation andability to augment tissue thickness. Hence, collagen appears as an ideal choicefor use in guided tissue regeneration procedures and soft tissue grafting.
Recently, a newxenogeneic collagen membrane (XCM) has been used in periodontal regenerativeprocedures. It is highly biocompatible and contains purified intact collagen. Ithas high mechanical strength. Also, it is soft and very drapable, yetrepositionable for precise adjustment and placement. It has an additionaladvantage that it does not stick to instruments. Hence, XCM seems to be apromising soft tissue graft substitute. It is not only less invasive and time savingbut also provides unlimited off-the-shelf supply of graft material and has beencleared by U.S. Food and Drug Administration (FDA). Very few studies have beendone on the use of XCM for root coverage procedures. Hence, the presentresearch work aims to evaluate and compare SCTG and XCM in the treatment ofgingival recession using the modern alteration of coronally advanced tunneltechnique.
In our study, we aim toevaluate and compare the clinical efficacy of XCM to SCTG in the treatment ofMiller’s class I / class II gingival recession.
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 and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy subjects with class I (Marginal tissue recession, which does not extend to the mucogingival junction (MGJ)) /II (Marginal tissue recession extending to or beyond mucogingival junction (MGJ) 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.
- •Subjects who were available for follow up.
排除标准
- •Persistence of uncorrected gingival trauma from tooth brushing.
- •Presence of severe tooth malposition, rotation or clinically significant supraeruption.
- •Cervical or root caries, cervical abrasion, prosthetic crown and restorations involving cemento-enamel junction.
- •Pregnant and lactating mothers.
- •Hypersensitivity or allergy to the collagen based medical products.
结局指标
主要结局
Coverage of gingival recession in terms of both recession depth & width
时间窗: Baseline, & at 3 & 6 months
次要结局
- Gain in keratinised tissue width, Clinical attachment level, Probing Depth(and attached gingiva thickness)