Surgical Outcomes of Decortication With or Without Calcium Phosphosilicate Putty Following Regenerative Therapy of Non-Contained Intrabony Periodontal Defects: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Bone fill,
研究概览
简要总结
To overcome the disadvantage of complex morphology and availability of less favorable support to retention of graft and clot stabilization in 1-, 1-2-wall periodontal defects, it was hypothesized that placement of CPS putty having the property of being easily moldable and shaped along with decortication would provide better healing outcome as compared to decortication alone in 1-, 1-2-wall periodontal defects.
Therefore with this rationale, the present study is carried out to evaluate the treatment outcomes of decortication with and without use of CPS putty in 1- wall, 1-2-wall periodontal defects.
详细描述
The definite goal of periodontal regenerative therapy is to restore the tooth supporting tissues, lost as a result of inflammatory periodontal diseases and infections. Numerous treatment modalities have been described and tested, including use of non resorbable and resorbable membranes (GTR) ; autogenous bone grafts, bone allografts, xenografts and synthetic materials, and bioactive molecules (EMD) and growth factors. Furthermore researches on cell therapy and gene therapy utilization to boost the reparative potential of the wound tissues are also being carried out. Each of the treatment modalities have their own limitations and advantages.
Autogenous bone grafts having good osteogenic and osteoconductive capacity than other grafts are considered to be the best but need for a second surgery, postoperative complaints and insufficient amount of bone graft obtained restrict their use. Allografts and xenografts use is also limited because of their controversial osteoinduction capability, ethical problems, infections and immunological rejection risk. As a result of the varying disadvantages of the auto-, allo- and xenografts, synthetic bone graft use is slowly increasing. These have advantages of good osteoconductivity, no ethical or problems of infection and production of these grafts can be unlimited. The disadvantages lies in their lack of osteogenic and osteoinductive properties.
One such synthetic material is bioactive glass developed by Hench and West In late 1960s. It is available in particulate as well as putty form. Calciumphosphosilicate (CPS) putty (NOVABONE Dental Putty, Novabone products Pvt. Ltd., INDIA) is a new next generation bone graft material built with bioactive glass platform with additives like polyethylene glycol and glycerin to improve handling and efficiency. It is available as a premixed pliable cohesive material. It's not only an osteoconductive material but also imparts osteostimulative effect. CPS putty stimulates osteoblast recruitment, proliferation and differentiation at the defect site and increases rate of bone formation throughout the defect, simultaneously increasing the resorption rate of the graft material. Bembi et al. reported that mean percentage change in amount of radiographic bone fill was more in the treatment of intrabony defects with novabone putty as compared to calcified algae- derived porous hydroxyapatite bone graft. In another study Biswas et al. concluded that use of bioactive glass osteostimulative biomaterial yields superior clinical results, including increased pocket depth reduction of class II furcation defects as compared to an autologous platelet concentrate.
Controversial reports have been reported on outcomes of healing in reference to number of bony walls remaining. Therefore type of periodontal defect might influence the effect of grafts and membrane on periodontal regeneration. Contained intrabony periodontal defects (3- walled) offer a higher predictability in the regenerative procedures as compared to non-contained infrabony periodontal defects (1-,2- wall defects) as the later morphology is complex due to limited buccal and lingual periodontal tissue component. The one wall periodontal defect offers less favorable support to the flap and clot stabilization,. Studies have shown considerable variations of results as these defects have larger width (as compared to 3-wall defects); osteoconductivity is difficult to obtain; blood supply to the gingival flap at the graft site is insufficient and gingival recession tends to occur. Selvig et al. reported that the percentage of 3-wall intrabony defect was less than 30% and a combination of 1-wall and 2- wall defects was mainly observed. The prevalence of later is more hence development of predictable periodontal regeneration holds a greater importance in these cases.
MATERIALS AND METHODS
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with chronic periodontitis
- •Presence of non- contained osseous defect
- •Age 28 to 60 years (both males and females)
- •Completed etiological periodontal therapy (oral hygiene instructions and scaling and root planing under local anaesthesia.
- •At re-evaluation full mouth plaque score67 < 1, full mouth bleeding score FMBS <20%
- •Non-smokers (Current and past smokers)
- •Presence of ≥ 2mm of keratinized tissue to allow flap management
- •Tooth defect criteria:
- •Probing pocket depth ≥ 5mm
- •Clinical attachment loss ≥ 5mm
- •Associated with a 1-wall, 2-wall or a combined 1-2 wall osseous defect ≥ 3mm deep located in the interproximal area of single- and multirooted teeth (assessed by transgingival probing and radiograph, further to be confirmed after flap elevation)
- •Tooth mobility ≤ 1
- •Concerned tooth and adjoining teeth to be vital and without symptoms or signs of endodontic involvement
- •Tooth and adjoining teeth free of caries or inadequate restorations/ unrestorable tooth.
- •Absence of non-working interferences.
- •Interproximal intrabony defects not extending into the furcation area of molar teeth.
排除标准
- •Medical conditions interfering with periodontal health or wound healing
- •Systemic illness known to affect the periodontium or outcome of periodontal therapy.
- •Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
- •Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
- •Pregnant or lactating women.
- •Fractured/perforated roots.
- •Developing permanent tooth.
- •History of recent periodontal treatment within 6 months prior to study.
- •3-wall intrabony defects
研究组 & 干预措施
Test Group OFD+IMP+CPS
OFD+IMP+CPS; open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty (CPS)
干预措施: OFD+IMP+CPS (Procedure)
Control group (OFD+IMP)
OFD+IMP;open flap debridement (OFD) and intramarrow penetration (IMP)
干预措施: OFD+IMP (Procedure)
结局指标
主要结局
Bone fill,
时间窗: 12 months
bone growth fill in mm
CAL
时间窗: 12 months
clinical attachment level gain in mm
次要结局
未报告次要终点
