Dimensional Changes of the Keratinized Mucosa in Edentulous Ridges Following Accordian Technique Versus Conventional Free Gingival Grafts: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Vertical graft shrinkage %
研究概览
简要总结
Inadequacy of the attached keratinized tissue (<2 mm) affects the long-term maintenance of prostheses and implants due to poor oral hygiene, plaque accumulation, inflammation, bleeding on probing, gingival recession , attachment loss, and crestal bone loss .Consequently, keratinized tissue augmentation is considered to compensate for keratinized attached gingival width inadequacy. Lack of keratinized tissue (KT) or KT with a narrow width (≤2 mm) compromise the long-term maintenance of peri-implant tissue health . Peri-implantitis was more frequently detected at dental implants sites with reduced width of KT than at those with adequate KT width.
Free gingival graft (FGG) is regarded as an efficient method with significant clinical application . However, following harvesting larger grafts, some limitations arise in the donor site. Extensive palatal wound may cause discomfort and morbidity for the patient, the rugae area is unsuitable for graft material and the greater palatine artery will be of a great concern.
详细描述
Free gingival graft with accordion technique can expand the tissue up to 50%, and cover the recipient bed 1.5 times longer than the original graft by its alternating incisions on both edges. This avoids high rate of complications and limited amount of palatal mucosa available for grafting. It allows for the harvesting of smaller size, reducing patient morbidity and post-operative pain for augmenting wide areas. The area between the alternate incisions become epithelized with keratinized tissue by creeping of the surrounding tissues . Also, it provides having proper keratinized tissue width at large edentulous areas.
An adequate amount of keratinized tissue is required to maintain periodontal health and gingival recession . In order to preserve gingival health, a 2mm of keratinized gingiva is required. Keratinized tissue width is considered insufficient around teeth if it is below 2mm, where it will be associated with less vertical dimension, uncomfortable brushing, and unfavorable peri-implant conditions. Moreover, it was proven to be a risk factor for the severity of the peri-implant mucositis.
Wide zone of keratinized mucosa has a role in preservation of soft and hard tissue stability around dental implants, and with their long-term maintenance . Thick soft tissues have a positive impact on mucosal margin stability by reducing the mid-buccal soft tissue recession. Dental implants with lower KT width (<2 mm) were more likely to have peri-implantitis than those with adequate KT width (≥2 mm). Moreover, they are associated with higher plaque and bleeding scores .
Soft tissue augmentation is considered to increase the soft tissue volume as well as the keratinized mucosa. These plastic procedures re-establish the functional and biological stability , cleansibilty of the prosthesis and aesthetics . Soft tissue augmentation can be performed prior to implant placement, simultaneously with second stage surgery or after insertion of the final prosthesis.
The free gingival graft (FGG) and the subepithelial connective tissue graft (SCTG) are from the autogenous soft tissue grafting procedures used for the augmentation of keratinized tissue . Free gingival graft is indicated to increase the attached gingiva, elimination of the frenum and muscular attachments, root coverage, and vestibular extension.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with apico-coronal keratinized tissue width less than 2 millimeters
- •Edentulous area with at least 2 missing teeth
- •No systemic disease or active periodontitis
- •Non smoker
- •Age ≥ 20 years old .
- •Plaque index and bleeding index < 25%.
- •Teeth loss with medium to thick gingival biotype (Periodontal probe not visible when inserted into the buccal gingival margin).
- •Fully autonomous behavior and expression ability with good compliance.
排除标准
- •Patients with any systemic disease
- •Patients with symptoms such as inflammation, bleeding on probing, or pus discharge.
- •Poor oral hygiene
- •Adjacent teeth with acute and chronic tooth disease at the implant site
- •Smokers ≥ 10 cigarettes/day.
研究组 & 干预措施
Interventional group ( Accordian Group )
steps from 1-7 as Active comparator group + 7 -Free gingival graft will be harvested from the palatal area, as previously mentioned, with a length of 40% of the mesiodistal length of the recipient area. Intermittent incisions to cover the whole length of the recipient area. 8- The graft will be located at the recipient area, and sutured with interrupted sutures.
干预措施: Expanded mesh free gingival graft ( Accordian technique ) (Procedure)
Conventional free gingival graft
1- Infiltration anesthesia at the recipient area. 2- A horizontal incision, 0.5mm above the mucogingival junction extending along the area of the missing teeth. 3-Two vertical incisions diverging slightly in a corono-apical direction and extending into the alveolar mucosa. 4-The trapezoidal area will be dissected split thickness to expose the periosteum. 5-Infiltration anesthesia at the palatal area. 6-The free gingival graft will be harvested from the palate consisting of epithelial connective tissue of thickness more than 1mm.7- The palatal graft thickness will be determined by the coronal horizontal incision and the releasing incisions. The blade will be inserted perpendicular to the underlying deep tissue layers to a depth equal to the required graft thickness. 8- The graft will be harvested by inclining the blade horizontally, keeping it parallel to the external mucosal plane.9- The graft will be located at the recipient area, and sutured with interrupted sutures.
干预措施: conventional free gingival graft (Procedure)
结局指标
主要结局
Vertical graft shrinkage %
时间窗: Baseline 3 months
Vertical graft shrinkage will be measured using UNC 15 Periodontal probe from reference point that will be taken (mid of the ridge) from where the graft will be sutured 3 months post-surgery
次要结局
- Apico coronal keratinized tissue width(Baseline 3 months)
- Vestibular depth(Baseline 3 months)
- Keratinized tissue thickness(Baseline 3 months)
- Post surgical pain assessment(Day 1 Day 3 Day 14)
- Patient satisfaction(3 months)
研究者
Mohamed Essam Mohamed Khalifa
principal investigator
Cairo University