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临床试验/NCT06719648
NCT06719648已完成不适用

Multiple Gingival Recessions Root Coverage Using Coronally Advanced Tunnel Technique Combined with a Xenogenic Dermal Matrix (Novomatrix®): a Randomized Clinical Trial

Universitat Internacional de Catalunya2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Mean root coverage

研究概览

简要总结

A randomized clinical trial comparing the modified tunnel technique with the use of acellular xenogeneic matrix and connective tissue with the use leucocyte platlet rich fibrin (L-PRF)

详细描述

Study design In the pre-surgical clinical evaluation periodontal measurements were registered at baseline and during the follow-up period: periodontal probing depth (PPD), clinical attachment level (CAL), width and length (mm) of the GR, type of GR, amount of attached gingiva (mm), depth of vestibule (mm), interdental papilla height (mm), non carious cervical lesions, visual LAC detection, gingival thickness (mm) and gingival phenotype (translucency of the periodontal probe). Intraoral photographs always showing a frontal view of the treated area were taken. Moreover, all patients received supragingival scaling and crown polishing. Patient were instructed to rinse with 0.12% Chlorhexidine, 2 times a day for 1 minute starting one week prior to the surgery. Local etiological factors in the area of treatment were controlled or modified, such as the removal and change of overflowing seals, the polishing of restorations, the adjustment of margins. In cases where the cement enamel junction is not clearly detected a reconstruction of this with resin was carried out. Finally, prior to surgery, anti-inflammatory treatment were prescribed to the patient from the day before surgery with Ibuprofen 400 mg, 1 every 8 hours for 7 days

Clinical Procedures:

Prior to surgical procedure, a sealed envelope was opened with the treatment modality (randomization table). Local infiltration anesthesia was performed on both sides (buccal and lingual/palatal) of the affected area. The surgical protocol was performed following the tunnel technique described by Allen (1994) and using microsurgical instruments for periodontal plastic surgery [KPA Allen, PPAELA, tunelisation knife black line, (Hu Fredy)]. The flap was exposed using a modified coronal tunnel technique with partia papillae elevation.

The protocol was started with intra-muscular incisions with an intrasurcular scalpel (KPA Allen) in each of the treated teeth. Elevation of the flap was performed, using the Allen elevator (PPAELA), till the mucogingival line. After reaching this limit, a partial thickness dissection started using the modified Orban knife, until full tension of the flap was eliminated. The interdental papilla's was partially elevated, without being cut from their alveolar base in order to be able to coronally advance the flap to a coronal position free from tension. The flap was extended one tooth mesial and one tooth distal of the treatment area. The separation of the flap from small muscle fibers and bundles of collagen fibers was carefully carried out until the flap can passively be positioned at least 1mm above the cement enamel junction of all the involved teeth, in order to ensure the passive reposition of the flap and the posterior suture free of tension. After assuring the adequate extension of the tunnel, preparation and decontamination of the roots was carried out using Gracey curettes, eliminating the superficial cement surface in relation to the exposed root portion in order to achieve a smooth and flat surface.

All clinical procedures were performed by the same experienced surgeon who was blind to the treatment modality. All evaluations, procedures and controls will be performed in the dental center and pavilions of the Clinic of the Universidad de los Andes and the International University of Cataluña, were two experienced peridontontis (A.C and A.P) will perform the MCAT.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • Presence of 2 or more adjacent Cairo's type I or II gingival recessions
  • Non-smokers
  • Plaque index <20% and bleeding on probing (BOP) <20%
  • Periodontal health
  • Existing endodontic therapies must be carefully evaluated. In case of inadequate treatments, endodontic retreatment will be performed (i.e., a minimum of two months before performing the surgical therapy).
  • Use of optical magnification (2.5X) and microsurgical instruments for the surgical procedure is recommended.

排除标准

  • Individuals who do not meet the inclusion criteria
  • Systemic compromise involving healing response and tissue repair, or coagulation disorders
  • Uncontrolled systemic diseases
  • Use of anticoagulant therapy or bisphosphonates
  • Active periodontal disease
  • Inadequate psychological profile
  • Patients with intentions to change residence that would prevent follow-up
  • Multiple recessions in molars

结局指标

主要结局

Mean root coverage

时间窗: Baseline, 6 and 12 months

amount of root surface covered by healthy gum tissue

次要结局

  • Complete root coverage(Baseline, 6 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres Pascual La Rocca

Periodontist

Universitat Internacional de Catalunya

研究点 (2)

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