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临床试验/CTRI/2023/11/059413
CTRI/2023/11/059413尚未招募4 期

Comparative evaluation of Vestibular Incision Subperiosteal Tunnel access(VISTA) technique alone and in combination with platelet rich fibrin(PRF) for the treatment of multiple gingival recessions

未提供1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年11月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
24
试验地点
1
主要终点
Reduction of gingival marginal recession depth

研究概览

简要总结

Aim of the study is to comparative evaluation of vestibular incision subperiosteal tunnel access(VISTA) technique alone and in combination with platelet rich fibrin(PRF) for the treatment of multiple gingival recessions. All the participants will be explained the need and design of the study. Informed and written consent will obtained from the patients. Thorough clinical case history will be recorded. Each patient will undergo ultrasonic scaling (ems) by a single operator. All clinical parameters (PI,BOP,RD,RW,CAL,KTG,RES,PD,PERCENTAGE ROOT COVERAGE) will be measured using UNC 15 periodontal probe(Hufriedy) at baseline, 3 months and 6 months and VAS will be recorded at 1st day, 10th day, 3 months and 6 months post surgically. It is a single blind study in which the patient will be randomly assigned to either VISTA (control group) or VISTA with PRF (test group) using manual lottery method. After allotment of the groups following surgical procedure will be performed.

For control group (VISTA technique)-

The procedure will be carried out under local anesthesia (lignocaine HCL with 2% epinephrine 1: 200,000). Disinfection of the surgical site will be done with 2% betadine. The vista approach will      begin with the vestibular access incision below mucogingival junction and the location of the access incision will be mesially or distally depending on the sites being treated. The incision is made      through periosteum to elevate a sub periosteal tunnel, exposing the facial osseous plate as well as root dehiscence. This tunnel will be extended at least one or two teeth beyond the teeth                requiring root coverage to mobilize gingival margin and facilitate coronal repositioning. A microsurgical periosteal elevator (vista 4) is used to extend the subperiosteal tunnel. The vista elevator is    introduced through the vestibular access incision and inserted between the periosteum and bone to elevate the periosteum, creating the subperiosteal tunnel. It is important to extend the tunnel      elevation sufficiently beyond the mucogingival margin as well as through the gingival sulcus of the teeth being augmented to allow for low-tension coronal repositioning of the gingiva. Additionally,    the subperiosteal tunnel is extended interproximally under each papilla as far as the embrasure space permitted, without making any surface incisions through the papillae. This subperiosteal          tunnel is repositioned coronally and adapted passively to cej covering the recession defects. Coronally anchored sutures are placed engaging the 2–3 mm apical gingival margin of individual            tooth  using 4-0 silk suture. The suture is secured at the midcoronal point of the facial aspect of each tooth with the help of composite resin button to prevent apical relapse of the gingival margin.    Once coronal stabilization and proper adaptation of the marginal gingiva is achieved then the vertical incision is sutured for the primary closure. Complete surgical site is covered with coe-pack.

For test group (VISTA with PRF technique)-

A) preparation of PRF - around 5 ml of whole venous blood is collected in each of the two sterile vacutainer tubes of 6 ml capacity without anticoagulant. The vacutainer tubes are then placed in a centrifugal machine at 3000 revolutions per minute (rpm) for 10 minutes, after which it settles into the following layers: red lower fraction containing red blood cells, upper straw colored cellular plasma and the middle fraction containing the fibrin clot. The upper straw colored layer is then removed and middle fraction is collected, 2 mm below lower dividing line, which is the prf.

B) surgical procedure- the same surgical procedure will be carried out as seen in the control group. After the procedure while suturing, coronally anchored sutures will be placed engaging the 2–3 mm apical gingival margin of individual tooth using 4-0 silk suture. The suture is secured at the midcoronal point of the facial aspect of each tooth with the help of composite resin button to prevent apical relapse of the gingival margin. Once coronal stabilization is achieved, freshly prepared prf membrane is inserted through the tunnel using the small periosteal elevator and spread it uniformly on recession defects. After complete and proper adaptation of the membrane the vertical incision is sutured for the primary closure. Complete surgical site is covered with coe-pack.

The following post-operative measures will be explained to the patients

1) suitable antibiotics (amoxicillin 500mg t.i.d. For 5 days), analgesic (diclofenac sodium 50 mg and paracetamol 500 mg t.i.d. For 5 days) will be prescribed, along with 0.2% chlorhexidine digluconate rinses 10 ml for 1 minute, twice daily for 2 weeks.

2)Sutures will be removed after 10 days postoperatively.

3)Patients will be instructed to avoid usage of toothbrush at surgical site. Teeth cleaning at surgical site will be initiated with gentle brushing with soft toothbrush in coronal direction after suture removal.

4)Each patient will be instructed for proper oral hygiene measure at each appointment.

All the parameters will be re-evaluated at 3 months and 6 months after surgery by the second blinded operator.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • At least 2 recession- type defects affecting adjacent teeth with Class І or class ІІ miller’s recession defects.
  • Recession depths ≥ 1mm.
  • Probing depth < 3mm without bleeding on probing.
  • Presence of identifiable CEJ.
  • Patient willing to give written informed consent.

排除标准

  • General contraindications to surgery.
  • Individuals with unacceptable oral hygiene.
  • Patients with active periodontal disease or systemic diseases or pregnancy.
  • Patients taking medications or having treatment with an effect on mucosal healing.
  • Patient who participated in clinical trial within past 6 months.

结局指标

主要结局

Reduction of gingival marginal recession depth

时间窗: Baseline to 6 months

次要结局

未报告次要终点

研究者

发起方
未提供

研究点 (1)

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