A comparative evaluation of the efficacy of amniotic membrane and chorion membrane along with demineralized freeze-dried bone allograft using coronally advanced flap technique in the treatment of millers class I and class II gingival recession defects - A 24 weeks clinical and radiological study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in clinical parameters of probing depth and soft tissue volume
研究概览
简要总结
AIM: Therefore the aim of the study is to compare and evaluate the efficacy of amniotic membrane with DFDBA versus chorion membrane with DFDBA using coronally advanced flap technique in the treatment of Miller’s class I and class II gingival recession defects clinically and radiologically.
METHODOLOGY:
PRE SURGICAL PROCEDURE
— Routine laboratory blood investigations will be carried out.
— Phase l therapy, that will include oral hygiene instructions, scaling and root planing using hand and ultrasonic instruments, will be performed.
— The CBCT measurements will be taken for each group i.e. Group A (Amniotic membrane and DFDBA) and Group B (Chorion membrane and DFDBA) at baseline and 24 weeks.
— Patients will be re-evaluated 3-4 weeks after phase l therapy for plaque maintenance.
— Patient with Plaque index39 score <1.0 will be included in the study.
— Appropriate antibiotic prophylaxis will be given to the patient before surgery.
SURGICAL TECHNIQUE
— All surgical procedures will be carried out by one operator.
— The sites will be randomly assigned to Group A or Group B through a computer generated data and will be assigned of either of the two groups before surgery.
— CAF was advocated utilizing the method depicted by Pini-Prato et al.
— The surgical area will be anaesthetised using 2% lignocaine hydrochloride containing 1:80,000 epinephrine. Before the elevation of the flap, both the exposed root surfaces will be gently planed with sharp Gracey curette to reduce root convexity. Immediately after, root conditioning will be done with 24% EDTA for 2-3 minutes41 followed by copious irrigation with normal saline for 30-60 seconds.
— Intrasulcular incisions will be given with B P blade (no.15) on the buccal aspect of the involved tooth. This incision will be horizontally extended to the adjacent papillae avoiding the gingival margin of the adjacent teeth. Two vertical releasing incisions will be carried out from the mesial, and distal extremities of the horizontal incision sufficiently beyond the mucogingival junction.
· A trapezoidal full�’ thickness flap will be raised with a periosteal elevator, 3-4mm beyond the apical crest of osseous dehiscence. Then a partial�’ thickness dissection will be carried out apically leaving the underlying periosteum in place.
— In Group A amniotic membrane and DFDBA will be placed and the flap will be advanced coronally where as in Group B chorion membrane and DFDBA will be placed followed by coronal flap advancement.
— Suturing will be performed with 4-0 vicryl suture to secure the flap and membrane at the required position.
POST SURGICAL CARE:
— Suitable antibiotic and analgesic will be prescribed for 5 to 7 days.
— Patient will be advised to rinse with 0.2% chlorhexidine digluconate twice a day for 2 weeks following surgery.
— Periodontal dressing and sutures will be removed 7-14 days after surgery.
— Post operative instructions and patient will be reinstructed to maintain oral hygiene.
— Each patient will be revaluated for periodontal maintenance and clinical parameters at 12 weeks and 24 weeks post operative will be recorded.
— CBCT measurements will be recorded for each group i.e. Amniotic membrane and DFDBA group and Chorion membrane and DFDBA group after 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •patients maintaining good oral hygiene with plaque index <
- •Patients willing to participate in the study by giving written consent.
- •Systemically healthy patients with class1 and class 2 gingival recession.
排除标准
- •Debilitating systemic or infectious disease or any disease that affects the periodontium.
- •Known allergy to any of the materials used in the study.
- •Poor compliance.
- •Pregnancy or lactating women.
- •Use of tobacco products or immunosuppressant drugs or corticosteroids.
- •History of previous root coverage procedures.
- •Patient undergoing orthodontic treatment.
- •Patients under anticoagulant treatment.
- •Patients with caries and restoration.
结局指标
主要结局
Improvement in clinical parameters of probing depth and soft tissue volume
时间窗: 12 weeks and 24 weeks
次要结局
- The buccal bone level is expected to increase.(24 weeks)
