Comparative evaluation of VISTA technique alone and with concentrated growth factors (CGF) in the management of bilateral multiple adjacent gingival recession defects: A clinical study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement in periodontal status i.e. Root coverage at baseline, 3 months and 6 months in both groups.
研究概览
简要总结
Study will be conducted to evaluate efficacy of VISTA alongwith concentrated growth factor over VISTA alone in treatment of bilateralmultiple adjacent gingival recession
defects (millers class I/ II gingival recession defects)patients, clinically. A total of 20 participants (90 defects) affected withbilateral multiple adjacent gingival recession defects
including both male and female visiting the Department ofPeriodontics at VSPM Dental College and research centre Nagpur will berecruited for this study.
In each patient two sites will be randomly assigned as:
Group I (45 defects–Control site): Patientsexhibiting multiple gingival recession defects (millers class I/ II gingivalrecession defects) undergoing VISTA alone.
Group II (45 defects–Test site): Patientsexhibiting multiple gingival recession defects (millers class I/ II gingivalrecession defects) undergoing VISTA followed by placement of
CGF.
The primary outcome will be improvement in periodontalstatus i.e. Root coverage at baseline, 3 months and 6 months in both groups.
The secondary outcome will be improvement in Gingival index(GI), Width of keratinized gingiva (WKG), Probing depth (PD), Clinicalattachment level (CAL), Gingival thickness
(GT), Recession depth (RD) in gingival recession defectstreated with VISTA technique alone and with Concentrated Growth Factor(CGF)i.e. In both the groups at baseline, 3 and
6 months postoperatively.
A brief description of entire procedure will be given toevery patient before starting procedure. Written informed consent will be takenfrom the patients who wish to enrol in the
study.
For all participants following periodontal parameters willbe recorded:
-
Gingival index (GI-Loe and Silness).
-
Width of keratinized gingiva (WKG).
-
Probing depth (PD).
-
Clinical attachment level (CAL).
-
Gingival thickness (GT).
-
Recession depth (RD).
Evaluation of Root coverage percentage
Post-operatively root coverage percentage of each groupwill be evaluated using the following formula
(Preoperative recession depth - Postoperative recessiondepth)
------------------------------------------------------------------------------× 100
Preoperative recession depth
The above parameters will be recorded with the UNC-15periodontal probe.
Initial therapy will consist of detailed oral hygieneinstructions and Scaling Root Planing (SRP). A re-evaluation examination willbe performed at 6 weeks following the completion of
initial therapy to confirm the need for surgery. Clinicalparameters will be evaluated at baseline. Under local anaesthesia, verticalincision of 3mm in length will be given from
attached gingiva to alveolar mucosa followed bysub-periosteal tunnel preparation with the help of special set of periostealelevators (VISTA 1,2,3,4) through vestibular access. This
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研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients exhibiting bilateral multiple gingival recession defects (Miller Class I or II recession) with no interproximal hard and soft tissue destruction will be selected.
- •Patients with more than or equal to 1mm of attached gingiva at gingival recession sites.
排除标准
- •Patients with history of any known systemic disease, bone metabolism that would alter the healing response of the oral tissues will be excluded.
- •Smoker patients.
- •Patients who are pregnant and lactating mothers will be excluded from study.
- •Patients who have undergone periodontal therapy in the past 6 months will also be excluded.
结局指标
主要结局
Improvement in periodontal status i.e. Root coverage at baseline, 3 months and 6 months in both groups.
时间窗: baseline, 3 months and 6 months.
次要结局
- Improvement in Gingival index (GI), Width of keratinized gingiva (WKG), Probing depth (PD), Clinical attachment level (CAL), Gingival thickness (GT), Recession depth (RD) in gingival recession defects treated with VISTA technique alone and in combination with concentrated growth factor at baseline, 3 and 6 months postoperatively(Baseline, 3 months, 6 months)