Management of RT1 gingival recession defects with and without 0.2 percent Hyaluronic acid as an adjunct to coronally advanced flap: A split mouth randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Probing Pocket Depth, Clinical Attachment Level, Recession Depth, Recession Width, Mean % root coverage, Keratinised Tissue width, Gingival Tissue Thickness
研究概览
简要总结
AIM- To assess and compare treatment outcomes of coronally advanced flap with and without Gengigel (0.2% Hyaluronic Acid) for RT1 gingival recession defects.
Objectives- The objectives of this study are:
1. To compare the percentage of root coverage at baseline and at the end of treatment for CAF alone.
2. To compare the percentage of root coverage at baseline and at the end of treatment for CAF with Gengigel.
To compare the clinical parameters (CAL/PPD/KTW/MRC) of test and control.
Patients satisfying inclusion and exclusion criteria will be randomly assigned into two groups by simple randomization method: -
Group A (control group) – Coronally Advanced Flap
Group B (test group) – Coronally Advanced Flap with application of 0.2% hyaluronic acid
All the recruited patients will be asked to sign an informed consent prior to the treatment.
All the patients will be examined at baseline(T0) for probing pocket depth [PPD], clinical attachment level [CAL], recession depth (RD), recession width (RW), keratinized tissue width (KTW) and gingival tissue thickness (GTT).
After initial periodontal examination at baseline, all the participants will undergo initial phase of treatment of thorough scaling and root planning
.
The surgical area will be prepared with adequate anesthesia using 2% lignocaine HCL containing 1:1,00,000 epinephrine. After local anesthesia and before the elevation of the flap, both the exposed root surfaces will be gently planned with a sharp Gracey no. 1–2 curettes to reduce root convexity. Immediately after, the root surface will be washed for 60 s with water spray. Intrasulcular incisions will be then made with a 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 oblique releasing incisions will be carried out from the mesial, and distal extremities of the horizontal incision beyond the mucogingival junction. A trapezoidal full-thickness flap will be raised with a periosteal elevator, until the mucogingival junction. Then a partial-thickness dissection will be carried out apically leaving the underlying periosteum in place. In addition, a mesiodistal and apical dissection parallel to the vestibular lining mucosa will be performed with a blade to release residual muscle tension and to facilitate the passive coronal displacement of the flap. The papillae adjacent to the involved tooth will be de-epithelized. The flap then advanced coronally and adapted to cover the cementoenamel junction
In the experimental group, hyaluronan gel (gengigel 0.2%) applied on the root surface using a sterile instrument prior to flap advancement and suturing whereas in the control group the flap will be advanced coronally without application of HA gel. Suturing of oblique releasing incisions will be performed with absorbable 5-0 braided coated Polygalactin 910 (Vicryl) sutures, while the coronal mesial and distal extremities of the flap will be secured by two single sutures placed in the interdental areas.
Immediately following surgery, use of ice packs was recommended for 3 h. All patients were instructed to discontinue tooth brushing, avoid trauma around the surgical site. In the event of pain, the use of ibuprofen + paracetamol (thrice daily) was recommended. A 0.2% chlorhexidine digluconate solution rinse was prescribed 2 times (60 s) daily for the first 10 days. The sutures were removed after 7 days. The patients were instructed to clean the surgical sites with a cotton pellet soaked in a 0.2% chlorhexidine digluconate solution twice daily for 10 days.
Assessment of all the study groups will be done as:
T0 =Periodontal examination with all the clinical parameters will be done at the baseline
T1= at 3months.
T2 = at 6 months.
On each visit, the area will be checked for meticulous plaque control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Systemically healthy patient with no co-morbidities.
- •Patients with a buccal recession on both sides of maxillary or mandibular arch with RT1 or Miller’s ClassI or Class II gingival recession defects.
- •Presence of a clearly identifiable CEJ and with at least 1mm of keratinized tissue apical to the recession.
- •Full mouth plaque score and Full mouth bleeding score less than 20percent.
- •History of no systemic antibiotics in the last 6 months.
- •No history of mucogingival or periodontal surgery at the experimental site.
排除标准
- •Pregnant or lactating females.
- •Patients with active periodontal disease.
- •Teeth with prosthetic crown or restoration with the cervical edge in the cervical area
- •Patients with presence of occlusal interferences such as mispositioned or rotated tooth.
- •History of chronic alcoholism.
- •History of smoking or use of smokeless tobacco.
结局指标
主要结局
Probing Pocket Depth, Clinical Attachment Level, Recession Depth, Recession Width, Mean % root coverage, Keratinised Tissue width, Gingival Tissue Thickness
时间窗: At baseline, 3 months and 6 months
次要结局
未报告次要终点
研究者
UJJWAL KUMAR GUPTA
H.P. Government Dental College and Hospital, Shimla
