Comparative evaluation of the Efficacy of Injectable Platelet rich fibrin and Hemolaser Therapy in Interdental papilla Reconstruction A clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Papillary Regeneration
研究概览
简要总结
1. All the subjects who fulfilled the eligibility criteria will be educated and motivated for the treatment. Written Informed consent will be obtained from all the patients who shows their willingness for participation in the study. Following this, the subjects will undergo supragingival and subgingival Professional Mechanical Plaque removal (PMPR) with ultrasonic scalers and hand instrumentation completed 3 -4 weeks prior to the procedure.
2.Pre-procedural preparation; Stent Preparation; Individually fabricated occlusal/incisal stents will be made for standardization of the measurement. These stents will cover the incisal surface in the mesial and distal directions, extending to the teeth to cover the incisal and mid-coronal third of labial and lingual surfaces. A groove will be incorporated into the interdental part of the stent on the labial aspect to ensure the placement of the probe parallel to the tooth surface to measure the tip from a reference point on the stent.
3.Phenotype determination: The estimation of keratinized tissue width is done by using a UNC-15 probe attached with an endodontic rubber stopper. The upper lip will be stretched to determine the mucogingival Junction & Then the UNC-15 probe will be placed to measure the keratinized tissue width (KTW) from Mucogingival junction to the marginal gingiva. Gingival thickness will be assessed mid buccally halfway between the mucogingival junction and marginal gingiva using an endodontic spreader fitted with a rubber stopper and measured on the probe.
4.Following the phase I periodontal therapy, the clinical parameters will be recorded & clinical photographs will be taken prior to the procedure.
5.I-PRF Preparation I-PRF will be prepared as per the protocol by Miron et al (2017). 10ml of intravenous blood will be drawn from the patient and transferred to plastic non-coated test tubes. The blood then be immediately centrifuged at 700rpm for 3 minutes. The i-PRF will be withdrawn in an insulin syringe and used.
6.Procedure for injecting I-PRF After administration of Local anesthesia (1:80,000) at the treatment site, the insulin syringe filled with I-PRF will be inserted at a 45° angle ensuring the bevel was up by pointing the slant of the needle upward. I-PRF will be injected 2–3 mm apical to the tip of the papilla before the liquid turns into a gel consistency.
7.Hemolasertherapy After the application of topical anesthetic agent, Points will be marked on the gingiva with a tissue marker. Three points per tooth, and one point between the labial and lingual papilla. PBMT will be applied with a diode laser in two stages:
•The first PMBT will be applied before bleeding to stimulate local microcirculation.
•The second PMBT will be applied immediately after bleeding to stimulate stem cells.
Each spot will be irradiated with 660nm diode laser at a power setting of 100 mW for 20 seconds/ maximum energy of 2J per point
- Pricks will be made on the gingiva with explorer tip on every bleeding point marked. The blood will be allowed to flow into the sulcus and the interdental embrasure. The bleeding spots will be then irradiated with the same power setting.
9.The follow-ups will be conducted at 1 month, 3 months & 6 months post treatment to assess the sustainability of the esthetic results.
•The primary outcome will be Papillary Regeneration
•The secondary outcomes will be an improvement in
a.Plaque Index
b.Gingival Index
c.Gingival thickness
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 and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects exhibiting a healthy periodontium aside from deficient papilla as determined by score 2 of Cardaropoli Papilla Presence Index Presence of good oral hygiene maintenance Systemically healthy patients Non smoker.
排除标准
- •Immunocompromised patients Pregnant and lactating women Patients who have undergone periodontal surgery in same area within last 6 months Patients under any medication known to affect the periodontium Patients with bruxism Patients exhibiting parafunctional habits and traumatic occlusion.
结局指标
主要结局
Papillary Regeneration
时间窗: 1 month 3 months and 6 months
次要结局
- The secondary outcomes will be an improvement in(Plaque Index)
研究者
Deepikashree K
Adhiparasakthi Dental College and Hospital
