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临床试验/CTRI/2024/07/071304
CTRI/2024/07/071304尚未招募3 期

Comparative Evaluation of Coronally Advanced Flap in Conjunction with Concentrated Growth Factor versus Coronally Advanced Flap with Platelet Rich Fibrin Membrane in patients with Cairos RT1 Isolated Gingival Recession Defects

Ramya V1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
39
试验地点
1
主要终点
Complete root coverage

研究概览

简要总结

·    Patients recruited for the study will receive detailed explanations regarding the procedure and written informed consent will be obtained from each patient

a   At the baseline the clinical parameters such as Plaque Index, Gingival Index, Pocket Probing Depth, Clinical Attachment Level, Recession Depth, Recession Width, Keratinized Gingival Width, Gingival Thickness will be measured

·   All the patients will undergo phase I therapy of treatment consisting of thorough Supragingival Professional Mechanical Plaque Removal (PMPR) and oral hygiene instructions will be given to the patient. Patient will be re-evaluated after 3 weeks of Supragingival Professional Mechanical Plaque Removal(PMPR) to assess the plaque scores. Patient with plaque score less than 20 percentage will be eligible for the study. Within each patient randomly selected sites is divided into group A and group B

T The selected sites will be anaesthetized locally by administration of 2% xylocaine HCl anaesthetic solution containing adrenaline (1:80,000) prior to initiating the procedure

To To elevate the coronally advanced flap, two oblique vertical incisions of the triangular flap will be made at the level of cementoenamel junction and extending parallel to the soft tissue margin of the adjacent healthy teeth beyond the mucogingival line.

T The flap will then be elevated following a split-full-split-thickness approach in the coronal to apical direction and muscle attachment at mucogingival level will be relieved to sufficiently mobilize the flap and  to advance it coronally by 1mm to cover the gingival recession.

De epithelisation of the interdental papilla will be performed to conform to the anatomic papilla.

After the elevation of flap, the root surface will be debrided with the use of ultrasonic scaler and curettes. It is considered that only the portion of the root exposure with loss of clinical attachment (gingival recession + probable gingival sulcus/pocket) will be instrumented. Exposed root surfaces within the areas of anatomic bone dehiscence will not be instrumented, avoid damaging connective tissue fibres still attached to the root cementum

Adequate flap mobilization during coronal advancement will be ensured when the marginal gingiva of the flap is capable of reaching a level coronal to the cementoenamel junction of the tooth in the surgical area and the surgical papilla should cover the anatomic papilla

Intravenous blood will be collected from patients during these procedures in 10ml glass sterile tubes without anticoagulant solutions. The samples will then be immediately centrifuged using centrifuge machine to obtain either Concentrated Growth Factor or Platelet Rich Fibrin

In Group A Concentrated growth factor will be placed

Group B Platelet Rich Fibrin will be placed

Both Group A and Group B will receive simple interrupted sutures for the vertical incisions and sling sutures will be given to stabilize the papilla using 5-0 vicryl sutures. Post operative instructions and medications will be provided to the patient. Patients will be instructed not to brush the teeth in the operated area until further instructions

Patients will be instructed to rinse with chlorhexidine digluconate (0.2%) twice daily

Patients will be scheduled for a follow-up appointment after 2 weeks for further assessment

The clinical parameters such as Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level, Recession Depth, Recession Width, Keratinized Gingival Width, Gingival Thickness will be measured at 3 months and 6 months postoperatively

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy individuals aged between 20 to 60 years Patients with Cairo’s RT1 isolated gingival recession bilaterally Patients with gingival recession greater than or equal to 2mm depth and width Patient should have a minimum of 3 mm of keratinized gingiva present apical to the exposed root with no loss of inter dental bone or soft tissue, and adequate thickness of keratinized gingiva in the surgical site.

排除标准

  • Systemic illness known to affect the outcome of periodontal therapy Patients who use tobacco in any form Pregnant and lactating women Patients undergoing orthodontic therapy Patients on antibiotics in last 6months.

结局指标

主要结局

Complete root coverage

时间窗: Baseline,3 months and 6 months

次要结局

  • Improvement in Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level, Recession Depth, Recession Width, Keratinized Gingival Width, Gingival Thickness(Baseline,3 months & 6 months)

研究者

发起方
Ramya V
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ramya V

Adhiparasakthi dental college and hospital

研究点 (1)

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