Идёт набор NCT06988839

Effect Of Microneedling With Coronally Advanced Flap For Management of RT1 Gingival Recession In Thin Gingival Phenotype

Без фазы С лечением Gingival Recession

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Microneedling followed by coronally advanced flap, Coronally advanced flap with connective tissue graft.
Кому может быть актуально: Состояния в реестре: Gingival Recession. Базовые параметры: 20 лет — 50 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Индия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Patient-Centered And Clinical Outcomes Of Microneedling With Coronally Advanced Flap For Management of RT1 Gingival Recession In Thin Gingival Phenotype : A Randomized Controlled Clinical Trial

Обзор

The goal of this clinical trial is to explore the effect of microneedling to increase the gingival tissue thickness which could improve the outcome of root coverage in coronally advanced flap procedure in thin gingival phenotype. The main question it aims to answer is that : Does the use of microneedling procedure followed by coronally advanced flap has similar outcomes of root coverage in recession type 1 (RT1) gingival recession i.e. buccal gingival recessions without interdental clinical attachment loss in thin gingival phenotype as compared to coronally advanced flaps with connective tissue graft. Systemically healthy patients having isolated upper RT1 gingival recession will be assigned into two groups. Microneedling will be performed in one group (4 sessions each at a 10 days interval) followed by coronally advanced flap operation (at an interval of 2 months) and coronally advanced flap with connective tissue graft will be performed in the other group. Follow-up will be done at 1 month, 3 months and 6 months for evaluation of primary and secondary outcomes.

Подробное описание

The gingival phenotype affects the choice of mucogingival surgical technique for coverage of the root surface in gingival recession. It has been reported that a flap thickness of \> 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of \< 0.8 mm results in partial root coverage in coronally advanced flap procedure for Miller class I or II root coverage. Thus connective tissue graft (CTG) use is advocated in thin phenotype cases, for improved clinical and esthetic outcomes. Connective tissue graft increases the predictability of coronally advanced flap. Treatment by addition of connective tissue graft has some drawbacks like creation of a second surgical site, postoperative discomfort and long chair side time, leading the researchers to explore techniques less invasive in nature.

Microneedling (MN), also known as "percutaneous collagen induction therapy." It creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors, such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors, are released. In microneedling, the tissue responds as if experiencing minor trauma and the body's own collagen production is induced to preserve skin integrity. Microneedling as opposed to connective tissue grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the gingival thickness and keratinized tissue width of individuals with thin gingival phenotype. It is associated with higher patient acceptance, lesser surgical site co-morbidities and is a minimally invasive yet an effective approach to augment the gingiva. The histological analysis performed one year post microneedling sessions, showed increased collagen and elastic fiber accumulation in the reticular dermis, a thickened epidermis and a normal stratum corneum, showing its greater effect on gingival thickness.

The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by coronally advanced flap procedures in thin gingival phenotype. This technique is proposed to improve thin gingival phenotype by minimally invasive and non-surgical means.

Вмешательства

Процедура Microneedling followed by coronally advanced flap
Microneedling will be performed using a 30 gauge lancet needles, inserted until hard tissue is felt. It will be performed in 4 sessions at 10 day intervals, followed by coronally advanced flap procedure, 2 months post microneedling.
Процедура Coronally advanced flap with connective tissue graft
Coronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy.

Первичные конечные точки

Recession depth (RD) [Срок оценки: Baseline,1,3,6 months]
Recession width (RW) [Срок оценки: Baseline, 1 , 3 and 6 months]
Root coverage percentage (RC%) [Срок оценки: Baseline ,1,3 and 6 months]
Root Esthetic Score (RES) [Срок оценки: Baseline, 6 months]
Patient-centered outcomes [Срок оценки: Baseline,1,3 and 6 months]

Вторичные конечные точки (5)

Clinical Attachment level (CAL) [Срок оценки: Baseline, 1 , 3 ,6 months]
Probing pocket depth [Срок оценки: Baseline,1 ,3 and 6 months]
Plaque index [Срок оценки: Baseline, 1 ,3 and 6 months]
Gingival index [Срок оценки: Baseline,1,3 and 6 months]
Gingival thickness [Срок оценки: Baeline, 1 ,3 and 6 months]

Критерии участия

Критерии включения

Presence of isolated RT1 buccal maxillary gingival recessions in esthetic zone with thin gingival phenotype (Gingival thickness≤1mm) associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
Gingival Recession ≥2mm , Keratinized tissue width≥2mm and clinically identifiable cementoenamel junction
Age 20years-50 years
Patient demonstrating compliance for maintaining good oral hygiene after Phase 1 therapy Plaque index (PI) <1, Gingival Index (GI) <1
Providing a written and verbal informed consent.