Идёт набор NCT07535060

Pontic Site Development With or Without Fixed Partial Denture

Без фазы С лечением Mucogingival Defects Pontic Site Development Keratinized Tissue Deficiency Connective Tissue Graft

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: Connective Tissue Graft (CTG).
Кому может быть актуально: Состояния в реестре: Mucogingival Defects, Pontic Site Development, Keratinized Tissue Deficiency, Connective Tissue Graft. Базовые параметры: от 18 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: Египет
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

Clinical and Volumetric Evaluation of Soft Tissue Augmentation Using Connective Tissue Graft (CTG) in Pontic Site Defects With and Without Fixed Partial Dentures. A Non-randomized Clinical Trial.

Обзор

This study aims to evaluate the effectiveness of soft tissue augmentation using connective tissue graft (CTG) in pontic site defects. It compares clinical and volumetric outcomes between sites with an existing fixed partial denture (FDP) and sites without an FDP. Following tooth extraction, alveolar ridge resorption often leads to soft tissue defects that can compromise esthetics, function, and prosthetic outcomes. CTG is considered the gold standard for soft tissue augmentation due to its predictable improvement in tissue thickness and stability. In this non-randomized clinical trial, patients with single edentulous sites in the esthetic zone will undergo CTG using a standardized surgical technique. The primary outcome is keratinized tissue thickness, while secondary outcomes include keratinized tissue width, volumetric soft tissue changes, esthetic evaluation (Pink Esthetic Score), plaque index, post-operative pain, and patient satisfaction. Clinical and digital assessments will be conducted preoperatively and at follow-up intervals up to 6 months. The study aims to determine whether performing CTG around an existing bridge provides comparable or improved outcomes compared to sites without a bridge, potentially offering a less invasive alternative to prosthetic replacement.

Подробное описание

Alveolar ridge resorption following tooth extraction frequently results in soft tissue deficiencies that compromise esthetic outcomes, prosthetic design, phonetics, and oral hygiene. In pontic site defects, inadequate soft tissue volume may lead to poor emergence profile, food impaction, and patient dissatisfaction, especially in the esthetic zone.

Soft tissue augmentation using connective tissue graft (CTG) is widely recognized as a reliable technique for improving tissue thickness and contour. However, limited evidence exists regarding its effectiveness when performed around an existing fixed partial denture (FDP), where removal of the prosthesis is often considered necessary before augmentation.

This study aims to evaluate whether soft tissue augmentation can be successfully performed without removing an existing prosthesis, and whether outcomes are comparable to sites where no prosthesis is present.

A non-randomized, parallel clinical design will be used to compare two clinical scenarios: pontic sites associated with an existing FDP and pontic sites without an FDP. The same surgical approach will be applied in both conditions to ensure consistency, with the presence or absence of the prosthesis being the primary distinguishing factor.

All procedures will be carried out under standardized clinical conditions at the Faculty of Dentistry, Cairo University. Patients will undergo initial periodontal preparation prior to surgical intervention. The augmentation procedure will be performed using a connective tissue graft placed through a minimally invasive pouch technique to enhance soft tissue volume and contour.

Follow-up assessments will be conducted over a 6-month period to evaluate healing, tissue stability, and overall clinical performance.

The significance of this study lies in its potential to support a less invasive treatment approach by eliminating the need for prosthesis removal, which may reduce treatment time, cost, and patient discomfort while maintaining satisfactory clinical and esthetic outcomes.

Вмешательства

Процедура Connective Tissue Graft (CTG)
Soft tissue augmentation will be performed using a subepithelial connective tissue graft (CTG) harvested from the palate and placed at the pontic site using a minimally invasive pouch/tunnel technique. The procedure aims to increase soft tissue thickness and improve contour in edentulous ridge defects. The same surgical protocol will be applied in all participants, with variation based only on the presence or absence of an existing fixed partial denture.

Первичные конечные точки

Keratinized Tissue Thickness [Срок оценки: Baseline and 6 months]

Вторичные конечные точки (7)

Keratinized Tissue Width [Срок оценки: Baseline and 6 month]
Volumetric contour changes [Срок оценки: Baseline, 3 months, and 6 months]
Pink Esthetic Score (PES) [Срок оценки: 6 months]
Blinded assessment for esthetics [Срок оценки: 6 months]
Post-operative pain [Срок оценки: Day 3, day 7, and day 14]
Patient satisfaction [Срок оценки: 6 months]
Plaque Index [Срок оценки: Baseline and 6 Months]

Критерии участия

Критерии включения

Patients will on missing tooth in the esthetic zone (2nd premolar to 2nd premolar), missing at least 3 months prior to recruitment, with or without FPD
Systemically free patient
≥18 years of age
Intact gingival tissue with at least 2mm keratinized tissue in adjacent teeth
Patients accept to provide informed consent