Composite Plug Vs D-PTFE Membrane in Socket Preservation

Официальное название

Evaluation of Socket Seal Using Flowable Composite Above Xenograft Compared to Dense Polytetrafluoroethylene (d-PTFE) Membrane in Ridge Preservation Procedures: a Randomized Controlled Clinical Trial

Обзор

The aim of the current study is to compare the effect socket sealing with flowable resin composite compared to dense polytetrafluoroethylene membrane after filling the extraction site with xenograft particles in terms of soft and hard tissue changes, procedural time, post operative pain, patients' satisfaction, and cost effectiveness.

Подробное описание

Implant placement has become the gold standard for replacing missing teeth. One of the biggest challenges present when placing implants is the lack of sufficient bone dimensions. This deficiency may be a common finding due to the process of post extraction remodeling where both bone height and width are reduced, complicating implant placement. As a result, several procedures have been suggested to address this issue. Socket preservation is one of the most implemented procedures used today to limit the amount of bone lost during post extraction remodeling. The current study was designed to compare the effectiveness of using flowable composite resin for socket sealing as an alternative to using d-PTFE membranes, bypassing the added time, cost and trauma needed for tunnel preparation and membrane tucking.

Вмешательства

• Процедура Socket preservation using xenograft and composite plug
  Extraction of hopeless teeth will be followed by grafting the socket with xenograft and coverage with injected flowable composite plug which will then be stabilized using 5.0 polypropylene suture material with a figure of eight suture.
• Процедура Socket preservation using xenograft and intentionally exposed d-PTFE
  Extraction of hopeless teeth will be followed by grafting the socket with xenograft and coverage with d-PTFE membrane which will the be left exposed intentionally. This will be followed by securing the membrane using 5.0 polypropylene suture material with a figure of eight suture.

Первичные конечные точки

• Change in horizontal bone dimension [Срок оценки: 4 Months]

Вторичные конечные точки (6)

• Change in Vertical bone dimension [Срок оценки: 4 Months]
• Keratinized tissue thickness [Срок оценки: 4 Months]
• Procedural time [Срок оценки: During surgery]
• Post-operative pain [Срок оценки: 1 week]
• Patient Satisfaction [Срок оценки: 2 weeks]
• Incidence of complications [Срок оценки: 4 Months]

Критерии участия

Критерии включения

• Patients having single non-adjacent hopeless maxillary tooth in the esthetic zone that are indicated for extraction.
• Patients with healthy systemic condition.
• Patients aged from 20 to 70 years old.
• Good oral hygiene.
• Accepts 4 months follow-up period (cooperative patients).

Критерии исключения

• Systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing.
• Previous bone augmentation to implant site.
• Untreated periodontal diseases.
• Para-functional habits such as bruxism and clenching.
• History of radiation therapy to the head and neck.
• Heavy smokers (≥ 10 cigarettes per day).
• Pregnant or lactating females.
• Alcoholism or drug abuse.
• Psychiatric problems.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of oral and dental medicine, Cairo university — Cairo

Идентификаторы

NCT: NCT06315413 · Composite plug vs d-PTFE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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