Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone

Официальное название

Hard and Soft Tissue Changes After Immediate Implant Placement Using Connective Tissue Graft With and Without Bone Grafting in the Esthetic Zone: A Randomized Clinical Trial

Обзор

Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group.

Подробное описание

This randomized clinical trial will evaluate the effect of using connective tissue graft and bone graft versus connective tissue graft, with customized healing abutments during immediate implant placement on volumetric mid facial recession .In patients with type I socket who need extraction in the anterior maxilla.

Вмешательства

• Процедура Immediate implant and connective tissue graft
  Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.
• Процедура Immediate implant with connective tissue graft and bone graft
  Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will placed to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment.

Первичные конечные точки

• Volumetric Analysis of Mid-facial recession [Срок оценки: Preoperative,3months,6months and 12 months]

Вторичные конечные точки (11)

• Volumetric analysis of Interdental papillae height [Срок оценки: Preoperative , 3 months, 6 months and 12 months]
• Bone formed labial to the implant [Срок оценки: Preoperative and 1 year]
• Horizontal labio-palatal bone collapse [Срок оценки: Preoperative and 1 year]
• Vertical crestal bone level changes [Срок оценки: Preoperative and 1 year]
• Gingival biotype [Срок оценки: Preoperative, 6 months and 12 months]
• Volumetric analysis of buccal contour [Срок оценки: Preoperative,3months,6months and 12 months]
• Horizontal labio-palatal bone collapse [Срок оценки: (Preoperative and 1 year)]
• Full mouth bleeding score (FMBS) [Срок оценки: Preoperative, 6months and 12 months]
• Pain and discomfort [Срок оценки: At 1,3 and 7 days after the surgery]
• Full mouth plaque score (FMPS) [Срок оценки: Preoperative, 6 months and 12 months]
• Pink Esthetic Score [Срок оценки: at 12 months]

Критерии участия

Критерии включения

• Patient-related criteria:
• Adults at or above the age of 18.
• Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
• The failing tooth will have adjacent and opposing natural teeth.
• Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
• Able to tolerate surgical periodontal procedures.
• Full mouth plaque and bleeding scores less than 20%.
• Compliance with the maintenance program.
• Provide informed consent.
• Accepts the one-year follow-up period.

Teeth related criteria:

• Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
• Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
• Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm

Критерии исключения

• Patients diagnosed with periodontal diseases.
• Current or previous smokers.
• Pregnant and lactating females.
• Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
• Patients with active infection related at the site of implant/bone graft placement.
• Patients with parafunctional habits

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06592079 · 924

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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