Titanium Reinforced d-PTFE Membrane Versus Collagen Membrane For Guided Bone Regeneration

Официальное название

A Randomized Controlled Trial Comparing Titanium Reinforced d-PTFE Membrane to Collagen Membrane for Guided Bone Regeneration at Single Tooth Sites in the Premaxilla: a Clinical, CBCT and Histomorphometric Analysis

Обзор

After tooth extraction, shrinkage of the bone is expected with 50% reduction of alveolar width. Patients at least 3months after tooth extraction and in need of single oral implant placement in the anterior maxilla with both neighboring teeth present, were invited to participate in an inter-subject RCT if insufficient residual alveolar bone was left for proper implant placement. Guided bone regeneration has been used to recreate bone volume. A combination of xenogenous bone (Creos Xenogain , Nobel Biocare AB, Göteborg, Sweden) and autologous bone chips in a 1:1 ratio, is protected by a membrane fixated in the bone. A resorbable, non-stable membrane (Creos Xenoprotect, Nobel Biocare AB, Göteborg, Sweden) or non-resorbable titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden) can be used. This study aims to compare the effectivity of the two membranes by measuring changes in bone dimensions. The resorbable membrane has the advantage that it does not need to be removed, whereas the titanium reinforced membrane can protect the rebuilt volume better against external forces. Patients start to take systemic antibiotics (Amoxicilline 1g) and anti-inflammatory medication (ibuprofen 600 mg) 1h pre-operatively. Following local anesthesia (Septanest special, Septodont, Saint Maur des Fossés, France) and oral disinfection (Corsodyl mouth rinse, GSK, Wavre, Belgium), a large mucoperiosteal flap will be raised with two vertical releasing on each side of the edentulous space and at the distal aspect of the second neighboring tooth. The flap extends to the base of the alveolar process to allow full access. Autogenous bone chips are harvested from the retromolar area with bone scrapers and/or from an edentulous site using ACM bone collector (NeoBiotech, Guro-gu Seoul, Republic of Korea). DBBM particles (Xenogain, Nobel Biocare, Göteborg, Sweden) soaked in blood are mixed with autogenous bone chips to a ratio of 1/1. After having made multiple bone perforations at the buccal aspect of the recipient site, the mixture of bone chips and DBBM is applied. An individualized collagen membrane (Xenoprotect, Nobel Biocare, Göteborg, Sweden) or a non-resorbable titanium reinforced d-PTFE membrane is attached on top using membrane fixation pins. Prior to fixation of the final pin, bone grafting material is additionally applied from the lateral aspect to ensure that it is properly packed under the membrane and fully stable. Following release of the periosteum and muscle insertion, tension-free primary wound closure is achieved with horizontal mattress 4/0 titanium reinforced d-PTFE sutures and single 6/0 monofilament sutures. Patients continue the intake of antibiotics and anti-inflammatory medication for 7 days and use an oral mouthrinse during 2 weeks. Sutures are removed after 2 weeks, and an implant is installed after 9 months following 3D implant planning. A sample size calculation indicated 17 patients to be included per group. To compensate for one drop-out, 18 patients would be treated with collagen membrane and 18 would be treated with titanium reinforced d-PTFE. Changes in horizontal bone dimensions over time is the primary outcome. Prior to surgery, immediately after GBR, at 9 months, at 3 years and 5 years a CBCT is taken. Every CBCT is superimposed to the baseline CBCT in designated software and horizontal buccal bone dimensions are measured. Secondary outcomes include * Membrane exposure * Intrasurgical changes in bone crest width over time * Intrasurgical assessment of bone quality at implant placement at the palatal, midcrestal and buccal aspect * Need for re-grafting at implant placement * Need for soft tissue grafting at implant placement * Need for augmentation of keratinized mucosa at implant placement * Volumetric increase in buccal bone at 3 and 5 years * Peri-implant health at 3 and 5 years by means of intra-oral radiograph * Esthetic outcomes at 3 and 5 years * Histomorphometric analysis on 20 cases (10 per group)

Вмешательства

• Устройство collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden)
  A mucoperiosteal flap will be raised with two vertical releasing on each side of the edentulous space. Autogenous bone chips are harvested from the retromolar area with bone scrapers and/or from an edentulous site using ACM bone collector. DBBM particles soaked in blood are mixed with autogenous bone chips to a ratio of 1:1. After having made multiple bone perforations at the buccal aspect of the recipient site, the mixture of bone chips and DBBM is applied. An individualized collagen membrane i
• Устройство titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden)
  A mucoperiosteal flap will be raised with two vertical releasing on each side of the edentulous space. Autogenous bone chips are harvested from the retromolar area with bone scrapers and/or from an edentulous site using ACM bone collector. DBBM particles soaked in blood are mixed with autogenous bone chips to a ratio of 1:1. After multiple bone perforations at the buccal aspect of the recipient site, the mixture of bone chips and DBBM is applied.A titanium reinforced d-PTFE membrane is attached

Первичные конечные точки

• Changes in horizontal bone dimensions over time [Срок оценки: baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4]

Вторичные конечные точки (10)

• Membrane exposure [Срок оценки: During the 9 months of healing after GBR.]
• Intrasurgical changes in bone crest width over time [Срок оценки: Baseline, after GBR and 9 months after GBR during implant placement procedure.]
• Bone type: clinician perception (hand feel resistance) [Срок оценки: t2 = 9 months after GBR, at implant placement]
• Bone dimensions vertically and horizontally [Срок оценки: t2 = 9 months after GBR, at implant placement]
• Buccal soft tissue thickness [Срок оценки: t2 = 9 months after GBR, at implant placement]
• Buccal keratinized soft tissue width [Срок оценки: t2 = 9 months after GBR, at implant placement]
• Volumetric changes in buccal bone at 3 and 5 years [Срок оценки: baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4]
• Peri-implant health [Срок оценки: At 3 and 5 years]
• Pink Esthetic Score [Срок оценки: At 3 and 5 years]
• Histomorphometric analysis [Срок оценки: t2 = 9 months after GBR, at implant placement]

Критерии участия

Критерии включения

• good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)
• presence of a single tooth gap in the anterior maxilla (15-25) with both neighboring teeth present
• failing tooth at least 3 months earlier removed

Критерии исключения

• systemic diseases
• smoking; (history of) periodontal disease
• untreated caries lesions
• pregnancy (will be explicitly asked)

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

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 3 центра

• Universitair Ziekenhuis Gent — Ghent
• Centrum voor Parodontologie en Orale Implantologie — Zottegem
• Parodonto — Zwijnaarde

Публикации

• Hindryckx M, De Bruyckere T, Hitz-Steiger S, Seyssens L, Shtino R, Younes F, Thoma D, Cosyn J. A Multi-Center RCT Comparing Titanium-Reinforced dPTFE Membrane to Collagen Membrane in Horizontal Bone Augmentation at Single Sites in the Anterior Maxilla: Clinical and Histological Outcomes. Clin Implant Dent Relat Res. 2025 Dec;27(6):e70097. doi: 10.1111/cid.70097. PMID 41185408
• Hindryckx M, De Bruyckere T, De Buyser S, Seyssens L, Shtino R, Younes F, Cosyn J. A Multi-Centre Randomised Controlled Trial Comparing dPTFE Membrane to Collagen Membrane in Lateral Bone Augmentation at Single Sites in the Anterior Maxilla: 1-Year Results. J Clin Periodontol. 2025 Aug;52(8):1136-1146. doi: 10.1111/jcpe.14174. Epub 2025 Apr 29. PMID 40298001

Идентификаторы

NCT: NCT05426616 · BC-11825

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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