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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
Sponsor study identifier
interventional
36
1 country
3
Study Start
June 1, 2022
Actual (reported)Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2022
Actual (reported)June 11, 2022
Actual (reported)June 22, 2022
Actual (reported)December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Changes in horizontal bone dimensions over time
At T0, t1, t2, t3 and t4 a CBCT is taken. Every CBCT is superimposed to the baseline CBCT in designated software and horizontal buccal bone dimensions are measured at 1 mm, 3 mm, 5 mm, 7 mm and 9 mm from the crest. The changes from baseline in horizontal bone dimensions at the different levels is calculated.
baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4
Membrane exposure
During the 9 months of healing after GBR.
Intrasurgical changes in bone crest width over time
Baseline, after GBR and 9 months after GBR during implant placement procedure.
Bone type: clinician perception (hand feel resistance)
t2 = 9 months after GBR, at implant placement
Bone dimensions vertically and horizontally
t2 = 9 months after GBR, at implant placement
Buccal soft tissue thickness
t2 = 9 months after GBR, at implant placement
(Xenoprotect, Nobel Biocare, Göteborg, Sweden)
(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 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 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.
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
Centrum voor Parodontologie en Orale Implantologie
Zottegem, Oost-Vlaanderen, 9620, Belgium
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.
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.
Jan Cosyn, Professor
University Ghent
Jan Cosyn, Professor
CONTACT
First Submitted
June 11, 2022
First Posted
June 22, 2022
Study Start
June 1, 2022
Actual (reported)Primary Completion
December 31, 2028
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 on top using membrane fixation pins. Care is taken to leave a distance of at least 1 mm between the membrane and neighboring teeth. 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. The membrane is removed after 9 months, prior to implant placement.
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Parodonto
Zwijnaarde, Oost-Vlaanderen, 9052, Belgium
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 15, 2024
Record last verified: 2024-07
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