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

NCT05426616 | Recruiting DMC

• 1 other identifier: BC-11825
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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)

Conditions

Alveolar Ridge Enlargement

Keywords

Guided bone regeneration; Resorbable collagen membrane; Titanium reinforced d-PTFE membrane

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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

Study Arms (2)

Control group: Collagen membrane

ACTIVE COMPARATOR

(Xenoprotect, Nobel Biocare, Göteborg, Sweden)

Device: collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden)

Test group: titanium reinforced d-PTFE membrane

EXPERIMENTAL

(Creos Syntoprotect,Nobel Biocare AB, Göteborg, Sweden)

Device: titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden)

Interventions

collagen membrane (Creos Xenoprotect , Nobel Biocare AB, Göteborg, Sweden) DEVICE

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.

Control group: Collagen membrane

titanium reinforced d-PTFE membrane (Creos Syntoprotect , Nobel Biocare AB, Göteborg, Sweden) DEVICE

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.

Test group: titanium reinforced d-PTFE membrane

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (3)

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Centrum voor Parodontologie en Orale Implantologie

Zottegem, Oost-Vlaanderen, 9620, Belgium

RECRUITING

Parodonto

Zwijnaarde, Oost-Vlaanderen, 9052, Belgium

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

Study Officials

• Jan Cosyn, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Cosyn, Professor

CONTACT

093324017; jan.cosyn@ugent.be

Jan Cosyn, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 22, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

BE (3)