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

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

Sponsors

Lead Sponsor: University Ghent

Source University Ghent
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)

Overall Status Recruiting
Start Date 2022-06-01
Completion Date 2027-12-01
Primary Completion Date 2023-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in horizontal bone dimensions over time baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4
Secondary Outcome
Measure Time Frame
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
Buccal keratinized soft tissue width t2 = 9 months after GBR, at implant placement
Volumetric changes in buccal bone at 3 and 5 years baseline = t0, immediately after GBR = t1, at 9 months= t2, 3 years = t3 and 5 years=t4
Peri-implant health At 3 and 5 years
Pink Esthetic Score At 3 and 5 years
Histomorphometric analysis t2 = 9 months after GBR, at implant placement
Enrollment 36
Condition
Intervention

Intervention Type: Device

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

Description: 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.

Arm Group Label: Control group: Collagen membrane

Intervention Type: Device

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

Description: 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.

Arm Group Label: Test group: titanium reinforced d-PTFE membrane

Eligibility

Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - systemic diseases - smoking; (history of) periodontal disease - untreated caries lesions - pregnancy (will be explicitly asked)

Gender:

All

Minimum Age:

21 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jan Cosyn, Professor Principal Investigator University Ghent
Overall Contact

Last Name: Jan Cosyn, Professor

Phone: 093324017

Email: [email protected]

Location
Facility: Status: Contact:
Universitair Ziekenhuis Gent | Gent, Oost-Vlaanderen, 9000, Belgium Recruiting Jan Cosyn, Professor 093324017 [email protected]
Centrum voor Parodontologie en Orale Implantologie | Zottegem, Oost-Vlaanderen, 9620, Belgium Recruiting Jan Cosyn, Professor 0496100121 [email protected] Thomas De Bruyckere, Doctor Sub-Investigator
Parodonto | Zwijnaarde, Oost-Vlaanderen, 9052, Belgium Recruiting Faris Younes, Doctor [email protected]
Location Countries

Belgium

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control group: Collagen membrane

Type: Active Comparator

Description: (Xenoprotect, Nobel Biocare, Göteborg, Sweden)

Label: Test group: titanium reinforced d-PTFE membrane

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized clinical trial

Primary Purpose: Treatment

Masking: Single (Participant)

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