Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes

Not Applicable

Recruiting

• Conditions: Bone Resorption
• Interventions: Procedure: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane; Procedure: Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane

• Registration Number: NCT06334159
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

Detailed Description

The aim of this clinical trial is to compare the horizontal bone gain when grafting a mixture of xenograft and allograft (50/50) with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

Study Timeline

• Study Start: 2020-11-05
• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-07-20
• Study Completion: 2027-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Men and women over 18 years old or older
2. Patients requiring Guided Bone Regeneration due to insufficient ridge width(≤5mm) to place dental implants, with sufficient vertical ridge height (≥9mm) from vital anatomical structures (the inferior alveolar nerve in the Mandible, or the sinus in the Maxilla)
3. One or more teeth missing in posterior zone (Premolars, and Molars)
4. Absence of active Periodontal disease
5. Good level of oral hygiene (Plaque index <25%)
6. Absence of systemic diseases that could influence the outcome of the therapy (Uncontrolled diabetes, osteoporosis, bisphosphonate medications)
7. Non smokers or light smokers (<10 cigarettes per day)
8. Informed consent signed

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Exclusion Criteria

1. Patients with sufficient ridge width (>5 mm) and height (≥9mm) from vital anatomical structure) requiring no GBR to place dental implants
2. Patients with severe horizontal and vertical defects requiring other surgical techniques.
3. Long-term non-steroidal anti-inflammatory drug therapy (3months).
4. Lactating females or currently pregnant women.
5. Severe cognitive or psychiatric disorders.
6. Unwillingness to return for follow-up examination.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Test Group	Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane	Horizontal Guided Bone Regeneration with a mixture of xenograft (Cerabone 0.5-1mm particles) and allograft (Maxgarft \<2mm particles) bone substitute (50/50) with fixed resorbable collagen membranes(Jason Membrane 20x30mm) with the use of pins (Titan Pins)
Control Group	Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane	Horizontal Guided Bone Regeneration with a mixture of xenograft (Cerabone 0.5-1mm particles) and allograft (Maxgarft \<2mm particles) bone substitute (50/50) with non-fixed resorbable collagen membranes (Jason Membrane 20x30mm)

Primary Outcome Measures

Name	Time	Method
Bone Width Gain	T3: 6 months after the Horizontal GBR	To compare the bone width gain between the test group and control group, 6 months after the horizontal GBR.; A caliper will be used in order to evaluate and compare the bone width gain at T1, T2, and T3 between the Test and Control Groups. These measurements are performed intra-operatively before the Horizontal GBR (T1), immediately after (T2), and at 6 months (T3) at the time of implant placement. Measurements will be performed at 1cm, 3cm, and 5cm apical from the bone crest at the regenerated area.
Horizontal Bone Gain	T3: 6 months after the Horizontal GBR	To compare the horizontal bone gain when grafting a mixture of xenograft and allograft (50/50) with non-fixed resorbable collagen membranes (control group) versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring GBR to facilitate implant placement at 6 months.; Along the 6 months, 3 Cone Beam Computed Tomography scans (CBCT) will be needed. At baseline (T1), the first CBCT will be taken before performing any surgical procedure to measure the initial width of the ridge. Immediately after the GBR (T2), a second CBCT scan will be taken, which will be useful to measure new ridge width in each group. Finally, at 6 month follow-up a third CBCT scan will be taken (T3) in order to assess the difference with T1 regarding amount of bone gain horizontally, and with T2 regarding horizontal dimensional stability of the grafted bone in each of the 2 groups.

Secondary Outcome Measures

Name	Time	Method
Post-surgical complications	T2-T3: From the surgery to 6 months	To compare the post-surgical complications that may occur between the test group and control group throughout the period of healing and during the following 6 months. The complications will be evaluated using the Healing Complications Classification, as suggested by Fontana et al. 2011. The healing post-surgical complications are divided into four classes, according to the presence and extent of exposure, as well as the presence of a purulent exudate: * Class I: membrane exposure \<3mm, no purulent exudate; * Class II: membrane exposure ≥3mm, no purulent exudate; * Class III: membrane exposure with purulent exudate; * Class IV: abscess, without membrane exposure
Patient's satisfaction	At 2-weeks follow up after the surgical procedure	To compare patient's satisfaction regarding the post-operative pain and compare it between the test group and control group throughout the period of healing and during the following 6 months, through the use of a Visual Analogue Scale (VAS). It is a 10cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patients will be asked to mark their average experience of discomfort and pain. The scores of the VAS will be obtained by measuring the distance in centimeters (0 to 10).
Histologic examination of the augmented bone at 6 months	At time of implant placement	To examine type of cells present after 6 months of procedure by performing histological examination to the sample harvested from the site with the use of an implant trephine drill. The histologic evaluation will be performed in order to evaluate the type of cells present at the site of augmentation
Horizontal Dimensional Stability	T3: 6 months after the Horizontal GBR	To compare the horizontal dimensional stability of the augmented ridges between the test group and control group after 6 months.; After the surgical procedure, a CBCT scan (T2) will be completed and the bone width will be assessed and compared with the bone width at 6 months postoperatively when a new CBCT scan (T3) will be completed before implant placement.

Trial Locations

Locations (1)

Georgios Markantonatos; 🇪🇸 Barcelona, Sant Cugat Del Vallès, Spain