Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration

Saint-Joseph University

Status: Unknown

Conditions: Bone Regeneration

Treatments: Procedure: bone regeneration

Study type: Interventional

Funder types: Other

Identifiers

NCT04338139

USJ-2019-112

Details and patient eligibility

About

to validate the capacity of bio-oss collagen (xenograft block+ collagen type I) placed solely without a membrane on a thin (0.5-1.8mm) buccal bone wall after delayed implant placement to regenerate bone volume. 30 patients requiring dental implants and presenting a deficient bone ridge (a ridge with reduced marginal bone width ≤ 2mm) were selected. The bone regeneration technique used in this study:

• Pre-operatively:

  • cone beam computed tomography CBCT
  • 1 minute mouthwash with a 0.12% Chlorhexidine solution
  • Full thickness muco-periosteal flap and ridge curettage.
  • Drilling and implant placement (any implant system)
  • Adjustment and placement of the "Bio-Oss Collagen" in the regeneration site without a fixation membrane.
  • Hermetic wound closure with U-shaped and simple stitches using 5/0 and 6/0 PGA resorbable material.

• Post-operatively:

  • Medication:

    • Amoxicilline (1g) or Clindamycine (300mg)
    • Analgesic, (paracetamol + codeine)

  • Mouthwash with a solution of 0.12% Chlorhexidine

  • cone beam computed tomography CBCT

    • 4 months postoperatively: CBCT

Bio-oss collagen is placed on the buccal side after implant placement and adapted to have the bone defect morphology. the full thickness flap is then closed without membrane placement and the bone bock is fixed in place through sutures only. CBCT images were taken immediately postoperatively and at 4 months after bone grafting. Imaging superposition (on ITK software) and measurements of buccal bone gain were effectuated to evaluate the efficiency of this regeneration technique. evaluation of buccal bone regeneration through linear radiographic measurements and evaluation of the % of grafted bone resorption will indicate the success of this technique

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age >18 years old
• Smoking <10 cigarettes/day (Light smoker)
• Good general health.
• Absence of acute infection: edema, suppuration, abscess, spontaneous bleeding.

Exclusion criteria

• A pregnant or nursing mother
• Pathologies that may impair bone healing: diabetes, autoimmune diseases, corticosteroids, chemotherapy.

Orthodontic treatment in progress or planned

• Adjacent risk teeth

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Bio-oss Collagen

Experimental group

Description:

90% xengeneic bovine bone partciles + 10% collagen type I

Treatment:

Procedure: bone regeneration