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

NCT ID: NCT04338139

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-07-30

Brief Summary

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

Conditions

Bone Regeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bio-oss Collagen

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

Group Type: EXPERIMENTAL

bone regeneration

Intervention Type: PROCEDURE

bone regeneration using bio-oss collagen

Interventions

bone regeneration

bone regeneration using bio-oss collagen

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saint-Joseph University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint-Joseph University

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

USJ-2019-112

Identifier Type: -

Identifier Source: org_study_id