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

Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration: a Human Study

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

Study Overview

• Status: Unknown
• Conditions: Bone Regeneration
• Intervention / Treatment: Procedure: bone regeneration

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 1104 2020
    • Saint-Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bio-oss Collagen; 90% xengeneic bovine bone partciles + 10% collagen type I	Procedure: bone regeneration; bone regeneration using bio-oss collagen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations	cbct radiographic measurements	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
linear measurements of the amount of grafted bone resorption	cbct radiographic measurements	1 year

Collaborators and Investigators

• Sponsor: Saint-Joseph University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: April 5, 2020
• First Submitted That Met QC Criteria: April 5, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: USJ-2019-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: article publication
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: article publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No