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

Bone Regeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04338139
• Other study ID #: USJ-2019-112
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: April 2020
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Regeneration

Intervention

Procedure:
• bone regeneration
bone regeneration using bio-oss collagen

Locations

Country	Name	City	State
Lebanon	Saint-Joseph University	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations	cbct radiographic measurements	1 year
Secondary	linear measurements of the amount of grafted bone resorption	cbct radiographic measurements	1 year