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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04338139
Enrollment
30
Registered
2020-04-08
Start date
2020-01-01
Completion date
2021-07-30
Last updated
2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Regeneration

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

Interventions

PROCEDUREbone regeneration

bone regeneration using bio-oss collagen

Sponsors

Saint-Joseph University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations1 yearcbct radiographic measurements

Secondary

MeasureTime frameDescription
linear measurements of the amount of grafted bone resorption1 yearcbct radiographic measurements

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026