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

Not Applicable

• Conditions: Bone Regeneration
• Interventions: Procedure: bone regeneration

• Registration Number: NCT04338139
• Lead Sponsor: Saint-Joseph University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-05
• Study First Submitted QC: 2020-04-05
• Study First Posted: 2020-04-08
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10
• Primary Completion: 2020-12-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bio-oss Collagen	bone regeneration	90% xengeneic bovine bone partciles + 10% collagen type I

Primary Outcome Measures

Name	Time	Method
linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations	1 year	cbct radiographic measurements

Secondary Outcome Measures

Name	Time	Method
linear measurements of the amount of grafted bone resorption	1 year	cbct radiographic measurements

Trial Locations

Locations (1)

Saint-Joseph University; 🇱🇧 Beirut, Lebanon